Order Amending the Fees in Respect of Drugs and Medical Devices Order (Medical Devices for an Urgent Public Health Need): SOR/2023-278
Canada Gazette, Part II, Volume 158, Number 1
Registration
SOR/2023-278 December 19, 2023
FOOD AND DRUGS ACT
Whereas, under section 30.62footnote a of the Food and Drugs Act footnote b, the Minister of Health has consulted with any persons that the Minister considers to be interested in the matter;
Therefore, the Minister of Health makes the annexed Order Amending the Fees in Respect of Drugs and Medical Devices Order (Medical Devices for an Urgent Public Health Need), under subsections 30.61(1)footnote a and 30.63(1)footnote a of the Food and Drugs Act footnote b.
Ottawa, December 18, 2023
Mark Holland
Minister of Health
Order Amending the Fees in Respect of Drugs and Medical Devices Order (Medical Devices for an Urgent Public Health Need)
Amendments
1 The definition performance standard in subsection 1(1) of the Fees in Respect of Drugs and Medical Devices Order footnote 1 is replaced by the following:
- performance standard
- means the document entitled Performance Standards for the Fees in Respect of Drugs and Medical Devices Order, published by the Government of Canada on its website, dated September 11, 2023. (norme de rendement)
2 The portion of the definition authorization in section 59 of the Order before paragraph (a) is replaced by the following:
- authorization
- means an authorization for a medical device issued under section 68.12 of the Medical Devices Regulations, if the device
3 Section 60 of the Order is amended by adding the following after subsection (1):
Exception
(1.1) Subsection (1) does not apply in respect of an application to amend an authorization for a medical device if the purpose of the application is to authorize the device in relation to a medical condition that qualified it as a UPHN medical device when the application was submitted.
4 The portion of the definition authorization in section 76 of the Order before paragraph (a) is replaced by the following:
- authorization
- means an authorization for a medical device issued under section 68.12 of the Medical Devices Regulations, if the device
| Item | Column 2 Description |
|---|---|
| 2 | Applications for amendment of Class II medical device licence or applications to amend authorization filed under section 68.14 of the Medical Devices Regulations for a Class II medical device that is not a UPHN medical device, other than applications referred to in item 10 |
6 The Order is amended by replacing “COVID-19 medical device” with “medical device” in the following provisions:
- (a) paragraph 2(1)(e);
- (b) subsection 77(1);
- (c) the portion of items 5 and 6 of Schedule 8 in column 2; and
- (d) the portion of items 8 to 10 of Schedule 8 in column 2.
Coming into Force
7 This Order comes into force on the day on which the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) come into force, but if it is registered after that day, this Order comes into force on the day on which it is registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Order.)
Issues
The Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) will broaden the COVID-19 medical devices framework under Part 1.1 of the Medical Devices Regulations (MDR) to include other public health emergencies.
Without amending the Fees in Respect of Drugs and Medical Devices Order (Fees Order), Health Canada will not be able to charge applicable fees when a medical device authorized under the broadened framework is no longer on the List of Medical Devices for an Urgent Public Health Need (UPHN list) under the MDR.
Background
COVID-19 Medical Devices Regulations
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) came into force and created a permanent regulatory framework under Part 1.1 of the MDR for COVID-19 medical devices.
To apply certain fees (i.e. amendment fees and right to sell fees) to COVID-19 medical devices no longer required to meet an urgent public health need under Part 1.1, the Minister of Health made the Order Amending the Fees in Respect of Drugs and Medical Devices Order (COVID-19 Medical Devices), which came into force on February 22, 2023.
Amendments to broaden Part 1.1 of the MDR
The MDR will be amended to broaden the previously published COVID-19 medical devices framework under Part 1.1 to other public health emergencies, and the UPHN list will be restructured.
Under the amended MDR, the Minister will be able to add medical conditions to the UPHN list if the Minister has reasonable grounds to believe that:
- the medical condition presents, or is the result of, a significant risk to public health in Canada; and
- immediate action is required to deal with the risk.
Authorities will be modified in Part 1.1 to enable the Minister to add a medical device or a category of device 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.
Manufacturers of these medical devices will be able to access the Part 1.1 regulatory framework, and if they are issued an authorization, they will be subject to certain flexibilities, including fee exemptions, until their devices cease to be on the UPHN list.
Objective
The objective of the amendments to the Fees Order is to ensure that once a Class II to IV medical device is no longer on the UPHN list under the broadened Part 1.1 regulatory framework, the authorization holder for the device will be charged:
- fees for the examination of applications to amend an authorization; and
- the annual right to sell fee.
Description
The Fees Order will retain the previously published Part 1.1 fee requirements and exemptions apart from the consequential amendments outlined below.
Overview of fee requirements
Authorization holders will continue to not be subject to fees while their medical device is on the UPHN list. If a medical device is authorized in relation to more than one medical condition on the UPHN list, fees will only apply when the device is no longer related to any medical condition on the UPHN list.
Fees will not apply for:
- authorization holders of a Class II to IV medical device that amend their authorization to remove the medical condition it was initially authorized for and add a new medical condition for the device on the UPHN list; and
- authorization holders of a medical device that is not currently on the UPHN list if they amend their authorization to add a new medical condition that is on the UPHN list for their device.
As with the previously published Part 1.1 fee requirements, once medical devices are removed from the UPHN list, certain fee requirements will apply as follows:
- Class I medical devices: Authorization holders will continue to have 120 days to transition to Part 1 of the MDR where medical device establishment licence (MDEL) requirements will apply, including any associated fees.
- Class II to IV medical devices: Authorization holders will continue to need to pay fees for the examination of applications to amend an authorization and the annual right to sell fee.
Consistent with the previously published Part 1.1 fee requirements, if a Class II to IV medical device or category of medical device is added back on the UPHN list after the manufacturer started paying fees, future fees will not apply while the medical device is on the UPHN list in relation to the medical condition for which it was authorized. Any paid fees will not be reimbursed by Health Canada, nor will fees be charged retroactively.
For manufacturers with applications in queue, if the UPHN list is amended and their medical device or category of medical device is subsequently removed from the UPHN list, relevant fee requirements will only be triggered after they are issued an authorization.
Consequential amendments
Removing COVID-19 references
References to COVID-19 will be removed and references to COVID-19 medical device will be replaced by medical device to align with the term used in the amended Part 1.1 of the MDR to ensure that it reflects the broadened scope of any future public health emergency.
Exception under subsection 60 (1)
An exception provision will be introduced to ensure that amendment fees under subsection 60 (1) will not apply to amendment applications to add a new medical condition if that medical condition qualified the device as a UPHN medical device when the amendment was submitted. This change was required as a result of the broadening of Part 1.1 of the MDR where multiple medical conditions can be listed on the UPHN list. This provision applies for devices authorized under Part 1.1 that are no longer on the UPHN list for the medical condition(s) for which they were initially authorized.
Additional changes
The definition of performance standard will be revised with the new date of the Performance Standards for the Fees In Respect of Drugs and Medical Devices Order document, which has been updated to reflect the broadened regulatory framework under Part 1.1 of the MDR.
The Fees Order will make several minor amendments to better comply with standard approaches for regulatory drafting and to maintain consistency between the English and French texts.
Coming into Force
These amendments to the Fees Order will come into force on the day the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) come into force.
Regulatory development
Consultation
March-April 2023 (Notice of Intent)
On March 23, 2023, Health Canada posted a Notice of Intent on the Department’s website to solicit stakeholder feedback on the proposed amendments to broaden Part 1.1 of the MDR to include other public health emergencies beyond COVID-19. The Notice of Intent also included the proposed policy for fees. The consultation was open for a 21-day period and closed on April 13, 2023.
While comments were received from five industry stakeholders and associations, no feedback was received on the fees amendments.
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). As well, Health Canada 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.
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 proposal. The assessment did not identify any modern treaty implications or obligations.
Instrument choice
Fees for regulatory activities related to medical devices in Canada are charged as per the Fees Order. Introducing amendments to this instrument is the only option to achieve the Department’s objective to continue to charge fees to Part 1.1 authorization holders of medical devices that are no longer on the UPHN list.
Regulatory analysis
Benefits and costs
The cost to industry resulting from fees is balanced with equivalent savings to Canadian taxpayers creating a net $0 present value. The real benefits and costs of the package are related to the regulations and not to the Fees Order itself.
Small business lens
No disproportionate impacts on small businesses are expected.
Class II to IV medical devices
Some manufacturers may be eligible for existing small business fee mitigation, with a 25% reduction for all annual right to sell fees and a 50% reduction in all examination fees for amendments. Existing penalties and performance standards for medical device applications will apply as per the Fees Order.
One-for-one rule
The one-for-one rule does not apply because these amendments will not cause administrative burden to any stakeholders.
Regulatory cooperation and alignment
These amendments to the Fees Order are not related to a work plan or commitment under a formal regulatory cooperation forum.
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+)
No gender-based analysis plus (GBA+) impacts have been identified for this proposal.
Implementation and service standards
Forms and webpages will be updated to reflect the revisions to the Fees Order. Existing performance standards, as per the Performance Standards for the Fees in Respect of Drugs and Medical Devices Order will continue to be applicable, and the document will be updated to include the broadened regulatory framework under Part 1.1 of the MDR.
Contact
Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and 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