Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19): SOR/2023-19

Canada Gazette, Part II, Volume 157, Number 4

Registration
SOR/2023-19 February 3, 2023

FOOD AND DRUGS ACT

P.C. 2023-69 February 3, 2023

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, makes the annexed Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) under section 30footnote a of the Food and Drugs Act footnote b.

Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19)

Amendments

1 Section 27 of the Medical Devices Regulations footnote 1 is amended by striking out “or” at the end of paragraph (a) and by adding the following after that paragraph:

2 Paragraph 61.2(2)(a) of the Regulations is replaced by the following:

3 (1) Paragraphs 61.4(1)(a) and (b) of the English version of the Regulations are replaced by the following:

(2) The portion of subsection 61.4(2) of the English version of the Regulations before paragraph (a) is replaced by the following:

(2) The information to be covered by the summary report is that in respect of

(3) Paragraph 61.4(2)(d) of the French version of the Regulations is replaced by the following:

(4) Subsections 61.4(3) and (4) of the Regulations are replaced by the following:

(3) The summary report shall contain a concise critical analysis of the information referred to in subsection (2).

(4) In preparing the summary report, the holder shall determine, on the basis of the critical analysis, whether what is known about the benefits and risks associated with the medical device has changed in any of the following ways:

(5) Subsection 61.4(5) of the English version of the Regulations is replaced by the following:

(5) The holder shall include the conclusions they reach under subsection (4) in the summary report.

(6) Subsection 61.4(6) of the Regulations is replaced by the following:

(6) If, in preparing the summary report, the holder concludes that what is known about the benefits and risks associated with the medical device has changed in any of the ways referred to in paragraphs (4)(a) to (c), they shall notify the Minister, in writing, within 72 hours after having reached the conclusion, unless that has already been done.

4 (1) The portion of subsection 61.5(1) of the Regulations before paragraph (a) is replaced by the following:

61.5 (1) The Minister may, for the purposes of determining whether a medical device meets the applicable requirements of sections 10 to 20, request that the holder of a medical device licence issued in respect of the device submit, within a specified time limit, any of the following:

(2) Subsection 61.5(2) of the English version of the Regulations is replaced by the following:

(2) The holder shall submit to the Minister the summary reports or information, or both, that the Minister requests within the time limit specified in the request.

5 Subsection 61.6(2) of the Regulations is replaced by the following:

(2) The holder shall retain the records for seven years after the day on which they were created.

6 (1) Paragraph 62.23(1)(b) of the Regulations is replaced by the following:

(2) Subsection 62.23(3) of the Regulations is replaced by the following:

(3) For greater certainty, subsections (1) and (2) do not remove the requirement for

7 The Regulations are amended by adding the following after section 68:

PART 1.1

Medical Devices for Use in Relation to COVID-19

Definitions

68.01 The following definitions apply in this Part.

authorization
means, unless the context requires otherwise, an authorization that is issued under section 68.12. (autorisation)
COVID-19
means the coronavirus disease 2019. (COVID-19)
COVID-19 medical device
means a medical device that is manufactured, sold or represented for use in relation to COVID-19. (instrument médical contre la COVID-19)
List of Medical Devices for an Urgent Public Health Need
means the List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux pour des besoins urgents en matière de santé publique)
List of Medical Devices for Expanded Use
means the List of Medical Devices for Expanded Use in Relation to COVID-19 that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux destinés à un usage élargi)
UPHN medical device
means any of the following medical devices for an urgent public health need related to COVID-19:
  • (a) a medical device that is set out in Part 1 of the List of Medical Devices for an Urgent Public Health Need;
  • (b) a medical device that belongs to a category of medical devices that is set out in Part 2 of the List of Medical Devices for an Urgent Public Health Need. (instrument médical BUSP)

Application

68.02 (1) This Part applies to medical devices that are not subject to Part 2 or 3.

(2) However, this Part does not apply to Class I medical devices that are not COVID-19 medical devices.

Authorization

Non-application of Part 1 — Importation and Sale

68.03 (1) Despite section 8, Part 1 does not apply in respect of the importation or sale of a COVID-19 medical device if the manufacturer of the device holds an authorization for the device.

(2) However, the following provisions of Part 1 apply in respect of the importation or sale of the COVID-19 medical device:

(3) Despite paragraph (2)(b), subsection 44(3) does not apply if the COVID-19 medical device that is imported is a Class I device and the person from whom the device is imported is the manufacturer.

Deemed Authorization

68.04 Sections 68.05 to 68.09 apply to COVID-19 medical devices.

68.05 In sections 68.06 to 68.09, authorized, in relation to a medical device, means that the device is the subject of an authorization.

68.06 If a system is authorized, all of its components or parts that are manufactured by the manufacturer of the system are deemed, for the purposes of its importation, sale or advertisement, to be authorized.

68.07 If a test kit is authorized, all of its reagents or articles that are manufactured by the manufacturer of the test kit are deemed, for the purposes of its importation, sale or advertisement, to be authorized.

68.08 If a medical device or medical device group is authorized and forms part of a medical device family or medical device group family, as the case may be, all other medical devices or medical device groups in the family are deemed to be authorized.

68.09 (1) If all the medical devices that form part of a medical device group are authorized, that medical device group is deemed to be authorized.

(2) If a medical device group is authorized, all the medical devices that form part of the medical device group are deemed, for the purposes of its importation, sale or advertisement, to be authorized.

Application for an Authorization

68.1 (1) The Minister may add a medical device to Part 1 of the List of Medical Devices for an Urgent Public Health Need only if the Minister has reasonable grounds to believe that there is an urgent public health need related to COVID-19 for the device.

(2) The Minister may add a category of medical devices to Part 2 of the List of Medical Devices for an Urgent Public Health Need only if the Minister has reasonable grounds to believe that there is an urgent public health need related to COVID-19 for the devices that belong to that category.

68.11 (1) A manufacturer of a COVID-19 medical device may submit to the Minister an application for an authorization for the device if it is a UPHN medical device.

(2) The application shall be submitted in a form established by the Minister. The application shall contain sufficient information and documents to enable the Minister to determine whether to issue the authorization, including

(3) An application in respect of a Class III or IV COVID-19 medical device shall contain, in addition to the information and documents referred to in subsection (2),

(4) Despite subsection (2) and subsection (3), the application need not include the information and documents referred to in paragraphs (2)(g) and (h) and, if applicable, subsection (3) if

Issuance

68.12 The Minister shall issue an authorization for a COVID-19 medical device if the following requirements are met:

Amendment

68.13 No person shall import or sell a COVID-19 medical device for which the manufacturer holds an authorization if the device has been the subject of any of the following changes unless the manufacturer holds an amended authorization:

68.14 An application to amend an authorization shall be submitted to the Minister by the holder of the authorization in a form established by the Minister. The application shall contain sufficient information and documents to enable the Minister to determine whether to amend the authorization, including the information and documents referred to in subsection 68.11(2) and (3) that relate to the change referred to in section 68.13 for which an amendment to the authorization is required.

68.15 The Minister shall amend an authorization for a COVID-19 medical device if the following requirements are met:

Refusal

68.16 The Minister may refuse to issue or amend an authorization for a COVID-19 medical device if

68.17 The Minister shall refuse to amend an authorization for a COVID-19 medical device in the case where the application to amend the authorization indicates that the holder of the authorization intends, if the authorization were to be amended, that the device would not be manufactured, sold or represented for use in relation to COVID-19.

68.18 If the Minister refuses to issue or amend an authorization, the Minister shall notify the manufacturer of the COVID-19 medical device in writing of the reasons for the refusal and give them an opportunity to be heard.

Terms and Conditions

68.19 The Minister may, at any time, impose terms and conditions on an authorization for a COVID-19 medical device or amend those terms and conditions.

Applications Submitted Under Part 1

68.2 Despite section 68.03, the holder of an authorization for a COVID-19 medical device may submit

Cancellation

68.21 (1) The Minister may cancel an authorization for a COVID-19 medical device by written notice to the holder, giving reasons, if

(2) A ground for cancellation specified in subparagraph (1)(i)(i) or (j)(i) does not apply if the holder has already provided the Minister with a copy of the quality management system certificate referred to in paragraph 32(2)(f), (3)(j) or (4)(p), as the case may be, or a copy of the contract referred to in the applicable subparagraph.

(3) A ground for cancellation specified in subparagraph (1)(i)(ii) or (j)(ii) does not apply if the holder has already provided the Minister with a copy of the quality management system certificate referred to in paragraph 32(2)(f), (3)(j) or (4)(p), as the case may be.

68.22 An authorization for a COVID-19 medical device is cancelled if

Additional Information and Material

68.23 The Minister may request that the manufacturer of a COVID-19 medical device who has submitted an application for an authorization or the holder of an authorization submit to the Minister, within a specified time limit, any additional information or documents or any material, including samples, that is necessary to enable the Minister to determine whether to issue, amend or cancel the authorization.

Annual Review

68.24 The holder of an authorization for a Class II, III or IV COVID-19 medical device that is not a UPHN medical device shall, annually before November 1 and in a form established by the Minister, provide the Minister with a statement signed by the holder or a person authorized to sign on the holder’s behalf

Discontinuance

68.25 If the holder of an authorization for a COVID-19 medical device discontinues the sale of the device in Canada, the holder shall inform the Minister within 30 days after the discontinuance.

Importation — Copy of Authorization

68.26 If the manufacturer of a COVID-19 medical device holds an authorization for the device, a person who imports a shipment of the device shall ensure that the shipment is accompanied by a copy of the authorization.

Incident Reporting

68.27 (1) The holder of an authorization for a COVID-19 medical device shall submit a preliminary report to the Minister in respect of any incident that comes to their attention occurring in Canada that involves the device

(2) The preliminary report shall contain the following information:

68.28 (1) The holder of the authorization shall, after making the preliminary report, submit a final report to the Minister in accordance with the timetable established under paragraph 68.27(2)(h).

(2) The final report shall contain the following information:

68.29 The holder of the authorization is not required to submit the preliminary report referred to in section 68.27 or the final report referred to in section 68.28 if

Serious Risk of Injury to Human Health

68.3 (1) The holder of an authorization for a Class II, III or IV COVID-19 medical device that is not a UPHN medical device shall submit to the Minister information in respect of any serious risk of injury to human health that the holder receives or becomes aware of and that is relevant to the safety of the device, regarding

(2) The information shall be submitted to the Minister within 72 hours after the holder receives or becomes aware of it, whichever occurs first.

(3) The holder is not required to provide the information if

Summary Report

68.31 (1) The holder of an authorization for a Class II, III or IV COVID-19 medical device that is not a UPHN medical device shall prepare

(2) The information to be covered by the summary report is that in respect of

(3) The summary report shall contain a concise critical analysis of the information referred to in subsection (2).

(4) In preparing the summary report, the holder shall determine, on the basis of the critical analysis, whether what is known about the benefits and risks associated with the COVID-19 medical device has changed in any of the following ways:

(5) The holder shall include the conclusions they reach under subsection (4) in the summary report.

(6) If, in preparing the summary report, the holder concludes that what is known about the benefits and risks associated with the COVID-19 medical device has changed in any of the ways referred to in paragraphs (4)(a) to (c), they shall notify the Minister, in writing, within 72 hours after having reached the conclusion, unless that has already been done.

68.32 (1) The Minister may, for the purposes of determining whether there is sufficient evidence to support the conclusion that the benefits associated with a COVID-19 medical device outweigh the risks, request that the holder of an authorization for the device submit, within a specified time limit, any of the following:

(2) The holder shall submit to the Minister the summary reports or information, or both, that the Minister requests within the time limit specified in the request.

68.33 (1) The holder of an authorization for a COVID-19 medical device shall maintain records of the summary reports and the information on the basis of which those reports were prepared.

(2) The holder shall retain the records for seven years after the day on which they were created.

Obligation to Submit Certificate

68.34 (1) If a new or modified quality management system certificate is issued in respect of a COVID-19 medical device for which the manufacturer of the device holds an authorization and that is not a UPHN medical device, the manufacturer shall submit a copy of the certificate to the Minister within 30 days after it is issued.

(2) Subsection (1) does not apply if the manufacturer includes the new or modified quality management system certificate in an application to amend the authorization that is submitted under section 68.14.

Sale — Cancellation of Authorization

68.35 Subject to sections 21, 23 and 44, if an authorization for a COVID-19 medical device is cancelled under paragraph 68.21(1)(h), (i) or (j), a person other than the manufacturer of the device may sell the device, despite any other provision in Part 1, for a period of six months beginning on the day on which the authorization is cancelled.

Expanded Use

68.36 (1) The Minister may add a licensed medical device or a Class II, III or IV COVID-19 medical device for which the manufacturer of the device holds an authorization to column 1 of the List of Medical Devices for Expanded Use and an expanded use to column 2 only if the following conditions are met:

(2) In the case of a licensed medical device, sections 26 and 27, as they relate to an expanded use of the device, do not apply in respect of the importation, sale or advertisement of the device if

(3) In the case of a Class II, III or IV COVID-19 medical device for which the manufacturer of the device holds an authorization, sections 27 and 68.13, as they relate to an expanded use of the device, do not apply in respect of the importation, sale or advertisement of the device if

68.37 The Minister shall publish on the Government of Canada website supplementary information pertaining to the expanded use, set out in column 2 of the List of Medical Devices for Expanded Use, of a licensed medical device — or a Class II, III or IV COVID-19 medical device for which the manufacturer of the device holds an authorization — set out in column 1 of that List, including

68.38 (1) The Minister may request from the holder of a medical device licence, in respect of the medical device set out in column 1 of the List of Medical Devices for Expanded Use for which the licence was issued, any information in relation to the expanded use set out in column 2 of that List that the holder possesses or to which they have reasonable access.

(2) The Minister may request from the holder of an authorization, in respect of the Class II, III or IV COVID-19 medical device set out in column 1 of the List of Medical Devices for Expanded Use for which the authorization was issued, any information in relation to the expanded use set out in column 2 of that List that the holder possesses or to which they have reasonable access.

(3) The holder of the licence or authorization shall submit to the Minister the information that the Minister requests within the time limit specified in the request.

8 Subparagraph 71(2)(f)(iii) of the Regulations is replaced by the following:

9 Subsection 72(1) of the Regulations is amended by striking out “and” at the end of paragraph (c) and by replacing paragraph (d) with the following:

Transitional Provisions

10 (1) In sections 11 to 19, Interim Order No. 3 means Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, made by the Minister on February 21, 2022 and published in the Canada Gazette, Part I, on March 12, 2022.

(2) Unless the context requires otherwise, words and expressions used in sections 11 to 19 have the same meaning as in the Medical Devices Regulations.

(3) For the purposes of sections 11 to 19, a reference to “instrument médical destiné à être utilisé à l’égard de la COVID-19” in the French version of Interim Order No. 3 and the List of Medical Devices for Expanded Use in Relation to the COVID-19 Pandemic shall be read as “instrument médical contre la COVID-19”.

11 Despite subsection 68.11(1) of the Medical Devices Regulations, an application for an authorization for importation or sale of a COVID-19 medical device that was submitted to the Minister under Interim Order No. 3 before the day on which these Regulations come into force and in respect of which no decision has been made before that day is deemed to be an application for an authorization submitted under section 68.11 of the Medical Devices Regulations.

12 (1) An authorization for importation or sale of a COVID-19 medical device that was issued by the Minister under Interim Order No. 3 before the day on which these Regulations come into force and has not been cancelled before that day is deemed to be an authorization issued under section 68.12 of the Medical Devices Regulations.

(2) Any terms and conditions of an authorization for importation or sale referred to in subsection (1) are deemed to have been imposed by the Minister under section 68.19 of the Medical Devices Regulations on the other authorization referred to in that subsection.

13 A COVID-19 medical device for which the manufacturer of the device holds an authorization and that is not labelled in accordance with subsection 21(2) of the Medical Devices Regulations in the six-month period that begins on the day on which these Regulations come into force the device may, despite that subsection, be sold during that period.

14 Section 68.35 of the Medical Devices Regulations shall be read without reference to subsection 21(2) of those Regulations in regard to any portion of the period referred to in that section that falls within the period referred to in section 13.

15 An application to amend an authorization for importation or sale of a COVID-19 medical device that was submitted to the Minister under Interim Order No. 3 before the day on which these Regulations come into force and in respect of which no decision has been made before that day is deemed to be an application to amend an authorization submitted under section 68.14 of the Medical Devices Regulations.

16 An authorization for importation or sale of a COVID-19 medical device that was amended by the Minister under Interim Order No. 3 before the day on which these Regulations come into force and has not been cancelled before that day is deemed to be an authorization that is amended to the same extent under section 68.15 of the Medical Devices Regulations.

17 A request that was made by the Minister under Interim Order No. 3 before the day on which these Regulations come into force for additional information or material, including samples, is deemed to be a request for additional information or material under section 68.23 of the Medical Devices Regulations.

18 (1) In the case of a COVID-19 medical device that is not a UPHN medical device on the day on which these Regulations come into force, a reference in subparagraphs 68.21(1)(h)(i), (i)(i) and (ii) and (j)(i) and (ii) of the Medical Devices Regulations to “the device ceases to be a UPHN medical device” shall be read as “the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) come into force”.

(2) Subsection (1) ceases to apply in respect of a COVID-19 medical device referred to in that subsection if the device becomes a UPHN medical device.

19 A request that was made by the Minister under Interim Order No. 3 before the day on which these Regulations come into force for information in relation to the expanded use of a COVID-19 medical device or another medical device set out in the List of Medical Devices for Expanded Use in Relation to the COVID-19 Pandemic, referred to in the definition List of Medical Devices for Expanded Use in subsection 1(1) of the Interim Order, is deemed to be a request for information in relation to the expanded use under subsection 68.38(1) or (2) of the Medical Devices Regulations, as the case may be.

Coming into Force

20 These Regulations come into force on the day after the day on which Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, made by the Minister on February 21, 2022 and published in the Canada Gazette, Part I, on March 12, 2022, ceases to have effect, but if they are registered after that day, they come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues: Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (the third interim order) is set to expire on February 21, 2023. Upon expiry of the interim order, all authorizations (over 800 COVID-19 medical devices) issued under it will expire. As COVID-19 remains a public health issue, unless regulations are put in place to address this gap, critical access to COVID-19 medical devices for Canadians may be interrupted or delayed.

Description: The Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) [the Regulations] introduce amendments to the Medical Devices Regulations (MDR) to create a permanent regulatory framework for COVID-19 medical devices, while maintaining many of the flexibilities provided under the third interim order. The amendments will create a new Part 1.1 in the MDR and will also introduce consequential changes to Parts 1 and 2 of the MDR.

Rationale: The Regulations will continue accelerated access to COVID-19 medical devices for which there is an urgent public health need in Canada without relying on temporary regulatory measures. The Regulations will also maintain interim order authorizations, and therefore enable manufacturers, importers and distributors to continue to import or sell COVID-19 devices authorized under the third interim order. Amending the MDR will provide predictability and stability to Health Canada as a regulator as well as to manufacturers, importers and distributors of COVID-19 medical devices. The Regulations will be less burdensome to businesses and the Government by maintaining authorizations for these medical devices as compared to reapplication under Part 1 of the MDR. While new applications under Part 1.1 will benefit from some savings, incremental costs may result if the new COVID-19 medical devices are authorized with terms and conditions.

Issues

From the outset, the COVID-19 pandemic created challenges in global supply chains, including an unprecedented demand for certain medical devices.

To provide more timely access to medical devices used in the diagnosis, treatment, mitigation, or prevention of COVID-19, the Government of Canada made three consecutive interim orders respecting the importation and sale of medical devices for use in relation to COVID-19. Interim orders are emergency measures and are intended to be temporary. The latest interim order — being the third interim order — is set to expire on February 21, 2023.

Expiration of the third interim order without a plan to transition its flexibilities and active authorizations into the MDR would result in

As COVID-19 remains a public health issue, the MDR are being amended to provide a permanent regulatory framework for COVID-19 medical devices and to maintain many of the flexibilities introduced by the medical devices interim orders. The Regulations will continue accelerated access to COVID-19 medical devices for which there is an urgent public health need in Canada without relying on temporary regulatory measures.

Background

Government of Canada’s response to the COVID-19 pandemic

Since March 2020, the Government of Canada has made three consecutive medical devices interim orders to provide a faster way to authorize the importation and sale in Canada of medical devices that are used to diagnose, treat, mitigate or prevent COVID-19:

Through the interim orders, Health Canada has authorized over 800 COVID-19 medical devices, including COVID-19 diagnostic test kits (e.g. rapid test kits and serological test kits) and other important non-testing medical devices (e.g. personal protective equipment, syringes and ventilators).

Authorizations have been issued to a mix of domestic and international manufacturers. The emergency measures have allowed Canadians to have expedited access to safe and effective COVID-19 medical devices.

Mechanisms under the third interim order

Under the third interim order, medical devices are classified into four classes of risk as per the classification rules set out in Schedule 1 of the MDR, where Class I represents the lowest risk (e.g. medical gowns) and Class IV represents the highest risk (e.g. SARS-CoV-2 testing devices).

There are three authorization mechanisms under the third interim order:

The third interim order allows the Minister of Health (the Minister) to use discretion in determining the level of evidence required to demonstrate the safety and effectiveness of the devices authorized to meet an urgent public health need. The Minister also has the ability, at any time, to

Similar to Part 1 of the MDR, the third interim order requires all importers and distributors to hold a medical device establishment licence (MDEL) and meet the requirements set out in Part 1 of the MDR for MDEL holders as they relate to recalls, complaints, incident reporting, and distribution records and procedures.

Also, manufacturers, importers and distributors of all COVID-19 medical devices authorized under the third interim order must comply with labelling provisions similar to those prescribed in the MDR.

The requirement for manufacturers of Class II to IV medical devices to have a quality management system (QMS) certificate is waived under the third interim order and the Minister uses flexibility in the level of evidence required to demonstrate the quality of a COVID-19 medical device.

Objective

The objectives of the Regulations are to

Description

There are two elements to this regulatory package:

Part 1.1 of the MDR will

Part 1.1 of the MDR will largely align with provisions from the third interim order and will be an alternate pathway for COVID-19 medical devices that is complementary to the medical device licensing pathway under Part 1 of the MDR.

The amendments to Part 1 of the MDR comprise consequential amendments to the provisions related to advertising, serious risk of injury to human health, summary reporting and shortages. The amendments to Part 2 of the MDR comprise consequential amendments to the special access provisions.

Medical Devices for Use in Relation to COVID-19 (Part 1.1)

1. Maintaining all active interim order authorizations and expanded use indications

Through the Regulations, all Class I, II, III and IV medical device interim order authorizations from the third interim order will become authorizations under Part 1.1 of the MDR when the Regulations come into force. Existing expanded use indications permitted under the third interim order will remain in place as well.

The Regulations will also carry over applications that are in queue from the third interim order; however, these applications will be reviewed against criteria established under Part 1.1 of the MDR, and not the criteria from the third interim order.

All outstanding terms and conditions previously imposed on interim order authorizations and all requests for information or materials made by the Minister before the coming into force of the Regulations will continue to apply when the authorized COVID-19 medical devices transition into Part 1.1 of the MDR.

2. Urgent public health need

Under Part 1.1 of the MDR, Health Canada will publish a List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 (UPHN list), which will be incorporated by reference in the Regulations and amended from time to time.

The Minister will add a medical device to Part 1 of the UPHN list or a category of medical devices to Part 2 of the UPHN list only if there are reasonable grounds to believe that there is an urgent public health need related to COVID-19 for the medical device or for devices that belong to the category.

The Minister could consider various factors in that context, such as

3. Flexibilities

Authorization holders under Part 1.1 of the MDR (either from the third interim order, or newly authorized) will be subject to many of the same flexibilities available under the third interim order (e.g. exemptions from MDEL, QMS certificate and fee requirements) as long as their medical device is on the UPHN list.

Once the COVID-19 medical device is no longer on the UPHN list, authorization holders will need to comply with certain requirements that are met by other licensed medical device holders in Canada to continue to import or sell the medical device.

For authorization holders that have an authorization under the third interim order, whose medical device is not on the UPHN list upon the coming into force of the Regulations, the additional requirements will be triggered immediately (see sections 6 and 7 below for the additional requirements).

4. Permanent COVID-19 authorization pathway

The Regulations will introduce a permanent authorization pathway under Part 1.1, which will retain the same three authorization mechanisms provided in the third interim order for new COVID-19 medical devices.

The Minister will be able to issue under Part 1.1 of the MDR

For authorizations based on an approval by a regulatory agency, a List of Regulatory Agencies for the Purposes of Subsection 68.11(4) of the Medical Devices Regulations will be incorporated by reference. The list will include foreign jurisdictions and foreign regulatory authorities that have established application requirements and standards for authorization that meet those established in Part 1.1 of the MDR. This list will be amended from time to time.

4.1 Application requirements

The permanent COVID-19 authorization pathway will set out similar application requirements as the third interim order. However, certain language in the application requirement provisions will be amended to align with language in Part 1 of the MDR. The Regulations will also now require that applications include evidence from the manufacturer that a QMS is in place. For applications based on an authorization or licence issued by a regulatory agency, similar to the third interim order, applicants may omit certain information in their application if they provide evidence that their COVID-19 medical device has been granted market approval by a regulatory agency; however, the regulatory agency would need to be on the List of Regulatory Agencies for the Purposes of Subsection 68.11(4) of the Medical Devices Regulations.

4.2 Issuance

As is the case under the third interim order, the Minister will only issue an authorization for a new COVID-19 medical device to a manufacturer if there is an urgent public health need. As well, the evidence needs to support that the benefits outweigh the risks associated with the device, while considering the uncertainties related to the benefits and risks. The Regulations also introduce a new issuance criteria relating to evidence that the manufacturer has an adequate QMS in place that ensures that the COVID-19 medical device meets its specifications. This new issuance criteria will align with the updated quality management evidence application requirement described above.

4.3 Amendment

As is the case under the third interim order, authorization holders will be able to submit an application to amend an authorization. However, the Regulations will further specify the types of changes that require an amendment, which will align with the types of changes that trigger an amendment for licensed medical devices in Part 1 of the MDR.

4.4 Refusal

Although the Minister has the authority to refuse to authorize a medical device under the third interim order, refusal authorities are currently not explicit. The Regulations will specify when the Minister may refuse to issue or amend an authorization. These refusal authorities will align with the ones found in Part 1 of the MDR (e.g. refusal based on non-compliance with the Regulations or Act; non-compliance with labelling provisions; or non-compliance with information, document or material requests).

Specific to Part 1.1 of the MDR, the Minister will also now be required to refuse to amend an authorization if information in the amendment application indicates that the manufacturer intends to change the purpose of the medical device to make it unrelated to COVID-19.

5. Regulatory obligations under Part 1.1 for authorization holders and modifications from the third interim order
5.1 Labelling requirements

Authorization holders will need to meet labelling requirements in the MDR, specifically section 21 and section 23. These requirements are similar to provisions currently prescribed in the third interim order, but will require that labels be legible and easily understood by the intended user. Authorization holders that come from the third interim order will have a six-month period from the date the Regulations come into force to comply with the labelling requirements under the MDR, if they do not currently meet these requirements.

5.2 Post-market requirements

Authorization holders will also need to meet post-market requirements related to distribution records, complaint handling and recalls. These post-market requirements are identical to requirements currently imposed on authorization holders under the third interim order, with the exception of complaint handling requirements. This change is being made to address a gap in the application section from the third interim order which currently requires documented procedures relating to complaint handling, but does not provide explicit complaint handling requirements.

In addition, the Regulations will also require authorization holders to report an incident to the Minister within 10 days after becoming aware of it, in cases where a death or serious deterioration has occurred. However, unlike the reporting requirements under the third interim order, the incident reporting period will change from 10 days to 30 days in cases where no death or serious decline in a patient’s health occurred but could, if the incident were to recur. These timelines for incident reporting will align with what is currently required in Part 1 for licensed medical devices. The Regulations will also specify that authorization holders must submit two reports, a preliminary and final report, for all types of incidents. This is currently articulated in guidance only under the third interim order.

To align with provisions under Part 1 of the MDR, the Regulations will also require authorization holders to inform the Minister if they choose to discontinue the sale of their authorized device in Canada, within 30 days of discontinuance.

Manufacturers of Class I to IV COVID-19 medical devices will also be required to report shortages of devices (including their components, accessories and parts) that are on the List of Medical Devices – Notification of Shortages.

5.3 Terms and conditions

Part 1.1 of the MDR will replicate the Minister’s authorities from the third interim order to impose or amend terms and conditions on all classes of COVID-19 medical devices at any time and authorization holders will be required to comply with them.

5.4 Requests for information and/or materials

As is the case under the third interim order, the Minister may request any additional information or documents or any material from applicants or authorization holders to determine whether to issue, amend or cancel an authorization under Part 1.1 of the MDR. The Regulations now provide the Minister with the authority to set a time limit within which the information, document or material must be submitted.

6. Additional requirements for Class I COVID-19 medical device manufacturers once the medical device is no longer on the UPHN list

As is the case under the third interim order, manufacturers of Class I COVID-19 medical devices that hold an authorization under Part 1.1 will continue to be exempt from the requirement to hold an MDEL. However, this exemption only applies until the medical device is no longer on the UPHN list. At that point, if the authorization holder wishes to continue selling or importing their Class I COVID-19 medical device in Canada, they will need to comply with Part 1 of the MDR.

The Class I COVID-19 medical device authorization holder will have 120 days after the day on which the COVID-19 medical device is no longer on the UPHN list to apply for an MDEL. During the application period and throughout the process of obtaining an MDEL, the authorization under Part 1.1 of the MDR will remain active.

In the case of a Class I COVID-19 medical device authorization holder that is transitioned from the interim order, whose medical device is not on the UPHN list when the Regulations come into force, the authorization holder will have 120 days after the day on which the Regulations come into force to apply for an MDEL, or to choose to import or distribute through an existing MDEL holder.

If the additional requirements are not met by the prescribed timelines, or the Minister refuses to issue an MDEL to the authorization holder, or the authorization holder chooses to withdraw their application, the authorization under Part 1.1 of the MDR may be cancelled by the Minister.

7. Additional requirements for Class II to IV COVID-19 medical device manufacturers once the medical device is no longer on the UPHN list

Manufacturers of Class II to IV COVID-19 medical devices can maintain their COVID-19 authorization under Part 1.1 of the MDR after their device is removed from the UPHN list by complying with the additional requirements outlined in this section.

These additional requirements are also triggered immediately upon the coming into force of the Regulations for authorization holders that transition from the interim order and whose medical devices are not on the UPHN list when the list first becomes published.

7.1 Quality management system certificate requirements

To remain authorized under Part 1.1 of the MDR after a Class II to IV COVID-19 medical device is no longer on the UPHN list, the authorization holder will need to

During the certification process, the authorization under Part 1.1 of the MDR will remain active.

These authorization holders will also be required to provide the Minister a copy of any updated certificates (e.g. if a new or modified QMS certificate is issued) within 30 days after the new certificate is issued. This requirement aligns with requirements imposed on holders of licensed medical devices under Part 1 of the MDR.

7.2 Annual review

Authorization holders of Class II to IV COVID-19 medical devices will also be subject to annual renewal requirements if the holder wishes to continue importing and selling their medical device once it is no longer on the UPHN list. The annual renewal requirements will mirror licence renewal process requirements in Part 1 of the MDR. On an annual basis, before November 1, authorization holders of Class II to IV COVID-19 medical devices that are not on the UPHN list will be required to confirm that the information and documents submitted with their authorization application and any subsequent amendments are still correct, or to describe any changes to the information and documents to maintain their authorization.

7.3 Serious risk and biennial/annual summary report requirements

Class II to IV COVID-19 medical device authorization holders will also be subject to risk notification and biennial/annual summary requirements that are in line with requirements imposed on medical device licence holders under Part 1 of the MDR. Once a Class II to IV COVID-19 medical device is taken off the UPHN list, to continue to import or sell the medical device, the authorization holder will need to

8. Cancellation of COVID-19 authorizations

Part 1.1 of the MDR will maintain the Minister’s cancellation authorities from the third interim order. To strengthen the Minister’s post-market authorities, the Regulations also introduce new cancellation grounds that will allow a COVID-19 authorization to be cancelled if

An authorization will also be cancelled when

9. Regulatory obligations under Part 1.1 for importers and distributors and modifications from the third interim order
9.1 MDEL and post-market requirements

Under Part 1.1 of the MDR, importers and distributors of COVID-19 medical devices will need to meet post-market requirements relating to distribution records, incident reporting, complaint handling and recalls which are currently requirements under the third interim order. In addition, importers and distributors will need to continue to hold an MDEL and pay associated MDEL and annual renewal fees for as long as they hold an MDEL.

Importers of Class I COVID-19 medical devices will also be required to report shortages of devices (including their components, accessories and parts) that are on the List of Medical Devices – Notification of Shortages.

9.2 Importation requirements

Importers will be subject to the same importation requirements as prescribed in the third interim order, which will be carried over in the Regulations. Each shipment of a COVID-19 medical device that is imported into Canada will need to be accompanied by a copy of the authorization issued under Part 1.1 of the MDR.

9.3 Sale — Cancellation of authorization

An authorization under Part 1.1 of the MDR may be cancelled if the manufacturer does not apply for an MDEL (Class I) or meet QMS requirements (Class II to IV) within the prescribed timelines. If that occurs, the Regulations will no longer allow manufacturers to sell their medical devices. However, importers and distributors will be permitted an additional six-month period to continue to sell off existing stock as long as the existing stock complies with labelling requirements and the importers and distributors hold an active MDEL.

10. Regulatory obligations under Part 1.1 for hospitals

Section 62 requirements will apply to hospitals for the reporting of medical device incidents related to COVID-19 medical devices authorized under Part 1.1. Hospitals currently report incidents related to COVID-19 medical devices that are authorized under the third interim order.

Regulatory amendments to Part 1 and Part 2 of the MDR

In addition to the above, Parts 1 and 2 of the MDR will be amended consequentially for clarification in light of the new Part 1.1 provisions outlined above. The goal of these amendments is to ensure that all provisions of the MDR are in alignment.

1. Advertising (section 27 of Part 1 of the MDR)

As is the case under the third interim order, Health Canada will continue to allow the advertisement of all authorized COVID-19 medical devices for the purpose of sale. The regulatory amendments will amend the prohibition provision under section 27 of Part 1 of the MDR to permit this.

2. Serious risk of injury to human health (paragraph 61.2(2)(a) of Part 1 of the MDR)

The Regulations are adding to Part 1.1 risk notification requirements similar to those in section 61.2 of Part 1 for Class II to IV COVID-19 medical device authorization holders with medical devices that are removed from the UPHN list. Paragraph 61.2(2)(a) currently incorporates by reference the List of Regulatory Agencies for the Purposes of Section 61.2 of the Medical Devices Regulations. A similar list is required under Part 1.1. To avoid the duplication of lists for the purposes of serious risk reporting under Part 1 and Part 1.1, the Regulations will amend the title of the incorporated by reference list in paragraph 61.2(2)(a) and will include a reference to the new serious risk of injury provision in Part 1.1: section 68.3. This List will be titled List of Regulatory Agencies for the Purposes of Sections 61.2 and 68.3 of the Medical Devices Regulations.

3. Summary report (sections 61.4 to 61.6 of Part 1 of the MDR)

The Regulations will be amended to clarify the language found in the summary reporting provisions in Part 1. These changes will align with the language in Part 1.1 for consistency.

4. Shortages (paragraph 62.23(1)(b) and subsection 62.23(3) of Part 1 of the MDR)

Part 1 provisions related to shortages will be amended to apply to Part 1.1 authorizations. The amendments will allow the Minister to add a COVID-19 medical device to the List of Medical Devices – Notification of Shortages if the Minister has reasonable grounds to believe that a shortage of that device presents, or may present, a risk of injury to human health. With these changes, Health Canada will have more effective oversight of the Canadian supply of these devices and will be able to act more quickly to address risks posed by a shortage.

5. Special Access Program applications (subparagraph 71(2)(f)(iii) and subsection 72(1) of Part 2 of the MDR)

The Regulations will amend Part 2 of the MDR to ensure that applicants for the Special Access Program also consider COVID-19 medical devices that are available in Canada prior to applying for an authorization under Part 2 of the MDR.

Coming into force

The Regulations will come into force the day after the day on which the third interim order ceases to have effect.

Regulatory development

Consultation

November 2020 – January 2021 (targeted email consultation)

In 2020, Health Canada communicated to stakeholders a plan to bring forward stand-alone transition regulations that would replace the second interim order and be in effect for two years. With the emergence of the Omicron variant at the end of 2021, Health Canada decided to instead proceed with a third interim order.

As part of this previous transition plan, Health Canada conducted a targeted email consultation with over 9 000 stakeholders between November 2020 and January 2021 to seek feedback on the regulatory approach for the second interim order and the initial transition regulations, as well as the potential costs.

The targeted email consultation was sent to

Health Canada received 72 stakeholder responses from this consultation.

Some stakeholders gave specific reasons for their support of the first interim order, such as reduced barriers; reduced time to market; reduced costs; simplicity of application process; and flexible scientific requirements. These flexibilities from the first interim order were carried over into the second and third interim orders, and will continue into these Regulations as well.

The stakeholder feedback indicated that the 10-day reporting timelines were not long enough to allow the manufacturer to do any investigation. Based on this feedback, the incident reporting period for non-serious incidents under Part 1.1 of the MDR was changed from 10 days to 30 days to align with Part 1 of the MDR. This change will enable authorization holders to complete more thorough investigations of non-serious incidents. The 30-day timeline may also allow for further investigation, saving resources for authorization holders as well as Health Canada.

Generally, respondents cited their support for the proposed 2020–2021 transition policy at the time. A very small number of stakeholders expressed concerns about additional requirements, under the previously proposed transition policy, which would have aligned with the Part 1 MDR requirements, including extra processes, procedures and record keeping.

Some stakeholders also identified the previously proposed transition regulations’ requirement to obtain a QMS certificate by the end of the transition period as challenging due to the costs and process. Health Canada is again maintaining the requirement to obtain a QMS certificate in these Regulations despite the concerns identified by the stakeholders in the 2020–2021 consultation. Obtaining a QMS certificate creates a reliable standard, ensures an appropriate level of quality for Class II, III and IV medical devices and normalizes the requirements with Part 1 of the MDR. However, in these Regulations, the two-year process to obtain a QMS certificate will begin when the device is no longer on the UPHN list, instead of by the end of a predetermined two-year transition period. Or, in the case of authorization holders coming from the third interim order, whose medical devices are not on the UPHN list when the Regulations come into force, a two-year period from the coming-into-force date.

May 2022 (Notice of Intent)

A Notice of Intent on the proposed regulatory amendments to the MDR to continue the sale and importation of COVID-19 medical devices was posted on May 2, 2022, for public consultation. It outlined the revised approach to continue the importation and sale of COVID-19 medical devices after the interim order expires. The consultation was open for 21 days and closed on May 22, 2022.

Health Canada sought comments from medical device stakeholders, including MDEL and authorization holders under the third interim order, and received six responses.

Half of the responses received related to the scope of the amendments. The other half of the feedback pertained to input beyond the scope of the amendments that related to specific individual interim order applications as well as a general question about the interim order. Regarding the feedback received about the scope of the amendments, stakeholders primarily sought clarifications (e.g. implementation details related to the proposed annual authorization requirements and process related to amendment applications and QMS certificates), but no concerns were raised.

Stakeholders also advocated for

In addition to the Notice of Intent, Health Canada also consulted with Medtech Canada, a key medical device stakeholder association. Overall, the proposed regulatory amendments were well received and supported. As well, Health Canada informed provincial and territorial partners through the Public Health Agency of Canada (PHAC) Logistics Advisory Committee about the updated approach. No concerns were raised.

Additional consultation measures

In addition to the consultations outlined above, Health Canada is also taking measures to keep partners, such as PHAC, provinces, territories and other federal government departments, informed of any issues or concerns that arise. Health Canada is holding these discussions as part of routine communications and meetings between Health Canada and these organizations.

Exemption from prepublication

Health Canada sought an exemption from prepublication in the Canada Gazette, Part I, for the Regulations. An exemption will provide for a seamless transition, timely normalization, and clarity and predictability to medical device manufacturers, importers and distributors, and the health care system in relation to COVID-19 medical devices before the expiry of the third interim order. Without the Regulations or a new interim order, all authorizations for medical devices issued under the third interim order would no longer be valid and the importation and sale of these devices would be prohibited. The Regulations will contribute to ensuring continuity without relying on temporary regulatory measures like another interim order. The Regulations will also allow Health Canada to have continued oversight for authorizations issued under the third interim order and make available the same authorization pathways for new COVID-19 medical devices and expanded use indications. This will enable the Government to address any new urgent public health needs related to COVID-19, while maintaining safety, effectiveness and quality.

The Regulations will also be largely aligned with the provisions from the third interim order. Any policy changes or new policies will align with elements of Part 1 of the MDR to ensure appropriate long-term oversight of the authorized COVID-19 medical devices. Stakeholders were consulted on the approach and there was general support. The burden placed on stakeholders has been minimized to the extent possible by carrying over many of the flexibilities and processes of the interim orders.

Modern treaty obligations and Indigenous engagement and consultation

As required by the Cabinet Directive on the Federal Approach to Modern Treaty Implementation, an assessment of modern treaty implications was conducted on the Regulations. The assessment did not identify any modern treaty implications or obligations.

Instrument choice

Health Canada considered the following regulatory and non-regulatory options:

Option 1: Status quo

If Health Canada allowed the third interim order to expire without putting in place additional regulatory measures, all COVID-19 medical devices authorized under the interim order would no longer be authorized after the expiry. Those devices could only be imported and sold in Canada if a manufacturer or importer obtained a medical device licence or MDEL, depending on the device class. This could take up to two years, which could cause significant difficulty in meeting Canada’s COVID-19 medical device needs.

For this reason, the status quo option was not deemed adequate to address the objectives given that COVID-19 is still a risk to public health at this time.

Option 2: Interim order

The Food and Drugs Act includes the authority for a fourth interim order to be made if the threshold for making an order is met when the third interim order expires. However, as an interim order is only valid for up to one year, it would not provide stability or predictability to Health Canada and stakeholders in managing the supply of COVID-19 medical devices.

For this reason, the interim order option was not deemed adequate to address the objectives, given the need to enable manufacturers, importers and distributors to continue to import and sell their interim order-authorized devices for a longer term through a stable and predictable mechanism.

Option 3: Amendments to the MDR

Under this selected option, Health Canada amended the MDR to include a regulatory framework that is similar to what is outlined in the interim orders. The Regulations will allow for the continued importation and sale of COVID-19 medical devices while also permanently maintaining a COVID-19 authorization pathway consistent with the third interim order. This will enable the Government to address any new urgent public health needs related to COVID-19, while maintaining safety, effectiveness and quality. It will also provide predictability and stability to Health Canada as a regulator as well as to manufacturers, importers and distributors.

When a COVID-19 medical device is no longer on the UPHN list, the Regulations will provide authorization holders with sufficient time to meet certain additional requirements that must also be met by other medical devices approved in Canada (e.g. hold an MDEL, obtain a QMS certificate) should they choose to retain their authorization.

Regulatory analysis

Benefits and costs

The cost-benefit analysis (CBA) aims to inform major stakeholders (including businesses, consumers and Health Canada) of the impacts of the Regulations. This CBA is based on the following:

Baseline scenario

In the baseline scenario, businesses that have a valid authorization issued under the third interim order would no longer be able to continue selling these COVID-19 medical devices when the interim order expires on February 21, 2023. Thus, the baseline used for the analysis is that businesses that have authorizations under the third interim order would have to meet the requirements of Part 1 of the MDR to continue selling their products.

Policy scenario

The Regulations will effectively extend most provisions of the third interim order for COVID-19 medical devices that are on the UPHN list, which will be incorporated by reference in Part 1.1 of the MDR. Ongoing market participation under the Regulations will be optional. The authorization holders of the devices will decide if they want to make their medical devices compliant with Part 1, Part 1.1 or leave the Canadian market. Class I device manufacturers who wish to continue on the market upon removal from the UPHN list will be subject to MDEL requirements in Part 1 of the MDR. For Class II to IV COVID-19 medical devices that are no longer on the UPHN list, the Regulations will provide businesses sufficient time to comply with the additional requirements described in Part 1.1 of the MDR if they choose to keep their COVID-19 authorization. For authorization holders of devices that choose to leave the Canadian market, importers and distributors will have a six-month sell-off period to deplete existing stock once the authorization is cancelled.

The Regulations will continue to provide the three authorization mechanisms from the third interim order to expedite authorization of new COVID-19 medical devices on the UPHN list, to issue new expanded use indications in the future and to authorize new COVID-19 medical devices for an urgent public health need based on the authorization of another trusted regulatory agency. The Regulations will not impose post-market summary biennial/annual reporting while a device is listed on the UPHN list.

The following summary presents considerations for industry stakeholders, Health Canada and Canadians.

Costs
I. Industry

To meet market demand given the public health emergency, some COVID-19 medical devices were subject to terms and conditions under the interim order, which varied in complexity across the four classes of medical devices. For the purposes of the cost-benefit analysis, terms and conditions for Class II to IV medical devices are acknowledged qualitatively, given that manufacturers can choose the least cost pathway between Part 1 or Part 1.1footnote 5 and Health Canada has no certainty of the number or breadth of terms and conditions to be issued under the Regulations. Class I medical devices are not subject to terms and conditions under the baseline and, thus, may also incur incremental costs under the Regulations.

II. Government

In the policy scenario, effort may be required to manage unresolved terms and conditions for medical devices on the UPHN list. It is assumed that the cost to review the terms and conditions for testing and evaluation of Class I medical devices is approximately $1,500footnote 6 over the next few years. There is high variability in review times depending upon the specific terms and conditions that may be imposed.

It is anticipated that the Department would incur expenses in compliance and enforcement actions including resources dedicated to incident reports, recalls, compliance verifications and inspections for products that will remain on the Canadian market after the expiration of the third interim order.footnote 7 Health Canada may also be implicated in seizing and destroying medical devices that come off the UPHN list but remain on the market past the sell-off period; however, these cases are expected to be rare. The total estimated cost to government for compliance and enforcement actions as a result of the Regulations is estimated at approximately $42,000 per year. These costs will be absorbed by Health Canada using existing resources.

Benefits

The Regulations maintain many of the flexibilities introduced in the interim orders. They also provide a permanent framework for COVID-19 medical devices within the MDR to allow vital medical devices to be available in the future. Without the Regulations, these medical devices authorized under the interim orders could not be imported and sold in Canada until a manufacturer of a Class I device either obtains an MDEL or imports through an existing MDEL holder, or a manufacturer of a Class II, III or IV medical device obtains a medical device licence, which may result in product shortages on the Canadian market. The flexibilities provided in the Regulations will allow products to remain available on the Canadian market and will result in savings to industry stakeholders, convenience and a wider range of medical devices being available to consumers.

I. Industry

CBA survey respondents contacted in 2020–2021 indicated broad support for the creation of a mechanism to see their authorizations extended beyond the interim order. Many businesses used the interim orders to bring their COVID-19 medical devices to Canada, which allowed them to gain knowledge and experience on the Canadian market.

New applicants seeking authorizations under Part 1.1 of the MDR will benefit in the same way. Businesses with devices on the UPHN list will not be required to submit post-market summary reports or meet annual review requirements, which will reduce administrative burden as long as their devices remain on the UPHN list. Ultimately the Regulations allow companies with existing COVID-19 authorizations to defer expenses normally associated with the MDR until such time as their product is removed from the UPHN list. New market entrants eligible under the Regulations receive similar benefits.

The Regulations may also benefit businesses with products already approved by other jurisdictions as long as an urgent public health need exists with respect to COVID-19. The recognition of approvals by trusted regulatory agencies from other jurisdictions is expected to result in cost savings for established foreign manufacturers or local importers to introduce products to the Canadian market.

II. Government

It is assumed that, over time, the management of the UPHN list will see a gradual move towards the normal course of business for Health Canada staff. The Regulations will enable the Department to focus its resources on new applications for authorization rather than on the reauthorization of medical devices already authorized under the third interim order. Compliance and enforcement oversight is expected to improve over time, as the requirements in Part 1.1 are similar to those in Part 1 of the MDR.

III. Canadians

Canadian patients and consumers rely on Health Canada to support the safe and effective supply of COVID-19 medical devices. The Regulations maintain the authorizations of specified COVID-19 medical devices, which facilitates ongoing access to important devices needed by Canadians. Furthermore, compliance requirements introduced under the Regulations will help ensure that COVID-19 medical devices remain safe and available to Canadians when needed for their care.

Small business lens

Seventy percent of Canadian businesses that responded to the 2020–2021 CBA survey consultation indicated that they met the definition of a small business. It is anticipated that many small businesses will benefit from the Regulations. Class I to IV authorization holders from the third interim order are not required to reapply to continue selling their products while on the UPHN list. Class II to IV authorization holders also have the choice to maintain their authorizations if certain requirements are met, should their product be removed from the UPHN list. Small businesses will also face reduced administrative burden from provisions exempting post-market reporting for authorized products on the UPHN list.

The interim orders have provided these small businesses an opportunity to gain knowledge and experience of the Canadian market which they otherwise would not have had, supporting their decision to continue on or leave the Canadian market. For authorization holders of COVID-19 medical devices that are no longer on the UPHN list, the Regulations will provide a benefit by allowing a 120-day period for Class I manufacturers to apply for an MDEL or 120 days for Class II to IV manufacturers to submit a copy of the certification contract to demonstrate that they have begun the QMS certification process. Manufacturers who choose not to comply with these additional requirements may have their authorizations cancelled, while importers and distributors will have a six-month sell-off period to deplete any existing stock to reduce business losses.

One-for-one rule

The one-for-one rule applies since there is an incremental decrease in administrative burden on business, and the Regulations are considered a burden out under the rule.

Authorization holders of Class I to IV COVID-19 medical devices that are on the UPHN list may be required to submit to Health Canada information arising from broadened terms and conditions, which is otherwise not required under Part 1 of the MDR. The objective of imposing terms and conditions would be to manage the uncertainties relating to the benefits and/or risks of a product at the time of authorization or to manage emerging risks or uncertainties post-authorization. This requirement would be directly related to ensuring the health and safety of Canadians. Therefore, the costs of fulfilling the terms and conditions are not considered as an administrative burden as defined by the Red Tape Reduction Act as their primary purpose is not for ensuring compliance.

Conversely, authorization holders of Class I to IV COVID-19 medical devices which are on the UPHN list will not need to meet reporting requirements which are otherwise required under Part 1 of the MDR. This saving will apply to a total of 420 Class II to IV COVID-19 medical devices over the expected policy period, because they are not required to submit post-market annual/biennial reporting. Including Class I devices, there may initially be up to 610 COVID-19 medical devicesfootnote 8 on the UPHN list if the pandemic continues to exist. Cost savings arising from not being required to compile annual or biennial summary reports represent a decrease in annualized administrative cost of $20,316 (in 2012 dollars). This assumes that this reporting requirement would have taken over 35 hours to complete at a cost of labour of $70/hour.

With respect to the one-for-one rule, the package is an out of $20,316 (in 2012 dollars); the impacts may not be experienced equally by all affected businesses.

Regulatory cooperation and alignment

Health Canada is working with its international partners on a coordinated and well-aligned approach to responding to the COVID-19 pandemic. The Department is playing a leadership role in helping align policy approaches and regulatory agility, which involves discussing, collaborating and leveraging resources on issues related to COVID-19, including medical device authorizations.

Furthermore, Health Canada participates in the

Other comparable foreign authorities have had emergency pathways in place that enable them to provide access to COVID-19 medical devices to their populations on an expedited basis using limited information respecting a device, compared to their full authorization pathways.

United States

According to the United States Food and Drug Administration (USFDA), the United States has implemented multiple Emergency Use Authorizations (EUAs). EUAs enable the USFDA Commissioner to allow unapproved medical devices or unapproved uses for authorized devices to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases when there is a public health emergency and there are no adequate approved and available alternatives. Several devices have been issued an EUA and will continue to be authorized under these pathways with terms placed on their authorization until the EUAs are terminated or the authorization is revoked. The USFDA published a draft transition plan guidance document. The guidance proposes an approach for coming back into compliance for all devices regulated by the EUAs. The USFDA would expect manufacturers who wish to continue marketing their devices to submit the appropriate marketing application and receive authorizations. In cases where manufacturers do not submit or do not receive authorization, the draft guidance discusses the USFDA’s expectations for the disposition of those device types, which varies on whether it is single-use, life-supporting/sustaining, etc. The USFDA is currently addressing stakeholder feedback on the transition plan and will release a final version along with a companion guidance for devices that fall under COVID-19 related enforcement policies. In addition, the USFDA announced on September 27, 2022, that it will be focusing EUA applications on a subset of COVID-19 tests. This is to ensure continued access to tests while encouraging the transition of these important public health tools to traditional premarket review pathways (i.e. the de novo classification or 510(k) clearance pre-market review pathways).

European Union

The European Union adopted a proposal to extend the transitional period of its new medical device regulations by one year to May 2021 and to May 2022 for in vitro diagnostic medical devices. This measure aimed to avoid shortages of medical devices during the ongoing COVID-19 pandemic by providing member states and manufacturers with one additional year to come into compliance with the new requirements. The European Commission also adopted revised harmonized standards to expedite the production of medical face masks, gloves, containers for intravenous injections, sterilization devices, and disinfectants, and alter particular requirements for emergency and transport ventilators. The harmonized standards facilitate a faster and less expensive conformity assessment procedure.

United Kingdom

The Medicines and Healthcare products Regulatory Agency of the United Kingdom uses

Australia

The Australian Therapeutic Goods Administration (TGA) does not assess medical devices that are supplied under the; emergency exemptions these devices are exempt from TGA assessment. There were three emergency exemptions initially issued:

The emergency exemptions for ventilators and face masks ceased on January 31, 2021. The emergency exemption for accredited pathology laboratories ceased on July 31, 2020, and was replaced by an emergency exemption enabling accredited pathology labs to continue using COVID-19 tests for donor screening. This exemption ceased on June 30, 2022.

The TGA is prioritizing applications for COVID-19 tests, specifically rapid antigen and point of care tests. Conditions related to post-market validation and additional testing are also imposed on tests included on the Australian Register of Therapeutic Goods.

Alignment

The creation of interim orders most closely resembles that of the USFDA, where emergency pathways were created and used to expedite access to certain devices. The USFDA is proposing a transition approach where manufacturers are expected to submit additional data within 180 days of their EUA termination date to receive an authorization and continue marketing their device. Health Canada, in comparison, is maintaining COVID-19 medical device authorizations but is imposing certain additional requirements when a medical device is no longer on the UPHN list. These additional requirements are in line with requirements for other medical devices licensed in Canada under Part 1 of the MDR.

Rather than create emergency pathways to expedite access as Canada has done, the European Union, United Kingdom and Australia expedited access to key COVID-19 medical devices by suspending certain portions of their regulations for COVID-19 devices. Given the similarities between the regulatory systems of Canada and the United States, it made sense for Canada to follow a similar pathway to that of the United States but diverge from the approach taken by the European Union, United Kingdom and Australia, whose regulatory systems share fewer similarities with the Canadian system for medical devices.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.

Important environmental impacts have not been identified for these amendments; therefore, a detailed analysis was not warranted.

Gender-based analysis plus (GBA+)

COVID-19 was found to have direct and indirect socioeconomic and health-related impacts that varied by gender, in addition to other demographic factors. Increased age, individual health status (e.g. pre-existing medical conditions), social conditions (e.g. lower socioeconomic status, residence in long-term care facilities or crowded/remote locations, homelessness, substance use disorder, race/ethnicity, immigration or refugee status), identity (e.g. women and gender diverse individuals, racialized minorities, persons with disabilities, and First Nations, Inuit and Métis) and occupation (e.g. health care workers, emergency workers, workers who have a high degree of social contact, international business travellers) also affect vulnerability to the disease.footnote 9

The pandemic has exacerbated existing inequities in society that will likely be furthered without effective means to address COVID-19. For example, when the Government of Ontario announced a state of emergency in March 2020 that resulted in the closure of non-essential businesses, twice as many women between the ages of 25 and 54 were left unemployed as men.footnote 10 For those who remain employed, challenges related to childcare have been encountered. In most provinces, a limited supply of licensed childcare options has often led to one parent, normally the mother, having to abandon their employment.footnote 10

Visible minority women who are disproportionately represented among personal support workers were also affected. Up to 90% of such workers, who work in long-term care homes and home care work in the community, are women.footnote 11 Another example is nurses, who are predominantly women. In 2019, about 91% of regulated nurses in Canada were female.footnote 12 As such, ensuring personal protective equipment is in adequate supply and available in a timely manner serves to protect these particular women working in essential frontline health care positions.

Pregnant women or women who were recently pregnant have an increased risk of developing a severe COVID-19 illness if they are infected,footnote 13 footnote 14 footnote 15 footnote 16 compared with non-pregnant women. Severe illness means that they might need to be hospitalized, have intensive care, be placed on a ventilator to help with breathing or use extracorporeal membrane oxygenation. Pregnant women with COVID-19 also have a higher frequency of pre-eclampsia, caesarean delivery, and a higher rate of preterm birth. They might also be at increased risk of problems such as stillbirth and pregnancy loss. Care of a critically ill pregnant patient with COVID-19 requires a multidisciplinary team.footnote 17

Socioeconomic aspects show that people living in poverty or earning lower incomes are more impacted than those with a higher income.

Some examples include individuals in service industries who cannot work from home and have limited to no paid sick leave, homeless people forced from parks with no place to go,footnote 30 shelters deemed to be unsafe,footnote 17 and individuals with less access to health care,footnote 18 unstable employment,footnote 18 and less ability to stockpile food and other cleaning supplies.footnote 18

According to an article in the Canadian Medical Association Journal, those living in Indigenous communities may be at greater risk of developing severe symptoms and dying of COVID-19, given that a number of existing conditions in communities such as poor access to clean water, limited health infrastructure and overcrowding could all contribute to spreading the disease. Other socioeconomic considerations are also known to affect the health of Indigenous peoples and communities.footnote 19 COVID-19 infection rates and deaths are sensitive to variables like income, employment, housing, limited literacy or ability in Canada’s official languages,footnote 20 footnote 21 footnote 22 footnote 23 as well as fear of discrimination and lack of cultural sensitivity in health care systems, all of which are frequently present to varying degrees in Indigenous communities.footnote 24 footnote 25 footnote 26 footnote 27

There is evidence that medical devices have different risks and benefits for equity-seeking and rights-holding populations; it shows the importance of effective medical devices in Canada’s health system. For example, some recent publications have indicated that pulse oximeters may give biased readings of blood oxygen levels on darker skin. In one publication, the results found that of 7 126 patients, Black patients were 29% less likely than white patients to have their need for treatment recognized by the oxygen reader.footnote 28 Based on data reported up to May 3, 2022, the largest contributing factor for severity of diseases is the impact of age or other health conditions as well as vaccination status. In Canada, individuals 60 years and over account for just under 93% of deaths attributed to COVID-19 as of April 29, 2022. Individuals who are unvaccinated account for approximately 60% of deaths attributed to the virus as of April 10, 2022.footnote 29

The expedited pathway in these Regulations will allow for earlier authorization of medical devices that address COVID-19. As a result, the expedited pathway could benefit most individuals in Canada, but particularly those subpopulations that are most at risk of severe outcomes and those that are more likely to be exposed to infectious disease. In addition, medical devices that were authorized under the third interim order remain authorized under the Regulations. Without the Regulations, these medical devices would not remain available for import and sale, which could disproportionately negatively impact certain groups.

Implementation, compliance and enforcement, and service standards

Implementation

The Regulations will come into force the day after the day on which the third interim order ceases to have effect.

Once a COVID-19 medical device is no longer on the UPHN list, there are set timelines for the implementation of additional requirements (e.g. to apply for an MDEL, obtain a QMS certificate, pay applicable fees) for an authorization holder. The timelines take into account the level of effort and length of time required for regulated parties to comply.

To support the implementation of the Regulations, Health Canada is adapting the existing interim order guidance document, Applications for medical devices under the Interim Order for use in relation to COVID-19: Guidance document. The guidance will be published at the same time as the publication of the amendments in the Canada Gazette, Part II.

In addition, information sessions and discussions during bilateral meetings with industry groups will provide other opportunities to directly engage with stakeholders regarding COVID-19 medical devices and these Regulations. Health Canada will also keep government partners up to date through routine meetings and communications. Up-to-date information concerning COVID-19 medical devices will continue to be communicated on Canada.ca.

Compliance and enforcement

Compliance and enforcement of the Regulations will be in accordance with a risk-based approach, aligned with departmental policies, including Health Canada’s national compliance and enforcement approach for health products, Compliance and enforcement policy for health products (POL-0001).

Health Canada employs a wide range of compliance and enforcement actions and tools. The actions, tools and level of intervention used are dependent on the context and risk to health. Some actions and tools are designed to help regulated parties understand their responsibilities under the law, while other actions and tools are designed to induce compliance with the law. Following the premise that the majority of regulated parties comply with laws if they are aware of them and understand them, Health Canada actively works to promote and monitor compliance. When necessary, enforcement actions are used to address non-compliance with the law.

Manufacturers, importers and distributors will be provided with guidance to assist them in understanding and complying with the Regulations. The guidance document will include an explanation for regulated parties to meet the requirements of Part 1.1. Detailed information for stakeholders on the existing regulations is available on the Health Canada website.

Service standards

Guidance on the additional requirements of the Regulations will be outlined in the guidance document, which also specifies the service standards.

Contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Health Products and Food Branch
Health Canada
Holland Cross, Suite P2108
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: lrm.consultations-mlr@hc-sc.gc.ca