Health Canada amends the Medical Devices Regulations to include mandatory shortage reporting
Medical Devices Compliance Program Bulletin, November 30, 2021
Health Canada has amended the Medical Devices Regulations (Regulations) making permanent regulatory provisions for medical device shortage reporting. The current provisions are found in Interim Order No. 2 Respecting Drugs, Medical Devices and Foods fora Special Dietary Purpose in Relation to COVID-19, which expires on March 1, 2022.
The amendments to the Regulations are published in Canada Gazette, Part II. The regulatory amendments come into force on March 1, 2022. Manufacturers of Class I to IV medical devices and importers of Class I medical devices will be required to report to Health Canada:
- actual or anticipated medical device shortages and
- medical device discontinuations
These reporting requirements are for devices belonging to a category of medical devices found on the List of medical devices - Notification of shortages, which is amended from time to time.
This bulletin is to inform manufacturers, importers and distributors that Health Canada has posted an amended draft guidance document for reporting medical device shortages and discontinuations. We are posting the amended draft guidance so that industry may become familiar with the amended regulations before they come into force.
You may send your comments or questions on the amended draft guidance to MD.shortages.Penurie.de.IM@hc-sc.gc.ca. Indicate "draft guidance comments" in the subject line. Please submit all questions or comments before January 7, 2022.
The final guidance document will be available on March 1, 2022, along with a medical devices compliance program (MDCP) bulletin.
Please note that until March 1, 2022, the current COVID-19 guidance for reporting medical device shortages (GUI-0137) remains in effect.
Health Canada continues to encourage the submission of shortage reports of medical devices, even if they are not on the List of medical devices - Notification of shortages. They may also be submitted through our electronic shortages reporting form. These voluntary reports help us determine trends in the medical device supply chain and where there are areas of risk or concern for shortages.
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