Consultation on amendments to regulations to import and sell COVID-19 medical devices

On this page

• Who was the focus of this consultation
• Key items for discussion
• What was heard

The purpose of this consultation was to engage with stakeholders on the proposed changes to the Medical Devices Regulations (MDR). Changes were proposed so that COVID-19 medical devices may continue to be imported and sold after the expiry of Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 3).

We were also seeking feedback on the proposed changes and fee implications, outlined in the Notice of intent on the proposed changes to the MDR to continue the importation and sale of COVID-19 medical devices.

Who was the focus of this consultation

We engaged with:

• medical device stakeholders
• medical device establishment licence holders
• current interim order authorization holders under IO No. 3

Key items for discussion

We were seeking your feedback on the proposed measures and the fee implications outlined in the notice.

In particular:

• If you have terms and conditions on the authorization of your medical device under the interim order, provide the number of terms and conditions by class on a per product basis.
• Indicate whether you currently have a quality management system (QMS) certificate issued under the Medical Device Single Audit Program (MDSAP) under the MDR.
• If you have a QMS certificate issued under MDSAP under the MDR, indicate the costs and processes for obtaining one and how long it took to get a certificate.
• If you don't have a QMS certificate issued under MDSAP, indicate your anticipated costs and processes for obtaining one.
• Based upon what is described in the proposal, indicate whether you would continue to market your COVID-19 product in the Canadian market.
• Indicate the factors that will contribute to your decision to continue or discontinue that product.

We also wanted your ideas and input on the:

• challenges anticipated in complying with the requirements
• useful measures to help overcome any challenges
• concerns about fees

The input that was gathered through this process will help us refine the proposal and develop the related content.

What was heard

In general, stakeholders supported the proposed changes and no major concerns were raised. However, stakeholders sought clarification on the following items:

• implementation details on the proposed annual authorization requirements
• process for new submissions
• amendment applications, specifically if there are significant changes
• quality management system (QMS) certificates
• the type of licence issued once a device is no longer on the UPHN list

Stakeholders advocated for:

• better-defined criteria to determine an urgent public health need (UPHN)
• a pathway for Class I medical devices separate from Class II, III and IV devices, similar to the existing licensing scheme under the MDR
• broadening the authorization pathway to other "declared pandemic or health emergency" situations rather than for COVID-19 only

Next steps

Health Canada is grateful for the feedback received on the proposal. The feedback will help inform the guidance document that will accompany the regulations.

We will address process-based questions in the guidance document, which will be published at the same time as the regulatory package. For example:

• UPHN will be further defined in the guidance to provide clarity to applicants and authorization holders and to ensure consistent application among Health Canada reviewers.
• The requirement for Class I manufacturers to obtain an MDEL under the MDR once the device is no longer on the UPHN list will be clarified in the proposed regulations.
• The request to broaden the scope to include other declared pandemics or health emergency situations may be considered at a later date.

Related information

• Food and Drugs Act

Contact us

Email: mddpolicy-politiquesdim@hc-sc.gc.ca