Share your views: Consultation on amendments to regulations to import and sell COVID-19 medical devices
Current status: Open
Opened on May 2, 2022, and will close to new input on May 22, 2022.
Health Canada wants your feedback on the proposed changes to the Medical Devices Regulations (MDR). Changes are being 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 are also seeking feedback on the proposed changes and fee implications.
- Review our Notice of intent on the proposed changes to the MDR to continue the importation and sale of COVID-19 medical devices.
Join in: how to participate
Send us an email
Send an email to email@example.com with your ideas or comments to make yourself heard.
Who is the focus of this consultation
We are seeking comments from:
- medical device stakeholders
- medical device establishment licence holders
- current interim order authorization holders under IO No. 3
Key items for discussion
We are seeking your feedback on the proposed measures and the fee implications outlined in the notice.
- 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 want your ideas and input on the:
- challenges anticipated in complying with the requirements
- useful measures to help overcome any challenges
- concerns about fees
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