New transition regulations for the Interim Order Respecting the Importation and Sale of Medical Devices (COVID-19): Notice to stakeholders

Date published: November 27, 2020

Health Canada created the interim order respecting the importation and sale of medical devices for use in relation to COVID-19 to accelerate access to medical devices in Canada during the COVID-19 outbreak. We plan to bring forward regulatory amendments that would allow many of the flexibilities under the interim orders (IOs) to continue after the IO expires. These transition regulations will ensure that medical devices authorized under the IO can continue to be sold, imported or distributed in Canada.

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Overview

The IO provides a streamlined regulatory process to authorize the importation or sale of medical devices used to diagnose, treat, mitigate or prevent COVID-19, while maintaining safety standards. It expires on March 18, 2021. However, Health Canada intends to introduce a second interim order to maintain the flexibilities and regulatory oversight provided by the current IO until at least the fall of 2021.

To allow COVID-19 devices authorized under the IO to continue to be imported and sold, Health Canada is also developing transition regulations so that people can continue to have access to the COVID-19 medical devices they need.

These proposed transition regulations would take effect when the second interim order ends in the fall of 2021 and would remain in place for 2 years. During this time, manufacturers, importers and distributors would have an opportunity to transition from a COVID-19 IO authorization to a regular medical device licence or a Medical Device Establishment Licence (MDEL).

To seek stakeholder views on the proposed policies under the second interim order and the transition regulations, Health Canada is consulting with those affected, starting in November. The consultation will be open for about 3 weeks, after which we will review and consolidate responses. Your input will help us refine the proposals and develop the accompanying guidance document.

Health Canada will continue to monitor COVID-19 devices on the market. We will take action if safety, effectiveness or quality issues pose a risk to people.

Policy changes to be proposed under the second interim order (March 2021 through fall 2021)

Following the introduction of the second interim order in March 2021:

Proposed transition plan for IO authorizations after the fall of 2021

For Class I medical devices  

Manufacturers of Class I devices authorized under the IO would be able to continue importing their device under a temporary Class I licence for 18 months after the coming into effect of the transition regulations. To continue to sell after 18 months, manufacturers would need to either obtain an MDEL or import/sell that device solely through an MDEL holder. The fees for reviewing an application for an MDEL would be charged as set out in the fees for drugs and medical devices order.

For Class I COVID-19 device applications that have not received a decision by the time the transition regulations come into effect, Health Canada would continue to review the applications against the IO criteria. If the application is successful, the device would be given a temporary Class I licence. Manufacturers would still need to seek an MDEL or import/sell their device solely through an MDEL holder by the end of the 18 months.

For Class II, III and IV medical devices

When the transition regulations come into effect, active authorizations granted for Class II, III and IV devices would be deemed medical device licences under the Medical Devices Regulations (MDR) for up to 2 years. Manufacturers of these devices will be able to ‘opt out’ if they do not want a deemed medical device licence.

Manufacturers would be issued a regular medical device licence only after they have met the following requirements and submitted the relevant information to Health Canada for review. By the end of the 2-year period, manufacturers should:

Manufacturers of Class III and IV devices may also be asked to submit additional evidence, building on information already submitted under the IO. For example, this could include additional clinical evidence, a marketing history report or an assessment of post-market data.

Health Canada will be actively monitoring devices transitioning to the regular regulatory framework during and beyond the 2-year period. Manufacturers would be required to comply with post-market requirements, including complaint handling and incident reporting.

When a regular medical device licence is issued under the MDR, manufacturers will start paying medical device right-to-sell fees, as set out in the fees for drugs and medical devices order. Manufacturers that wish to make amendments to their COVID-19 medical devices during the transition period would be charged an amendment fee, as described in the order.

For manufacturers of Class II, III and IV devices that have applied for an IO authorization but have not received a decision by the time transition regulations take effect, Health Canada would continue to review their pending applications against the IO criteria. If the application is successful, the device would be issued a transitional medical device licence, valid for a period up to the end of the 2-year transition period. Manufacturers would still need to fulfill all of the requirements before the transition regulatory period ends in order to continue importing or selling their device after the end of that period.

Next steps

Health Canada will consult by email with stakeholders who are affected by the proposals, starting in November. We will use this feedback to refine the proposals and develop the draft guidance document. We will consult on the draft guidance document in the winter.

Contact us

For more information or to provide comments or questions about this notice, please contact Health Canada’s Medical Devices Directorate at hc.mddpolicy-politiquesdim.sc@canada.ca.

For more information on medical device establishment licensing, please contact us by email at hc.mdel.questions.leim.sc@canada.ca.

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