Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need): SOR/2023-277

Canada Gazette, Part II, Volume 158, Number 1

Registration
SOR/2023-277 December 19, 2023

FOOD AND DRUGS ACT

P.C. 2023-1298 December 15, 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 (Medical Devices for an Urgent Public Health Need) under section 30footnote a of the Food and Drugs Act footnote b.

Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need)

Amendments

1 The heading of Part 1.1 of the Medical Devices Regulations footnote 1 is replaced by the following:

Medical Devices for an Urgent Public Health Need

2 The heading before section 68.01 of the Regulations is replaced by the following:

Definitions and Interpretation

3 (1) The definitions COVID-19 and COVID-19 medical device in section 68.01 of the Regulations are repealed.

(2) The definitions List of Medical Devices for an Urgent Public Health Need, List of Medical Devices for Expanded Use and UPHN medical device in section 68.01 of the Regulations are replaced by the following:

List of Medical Devices for an Urgent Public Health Need
means the List of Medical Devices for an Urgent Public Health Need 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 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:
  • (a) a medical device that is set out in column 2 of Part 1 of the List of Medical Devices for an Urgent Public Health Need and that is manufactured, sold or represented for use in relation to the corresponding medical condition that is set out in column 1;
  • (b) a medical device that belongs to a category of medical devices that is set out in column 2 of Part 2 of that list and that is manufactured, sold or represented for use in relation to the corresponding medical condition that is set out in column 1. (instrument médical BUSP)

4 The Regulations are amended by adding the following after section 68.01:

68.011 For the purposes of paragraphs 68.21(1)(h), (i) and (j), and sections 68.24, 68.3, 68.31 and 68.34, a medical device for which the manufacturer holds an authorization is considered not to be a UPHN medical device if

5 Subsection 68.02(2) of the Regulations is repealed.

6 Subsection 68.03(1) of the Regulations is replaced by the following:

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

7 The Regulations are amended by adding the following after section 68.03:

Advertising — Authorized Class I Medical Device

68.031 No person shall advertise for the purpose of sale a Class I medical device for which the manufacturer holds an authorization if the device has been subjected to a change described in section 68.13 unless

8 Section 68.04 of the Regulations is repealed.

9 Section 68.1 of the Regulations is replaced by the following:

68.1 (1) The Minister may add a medical condition to column 1 of Part 1 or Part 2 of the List of Medical Devices for an Urgent Public Health Need only if the Minister has reasonable grounds to believe that

(2) The Minister may add a medical device to column 2 of 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 for the device that is related to the corresponding medical condition that is set out in column 1.

(3) The Minister may add a category of medical devices to column 2 of 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 for the devices that belong to that category that is related to the corresponding medical condition set out in column 1.

10 (1) Paragraph 68.12(b) of the Regulations is repealed.

(2) Subparagraph 68.12(c)(ii) of the Regulations is replaced by the following:

11 Paragraph 68.13(f) of the Regulations is replaced by the following:

12 Section 68.17 of the Regulations is replaced by the following:

68.17 The Minister shall refuse to amend an authorization for a medical device if the effect of the proposed amendment would be that the device would not be authorized in relation to at least one of the following medical conditions:

13 Section 68.21 of the Regulations is amended by adding the following after subsection (1):

(1.1) If a medical device ceases to be a UPHN medical device after an application for an authorization is submitted under section 68.11 but before the Minister issues the authorization under section 68.12, the reference to “the device ceases to be a UPHN medical device” in subparagraph (1)(h)(i), (i)(i) or (j)(i), as the case may be, shall be read as “the Minister issued the authorization”.

(1.2) Subsection (1.1) ceases to apply in respect of the medical device if the device is authorized in relation to a medical condition that qualifies it as a UPHN medical device.

14 Paragraph 68.22(c) of the English version of the Regulations is replaced by the following:

15 The Regulations are amended by adding the following after section 68.24:

Notification — Suspension or Revocation

68.241 (1) This section applies to the holder of an authorization for a medical device that was issued in respect of an application submitted on the basis of subsection 68.11(4).

(2) If the holder of an authorization for a medical device receives or becomes aware of information to the effect that the authorization or licence for sale of the device that was issued by the regulatory agency is suspended or revoked, the holder shall notify the Minister within 72 hours after they receive or become aware of the information, whichever occurs first.

(3) However, the holder is not required to notify the Minister if they or the holder referred to in paragraph 68.3(1)(b) submits that information under section 68.3.

16 Section 68.26 of the Regulations is replaced by the following:

68.26 If the manufacturer of a medical device holds an authorization for the device, the importer of a shipment of the device shall ensure that the shipment is accompanied by a copy of the authorization.

17 Section 68.3 of the Regulations is replaced by the following:

68.3 (1) This section applies to the following holders of therapeutic product authorizations:

(2) The holder of a therapeutic product authorization 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 a device referred to in paragraph (1)(a), regarding

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

68.301 (1) Despite subsection 68.3(2), if the holder of a therapeutic product authorization issued in respect of a medical device is the manufacturer, they may permit the importer of the device to submit the information required under that subsection on the manufacturer’s behalf if the information that the manufacturer and the importer must submit is identical.

(2) The manufacturer shall advise the Minister in writing if the manufacturer has permitted the importer to submit the information on the manufacturer’s behalf.

18 The portion of subsection 68.31(1) of the Regulations before paragraph (a) is replaced by the following:

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

19 Subsection 68.34(1) of the Regulations is replaced by the following:

68.34 (1) If a new or modified quality management system certificate is issued in respect of a medical device for which the manufacturer 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.

20 Section 68.35 of the Regulations is replaced by the following:

68.35 Subject to sections 21, 23 and 44, if an authorization for a medical device is cancelled under paragraph 68.21(1)(h), (i) or (j), a person other than the manufacturer 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.

21 The Regulations are amended by adding the following before section 68.36:

68.351 The Minister may add a medical condition to column 1 of the List of Medical Devices for Expanded Use only if the Minister has reasonable grounds to believe that

22 (1) The portion of subsection 68.36(1) of the Regulations before paragraph (b) is replaced by the following:

68.36 (1) The Minister may add a licensed medical device, or a Class II, III or IV medical device for which the manufacturer holds an authorization, to column 2 of the List of Medical Devices for Expanded Use and an expanded use to column 3 only if the following conditions are met:

(2) Paragraphs 68.36(2)(a) and (b) of the Regulations are replaced by the following:

(3) Subsection 68.36(3) of the Regulations is replaced by the following:

(3) In the case of a Class II, III or IV medical device for which the manufacturer 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

23 The portion of section 68.37 of the Regulations before paragraph (a) is replaced by the following:

68.37 The Minister shall publish on the Government of Canada website supplementary information pertaining to the expanded use, set out in column 3 of the List of Medical Devices for Expanded Use, of a licensed medical device — or a Class II, III or IV medical device for which the manufacturer holds an authorization —, set out in column 2 of that list, including

24 Subsections 68.38(1) and (2) of the Regulations are replaced by the following:

68.38 (1) The Minister may request from the holder of a medical device licence, in respect of the medical device that is set out in column 2 of the List of Medical Devices for Expanded Use for which the licence was issued, any information in relation to the expanded use that is set out in column 3 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 medical device set out in column 2 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 3 of that list that the holder possesses or to which they have reasonable access.

25 The Regulations are amended by replacing “COVID-19 medical device” with “medical device” in the following provisions:

26 The Regulations are amended by replacing “manufacturer of the device” with “manufacturer” in the following provisions:

Transitional Provisions

27 (1) In this section, authorization has the same meaning as in section 68.01 of the Medical Devices Regulations.

(2) In respect of an authorization for a medical device that is issued before the day on which these Regulations come into force, paragraph 68.17(a) of the Medical Devices Regulations is to be read as follows:

(3) Section 68.17 of the Medical Devices Regulations, as it read immediately before the day on which these Regulations come into force, applies in respect of an application to amend an authorization that was submitted under section 68.14 of the Medical Devices Regulations before the day on which these Regulations come into force and in respect of which no decision has been made before that day.

Coming into Force

28 These Regulations come into force on the day on which they are published in the Canada Gazette, Part II.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues: The nature and duration of public health emergencies can be unpredictable and can affect medical device supply chains. Existing authorities under the Food and Drugs Act, such as the authority to make interim orders, do not provide stability or predictability to stakeholders and Health Canada given their limited duration of up to one year. As well, the existing licensing pathway in Part 1 of the Medical Devices Regulations (MDR) is not designed to accelerate access to medical devices for which there is an urgent public health need in Canada. Without a permanent expedited authorization pathway that could be tailored to different public health emergencies beyond COVID-19, the Government of Canada may experience challenges with addressing supply chain issues during future public health emergencies.

Description: The Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) (the Regulations) will broaden the COVID-19 medical devices framework under Part 1.1 of the MDR to apply to other medical conditions that present, or are the result of, a significant risk to public health in Canada, and require immediate action to deal with the risk.

The Regulations will also address a policy gap by allowing the Minister more flexibility to manage applications in queue. In addition, the Regulations will clarify certain post-market reporting requirements – namely, make explicit the obligation to inform the Minister of a suspension or revocation of an authorization by a foreign regulatory agency.

Rationale: The Regulations will allow accelerated access to medical devices for which there is an urgent public health need in Canada without relying on temporary regulatory measures. Amending the MDR will provide predictability and stability to Health Canada as a regulator as well as to manufacturers, importers and distributors of medical devices that may be needed to address future public health emergencies. The Regulations will generally provide the same requirements and reductions in administrative burden for businesses and the Government of Canada in respect of medical devices required to address future public health emergencies as are currently available relating to COVID-19 medical devices. While new applicants seeking authorizations under Part 1.1 will benefit from some savings, incremental costs may result if their new medical devices are authorized with terms and conditions.

Issues

Evolving disease trends and global health incidents may result in future public health emergencies and create challenges in global supply chains for medical devices that require timely response from the Government of Canada.

Specifically, the Government of Canada’s ability to respond to future public health emergencies requires the following issues to be addressed:

  1. The unpredictable nature and duration of public health emergencies can create challenges that impact medical device supply chains.
  2. While authorities under subsection 30.1(1) of the Food and Drugs Act allow the Minister of Health to make interim orders if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment, this instrument does not provide stability or predictability to stakeholders and Health Canada given its limited duration of up to one year.
  3. The licensing pathway under Part 1 of the MDR is not designed to approve medical devices in an expedited manner to address public health emergencies. The previously published Part 1.1 of the MDR could only be used to expedite approvals for COVID-19 devices. Additionally, the Special Access Program under Part 2 of the MDR is only intended for use to treat patients on an individual basis.

Canada may continue to encounter challenges in the event of future public health emergencies if a permanent regulatory framework is not introduced to facilitate access to critical medical devices.

Background

On February 22, 2023, 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 COVID-19 Medical Devices Regulations) came into force and created a permanent regulatory framework under Part 1.1 of the MDR for COVID-19 medical devices.

Under Part 1.1, the Minister can:

Applicants and authorization holders under Part 1.1 are provided certain flexibilities when their medical device is on the UPHN list (e.g. exemptions from fee requirements, medical device establishment licences (MDELs), quality management system certificates). Once a COVID-19 medical device is no longer on the UPHN list, authorization holders of that device need to comply with certain additional requirements, aligned with Part 1 requirements, to continue to import or sell their medical device.

Objective

The objective of the Regulations is to broaden the previously published COVID-19 medical devices framework under Part 1.1 of the MDR to other public health emergencies. This will optimize the available mechanisms and flexibilities to facilitate timely access to safe and effective medical devices as urgent public health needs arise in Canada in the future.

Description

There are two elements to the Regulations:

  1. Amendments to provisions in Part 1.1 of the MDR to broaden the previously published COVID-19 framework to apply to other public health emergencies; and
  2. Amendments to address a policy gap and clarify certain post-market requirements from the original Part 1.1 framework.

In line with the COVID-19 medical devices framework, the broadened pathway is optional. The general licensing framework under Part 1 of the MDR will remain available for manufacturers to consider.

Amendments to broaden Part 1.1

List of Medical Devices for an Urgent Public Health Need

Previously, under Part 1.1 of the MDR, the Minister could have added a medical device to Part 1 or a category of devices to Part 2 of the UPHN list if the Minister had reasonable grounds to believe that there was an urgent public health need related to COVID-19 for the devices.

The Regulations will restructure the UPHN list and introduce a new authority for the Minister to add medical conditions to the UPHN list if the Minister has reasonable grounds to believe that:

Authorities will be modified in Part 1.1 to enable the Minister to add a medical device or a category of devices to the UPHN list if the Minister has reasonable grounds to believe that there is an urgent public health need in relation to a listed corresponding medical condition.

List of Medical Devices for Expanded Use

Similar authorities will be introduced to modify the Expanded Use list to allow the Minister to add medical conditions to the Expanded Use list. Consequential amendments to the expanded use provisions will allow the Minister to issue expanded use indications for Class II to IV authorizations under Part 1.1 or for devices licensed under Part 1 if there are reasonable grounds to believe there is an urgent public health need related to a listed corresponding medical condition.

Amendment requirements for Class I medical devices

The Regulations will require Class I medical device authorization holders under Part 1.1 to submit an amendment application if they intend to change the medical conditions, purposes, or uses of the device. Previously, as only COVID-19 medical devices were authorized under Part 1.1, Class I authorization holders were only required to submit an amendment application under Part 1.1 if they intended to change the class of the device, the name of the manufacturer or device, or the identifier of the device. This new requirement aligns with current prohibition policy for Class II to IV medical devices and will close gaps in oversight in the broadened framework.

Changes in refusal authorities regarding amendments to authorizations

Refusal authorities under Part 1.1 will be amended to provide the Minister with the authority to refuse to amend an authorization if the manufacturer of a Class I, II, III or IV device intends to change the purpose of the device to make it unrelated to:

These changes to the refusal authorities will allow the authorization holder to amend their authorization such that the device can be authorized for a medical condition other than the one for which the device was initially authorized, if all the applicable amendment requirements have been met.

Prohibition on advertising

As noted above, the Regulations will require authorization holders of Class I devices to amend their authorization if their device is the subject of a change in medical condition, purpose or use. As a result, a prohibition has been added to restrict the advertising of Class I medical devices under Part 1.1 if the device is subject to a change that requires an amendment, and the authorization has not been amended. This prohibition mirrors the existing advertising prohibition for Class II, III and IV devices in the MDR.

Amendments to address a policy gap and clarify existing requirements

Applications in queue

Previously, under Part 1.1, medical devices were required to be on the UPHN list when a manufacturer submitted their application and on the UPHN list when the Minister made the decision to issue an authorization.

The Regulations will remove the requirement for the device to be on the UPHN list when the Minister issues the authorization. This will allow Health Canada to continue to review an application that is in progress or in queue and the Minister to issue an authorization even if the UPHN list changes before a decision is made. This amendment will give manufacturers the assurance that their application will be assessed as long as they meet all issuance criteria, and their medical device was on the UPHN list when they submitted their application.

Obligation to inform the Minister

Under Part 1.1, the Minister may cancel an authorization that was issued in respect of an application based on an authorization issued by a regulatory agency on the Regulatory Agencies list, if the Minister becomes aware that the authorization or licence for sale of the device that had been issued by the foreign regulatory agency is suspended or revoked. However, previously in Part 1.1, the requirement to notify the Minister of this information was in respect of a serious risk of injury to human health and it only applied to Class II, III, and IV medical devices that are not on the UPHN list.

To ensure safety of the device, the Regulations will require all holders of authorizations issued based on an authorization approved by a regulatory agency on the Regulatory Agencies list to notify the Minister within 72 hours after the holder receives notice or becomes aware that their authorization or licence issued by a foreign regulatory agency has been suspended or revoked.

Post-Market reporting

The Regulations will clarify the post-market reporting obligations and make it more explicit that both the authorization holder and the importer of a Class II, III, or IV medical device that is removed from the UPHN list must report to the Minister information with respect to serious risk of injury to human health. This revision aligns with the post-market reporting requirement in Part 1 of the MDR.

Additional changes

The Regulations will make several minor amendments to better comply with standard approaches for regulatory drafting and to maintain consistency between the English and French texts. The additional changes also include the introduction of an interpretation provision to clarify what device is not considered a UPHN medical device.

In addition, references to COVID-19 will be removed from the relevant sections of Part 1.1 of the MDR.

Regulatory development

Consultation

May 2022 (Notice of Intent)

The Notice of Intent for the COVID-19 Medical Devices Regulations that was posted for public consultation on May 2, 2022, for 21 days, informed the development of the COVID-19 Medical Devices Regulations. Health Canada received six stakeholder responses, of which half related to the scope of the COVID-19 Medical Devices Regulations proposal and the other half related to input beyond the scope of those regulations.

Stakeholders supported the proposed changes and advocated for broadening the intended COVID-19 pathway to other ’declared pandemic or health emergency’ situations rather than targeting only COVID-19.

March-April 2023 (Notice of Intent)

Health Canada posted a Notice of Intent on the Department’s website to solicit stakeholder feedback for this proposal on March 23, 2023. The consultation was open for 21 days and closed on April 13, 2023.

Comments were received from five industry stakeholders and associations. Stakeholders generally supported the proposed changes.

Regarding the then-proposed amendments to Part 1.1 of the MDR, stakeholders primarily sought clarifications (e.g. implementation details related to timelines, criteria for medical conditions and number of medical conditions per device, and process related to amending Class I device authorizations). Health Canada will address the stakeholder feedback in their updated guidance document.

While Health Canada did not propose changes to the existing Medical Device Single Audit Program (MDSAP) requirements in the Notice of Intent, some stakeholders also provided feedback on those requirements under Part 1.1 and its associated fees. To maintain and ensure quality standards for medical devices under Part 1.1, amendments relating to MDSAP requirements have not been added to the Regulations as a result of the stakeholder feedback. Under Part 1.1, manufacturers of Class II to IV devices must continue to meet these requirements after their device is removed from the UPHN list to maintain their authorization.

In April 2023, Health Canada also held an engagement session on the proposed amendments with industry associations (including members from Medtech Canada, the Dental Industry Association of Canada and the Canadian Council of Innovators). Health Canada also encouraged provincial and territorial partners to provide feedback, through the Public Health Agency of Canada’s Logistics Advisory Committee and the Public Health Emergency Management Task Group. No concerns were raised.

August-September 2023 (Notice to World Trade Organization Members)

In August 2023, the Government of Canada published a notice to inform World Trade Organization Members about the proposed amendments, including the fees. The comment period was 21 days and referenced the above-mentioned Notice of Intent that was published on March 23, 2023. There were no concerns raised.

Exemption from prepublication

Health Canada sought an exemption from prepublication in the Canada Gazette, Part I, for the regulatory amendments. These amendments are targeted changes to broaden an authorization pathway that is already in place and are not intended to create a new additional pathway in the MDR. Health Canada has had the opportunity to implement and to identify gaps and areas for improvement in the previously published Part 1.1 pathway as well as consult on these amendments in spring/summer 2023. Stakeholders had also previously advocated for broadening Part 1.1 to address other health emergencies beyond COVID-19. The amendments will contribute to ensuring predictability for stakeholders without relying on temporary regulatory measures like an interim order. They will also enable the Government of Canada to address new urgent public health needs related to future public health emergencies beyond COVID-19, while maintaining safety, effectiveness and quality.

These regulatory amendments will also be largely aligned with the previously published Part 1.1 of the MDR. New policy changes will align with elements of Part 1 of the MDR to ensure appropriate long-term oversight of the authorized medical devices. Through the consultation process, stakeholders did not identify significant concerns with these Part 1.1 amendments, which are expected to have a low impact on industry.

Modern treaty obligations and Indigenous engagement and consultation

As required by the Cabinet Directive on the Federal Approach to Modern Treaty Implementation, a detailed 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 using the MDR

The licensing pathway under Part 1 of the MDR is not designed to approve medical devices in an expedited manner to address public health emergencies. The previously published Part 1.1 of the MDR would only apply to COVID-19 medical devices. The Special Access Program under Part 2 of the MDR is only intended for use to treat patients on an individual basis.

For this reason, the status quo option was not deemed adequate to address the objective given that accelerated access to medical devices for use in an urgent public health need may be required to address future public health emergencies.

Option 2: Interim order

In the event of a future public health emergency, the Minister of Health has the authority under the Food and Drugs Act to make an interim order if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment. 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 medical devices for which there is an urgent public health need.

For this reason, the interim order option was not deemed adequate to address the objective, 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 if the public health emergency extends past one year.

Option 3: Amendments to the MDR

Under this selected option, the MDR is being amended to broaden the previously published regulatory framework under Part 1.1 to apply to future public health emergencies. This will enable the Government of Canada to address any new urgent public health needs related to a listed medical condition, 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 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. to hold an MDEL, to obtain an MDSAP-issued quality management system certificate) should they choose to retain their authorization.

Regulatory analysis

Benefits and costs

The cost-benefit analysis aims to inform major stakeholders (including businesses, consumers and Health Canada) of the impacts of the Regulations. To analyze the benefits and costs associated with the proposed amendments, Health Canada examined internal data gathered through the COVID-19 pandemic response and applied costs from the cost-benefit analysis conducted for 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). From the analysis, it was determined that the cost impact to stakeholders will be low.

There is significant uncertainty in assuming at what future point medical devices may be added to the UPHN list to address a public health emergency. A significant public health emergency that would require medical devices to be added to the UPHN list is likely a rare event. The COVID-19 pandemic was considered a once in 100-year event,footnote 2 comparable only to the 1918-20 Spanish Flu. Since the Spanish Flu outbreak, Canada has been able to manage the need for medical devices to address public health outbreaks with existing resources in the health care system supplemented with the National Emergency Strategic Stockpile. However, expanding international travel, climate change, the resurgence of previously eradicated diseases and the state of science are all factors that may impact the future need for certain medical devices in Canada. The Regulations will provide the Minister with the authority to amend the UPHN list in order to respond to future emergent and urgent public health needs on a varying scale (i.e. to add a medical condition, a medical device or a category of devices). Health Canada would proactively engage and consult relevant health authorities in amending the UPHN list.

Baseline scenario

Entry to the market via the regulatory framework under Part 1.1 of the MDR was only available for the authorization of COVID-19 medical devices listed on the UPHN list. Thus, for the baseline scenario, businesses seeking authorization for new medical devices for other medical conditions that present, or are the result of, a significant risk to public health in Canada, and require immediate action to deal with the risk would have to meet the requirements under Part 1 of the MDR in order to import or sell their device in Canada.

Policy scenario

The Regulations will broaden the previously published COVID-19 medical devices framework under Part 1.1 of the MDR to apply to other public health emergencies and will maintain most of the previous Part 1.1 requirements and exemptions. Ongoing market participation under the Regulations will continue to 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 medical device manufacturers who wish to have their medical device stay on the Canadian market upon the medical device’s removal from the UPHN list will have to transition to Part 1 of the MDR and be subject to MDEL requirements. For Class II to IV medical devices that are no longer on the UPHN list, the Regulations will provide businesses with sufficient time to comply with the additional requirements described in Part 1.1 of the MDR if they choose to keep their authorization. With regard to medical devices for which the authorization holders choose to leave the Canadian market, importers and distributors will continue to have a six-month sell off period to deplete existing stock once the authorization is cancelled.

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

Costs
I. Industry

New medical device authorization holders under Part 1.1 of the MDR may incur incremental costs if subject to terms and conditions while their device is listed on the UPHN list. For the purposes of the cost-benefit analysis, the cost to industry to meet the terms and conditions for Class I to IV medical devices is acknowledged qualitatively, given that Health Canada has no certainty of the number or breadth of terms and conditions to be issued under the Regulations, nor their timing. In line with the previously published COVID-19 medical devices framework, the broadened pathway is optional. Once removed from the UPHN list, manufacturers can choose between Part 1 or Part 1.1 to sell their medical devices, and hence any ongoing costs from terms and conditions can be mitigated.

II. Government

Upon the determination that devices are urgently needed, Health Canada is anticipated to incur expenses for the review time of new applications that would not have been expected to be submitted under Part 1 of the MDR. While the scope of magnitude cannot be assumed due to the uncertain nature of a future event, management of applications for medical device authorizations under Part 1.1 of the MDR will impose resource costs on Health Canada to process, coordinate, screen and review those applications. The costs incurred for the review of an application under Part 1.1 will be comparable to Part 1 of the MDR; however, these costs will vary according to the mix of possible medical device classes included.

It is also anticipated that Health Canada will incur expenses to conduct compliance and enforcement actions, including resources dedicated to incident reports, recalls, compliance verifications and inspections for new medical devices that are authorized under Part 1.1 of the MDR. Further, for compliance and enforcement actions such as a stop sale, suspension, licence cancellation, or seizure, Health Canada could incur additional costs depending on the circumstances of a significant future public health emergency.

Benefits

The Regulations will allow for accelerated access to safe and effective medical devices for urgent public health needs as they arise in the future. Without the Regulations, Canadians might not have prompt access to vital medical devices to address their needs. Issuing an interim order remains an option under certain circumstances. However, the limitations (outlined above) make it such that interim orders do not provide the benefit of a stable and predictable regulatory pathway over the longer term. The broadening of the previously published COVID-19 medical devices framework under Part 1.1 of the MDR will provide flexibility to facilitate timely access to needed medical devices to respond to future public health emergencies and will result in cost savings to industry stakeholders, convenience, and a wider array of medical devices available to consumers.

I. Industry

The Regulations will provide manufacturers and importers of medical devices with a permanent expedited authorization pathway to enter the Canadian market in the case of a future public health emergency. New medical devices authorized under Part 1.1 may benefit from the reduced burden of market entry and potential administrative cost savings related to reporting requirements which are otherwise required under Part 1 of the MDR. For medical devices that are no longer on the UPHN list, authorization holders will need to comply with certain additional requirements that are also required of medical device licence holders in Canada, to continue to import or sell their medical device. By broadening the previously published COVID-19 medical devices framework under Part 1.1 of the MDR to other public health emergencies and by continuing to offer a transition period for medical devices that are no longer on the UPHN list to meet either requirements under Part 1 (for Class I devices) or Part 1.1 (for Class II to IV devices), businesses will be provided flexibility in accessing the Canadian market, if they choose to keep their authorization.

II. Government

During the COVID-19 pandemic, the Government of Canada made three consecutive interim orders respecting the importation and sale of medical devices for use in relation to COVID-19. Each interim order required the allocation of significant resources to create and implement them that could have been used to address other issues stemming from the pandemic. The Regulations will provide a permanent expedited authorization pathway to access medical devices to support the Government of Canada’s ability to promptly respond to future public health emergencies without having to rely on temporary regulatory measures.

III. Health Care System and Canadians

Public health emergencies can place a significant burden on the health care system, taxing it not only in terms of human resources, but also in terms of access to a sufficient supply of high-quality, safe, and effective medical devices for health care professionals and the general public’s protection. The Regulations will benefit Canadians and help the health care system respond to future emergencies promptly by facilitating access to safe and effective medical devices for the diagnosis, treatment, mitigation, or prevention of medical conditions that present, or are the result of, a significant risk to public health in Canada.

Small business lens

Analysis under the small business lens concluded that the Regulations may impact small businesses. Based on the authorization of medical devices for the COVID-19 pandemic, a large proportion (70%) of Canadian businesses that responded to the 2020-21 cost-benefit analysis survey indicated that they met the definition of a small business. It is anticipated that future implicated small businesses may benefit from the Regulations due to the reduced burden of market entry relative to Part 1 of the MDR. Future Class II to IV authorization holders will similarly have the choice to maintain their authorizations under Part 1.1, if certain requirements are met, should their medical device be removed from the UPHN list.

Small businesses applying under Part 1.1 will also continue to face reduced administrative burden from provisions exempting post-market reporting for authorized medical devices on the UPHN list. For authorization holders of medical devices that are removed from the UPHN list, the Regulations will continue to allow 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 quality management system certification process. Manufacturers who choose not to comply with these additional requirements may have their authorizations cancelled, while importers and distributors will continue to have a six-month sell off period to deplete any existing stock.

One-for-one rule

The one-for-one rule applies since there is a potential incremental decrease in administrative burden on business, and the proposal is considered burden out under the rule. No regulatory titles are repealed or introduced.

Under Part 1.1, authorization holders of Class I to IV medical devices on the UPHN list will not need to meet reporting requirements, which are otherwise required under Part 1 of the MDR. Based on the authorization of medical devices for the COVID-19 pandemic, the estimated cost savings arising from not being required to meet these reporting requirements represents a decrease in annualized administrative cost of $1,901 or $22 per business (in 2012 dollars and measured according to the required method of the Red Tape Reduction Regulations). This estimate applies a probabilistic factor to potential cost savings in the event of a future public health emergency and assumes that the avoided reporting requirements would have taken 35 hours to complete per business at a cost of labour of $70/hour (in 2022 dollars).

Authorization holders of Class I to IV 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 medical device 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 administrative burden as defined by the Red Tape Reduction Act as their primary purpose is not for ensuring compliance.

Regulatory cooperation and alignment

The Regulations will broaden the previously published COVID-19 medical devices framework to apply to other public health emergencies. This will provide greater harmonization with other international jurisdictions that have emergency authorization pathways that apply to a broader range of medical devices than COVID-19 medical devices.

United States

The United States Food and Drug Administration (USFDA) has provisions for Emergency Use Authorizations (EUAs) that support emergency preparedness and foster the availability of medical products for use in emergencies. If the Health and Human Services Secretary declares that there is a public health emergency, or a significant potential for a public health emergency, the USFDA may authorize unapproved medical devices or unapproved uses of medical devices to be used to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met.

The USFDA has the authority to set out certain mandatory conditions on an EUA, such as information that must be provided to health care professionals, monitoring and reporting of adverse events, and record keeping. Other conditions may also be imposed at the discretion of the USFDA, such as limitations on distribution, administration, and advertising. When an EUA declaration is terminated, any EUAs issued based on that declaration are also terminated.

During the COVID-19 pandemic, a number of devices were 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. Manufacturers of devices authorized by an EUA will have a 180-day transition period during which they may choose to seek a marketing authorization for their device, or to withdraw their device from the market. The USFDA has also employed these provisions and issued EUAs for other public health emergencies in the past.

European Union

The European Commission (EC) has provisions in place to allow European Union (EU) member states to grant special temporary authorizations for medical devices that have not yet had conformity assessment procedures if it is “in the interest of public health or patient safety or health”.footnote 3 This special authorization generally applies only for the territory of the authorizing member state, which must consider how critical the device is and the availability of appropriate substitutes. Member states are required to inform the EC and other member states of any national derogation granted for a medical device.

In exceptional cases relating to public health or patient safety or health, the EC also has the authority to extend for a limited period of time the validity of such special authorizations granted by a member state to the entire EU and set the conditions under which the device may be placed on the market or put into service. Unless determined otherwise, EU-wide derogations remain in force no more than six months.

United Kingdom

Similar to the EU, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (UK MHRA) has provisionsfootnote 4 that allow temporary authorizations of medical devices that do not comply with the United Kingdom’s standard conformity assessment procedure, or do not meet the essential requirements of relevant EU medical device directives, when there is a justified request and in the interest of the protection of health. These devices can be placed on the market for a specified period and may be subject to certain conditions.

Australia

The Australian Therapeutic Goods Administration (TGA) implemented a number of emergency measures in response to COVID-19, including measures to accelerate the registration of medical devices or to exempt them from registration in certain circumstances. The TGA does not assess medical devices that are supplied under the emergency exemptions. Medical devices approved via this pathway were subject to robust post-market validation as well as an expedited recall pathway. However, the emergency regulatory measures have since been largely repealed and there is no indication in publicly available materials of any plans to implement a permanent emergency pathway.

Alignment

The broadened pathway under Part 1.1 of the MDR most closely resembles the approach of the USFDA, where emergency pathways were created and used to expedite access to certain devices. The USFDA has outlined 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 Part 1.1 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 EU, United Kingdom and Australia expedited access to key COVID-19 medical devices by suspending certain portions of their regulations for COVID-19 devices only. To provide predictability and stability to manufacturers, importers and distributors of medical devices that may be needed to address future public health emergencies, Canada has opted to align more closely with the USFDA.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that there will be no expected important environmental effects, either positive or negative; therefore, a detailed strategic environmental assessment is not required.

Gender-based analysis plus (GBA+)

Medical devices are used for diagnosing, treating, mitigating or preventing a disease, disorder, or abnormal physical state, or any of their symptoms. While the regulatory amendments will directly impact the regulated parties of medical devices for an urgent public health need (e.g. those that sell or import these devices), all individuals that use the medical devices authorized under Part 1.1 have the potential to benefit indirectly. Some subpopulations may receive a greater benefit as they are expected to be disproportionately and negatively affected by future public health emergencies.

Factors such as gender, increased age, social conditions (e.g. lower socioeconomic status, residence in long-term care facilities or crowded/remote locations, homelessness, substance use disorder),footnote 5,footnote 6 identity (e.g. women and gender diverse individuals,footnote 7,footnote 8 persons with disabilities, and First Nations, Inuit and Métis)footnote 9,footnote 10 and occupation (e.g. health care workers, emergency workers, cleaners, retail workers, personal and customer service) can affect vulnerability to infectious disease.footnote 10

Based on data from the recent COVID-19 pandemic, women and gender diverse individuals and racial and ethnic minorities face increased risk of exposure to infectious disease and are more likely to have jobs that require them to be in contact with large numbers of people.footnote 10 For example, visible minority women are disproportionately represented amongst personal support workers and up to 90% of personal support workers are women.footnote 11 In addition, nurses are predominantly women. In 2021, about 91% of regulated nurses in Canada were female.footnote 12 As such, ensuring that there is an adequate supply of personal protective equipment that is available in a timely manner serves to protect these women working in essential frontline health care positions.

Other groups may be more vulnerable due to likelihood of exposure to infectious disease due to geographic or economic barriers, or difficulty carrying out preventive activities. As an example, according to a Public Health Agency of Canada companion report, Indigenous communities may face difficulties in following the public health guidelines of physical distancing and limiting close contact to one’s household and immediate family. Some Indigenous Peoples may lack the space needed to physically distance or isolate (e.g. urban areas, overcrowded homes). In some First Nations and Inuit homes, overcrowding leads to shift sleeping or inaccessibility of bathroom facilities that increase one’s risk of infection.footnote 13

Certain populations are also at risk of more severe outcomes following infectious disease transmission. Findings from recent COVID-19 data indicated pregnant women or women who were recently pregnant have an increased risk of developing a severe illness if they are infected compared with non-pregnant women.footnote 14,footnote 15 Severe illness in this context means that they might need to be hospitalized, require 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 preterm birth.footnote 16 An expedited approval pathway for medical devices for which there is an urgent public health need may result in earlier access to critical medical devices and provide more benefit to these populations.

There is also evidence that medical devices have different risks and benefits to equity-seeking and rights-holding populations; it shows the importance of leveraging post-market medical devices data and having 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 of darker skin populations. In one publication, the results found that reliance on pulse oximetry in guiding triage and therapy decisions throughout the COVID-19 pandemic may have placed patients of darker skin at increased risk of delayed treatment.footnote 17 By maintaining the applicable post-market requirements for devices authorized under Part 1.1, this allows Health Canada to be made aware of changes related to the benefits and risks associated with the device. It is also expected that a less burdensome authorization process may encourage the development of devices more specifically targeted at affected populations.

Implementation, compliance and enforcement, and service standards

Implementation

The Regulations will come into force the day on which the Regulations are published in the Canada Gazette, Part II.

Active authorizations issued under the previously published COVID-19 medical devices framework will be maintained under the amended Regulations. Once a medical device is no longer on the UPHN list, there are existing set timelines for the implementation of additional requirements (e.g. to apply for an MDEL, obtain a quality management system 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.

Health Canada will publish an updated guidance document following the publication of the amendments in the Canada Gazette, Part II to support the implementation of the Regulations.

In addition, information sessions and discussions during bilateral meetings with industry groups will provide other opportunities to directly engage with stakeholders regarding these Regulations and the related guidance. Health Canada will also keep government partners up to date through routine meetings and communications.

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 Regulations will be 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
Policy, Planning & International Affairs Directorate
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