On 23 December 2020, new Post-Market Surveillance (PMS) requirements for Medical Devices were published in the Canada Gazette, Part II (CGII), amending the Medical Devices Regulations.
Why they should be introduced new PMS requirements for Medical Devices?
Health Canada explains that the new PMS requirements are intended to strengthen the life cycle approach to the regulation of Medical Devices, to improve the ability to assess and manage new risks for devices used in Canada.
Amendments provide for the strengthening of Post-Market Surveillance authorities, the implementation of additional measures to improve safety, quality and effectiveness of devices once the device has been placed on the market.
Changes affect both the holders of the Medical Device Application Licence (MDAL) and the holders of the Medical Device Establishment Licence (MDEL).
In summary, the most important new requirements:
1. Safety and efficacy analysis to determine whether the device meets the requirements (section 25 (1) and section 39).
2. Obligation to notify Health Canada of any serious risk of injury to human health (from section 61.2 to section 61.3).
➡️ June 23, 2021 (6 months after publication in the Canadian Official Gazette) date of entry into force of point 1 and point 2.
3. Annual drafting of summary reports for Class III and IV devices, every two years for Class II devices (from section 61.4 to section 61.6).
➡️ December 23, 2021 (12 months after publication in the Canadian Official Gazette) date of entry into force of point 3.
Are you the holder of a MDAL or MDEL license?
Contact us to schedule a consulting. Thema experts are at your disposal to help your company to correctly implement the PMS requirements.
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Canada Gazette, Part II (CGII)