Health Canada's Annual Regulatory and Quality Conference: A personal digest

In a recent LinkedIn post, I spoke about Health Canada’s plan to make the REP (Regulatory Enrolment Process) mandatory 18 months after its projected implementation date (January 2024). In another post, I summarized the list of proposed amendments to the Canadian Medical Device Regulation, for which the public consultation closed on June 29th.

Today, and with the start of the 156th Canadian year, comes a summary of my key take-aways from attending the Annual Health Canada Regulatory and Quality Conference co-organized with Medtech Canada. 

Breast implant initiative

With patients, parliamentarians and Doctors calling for the creation of a Canadian Breast Implant registry. It was great to hear Health Canada’s plan to raise awareness on Breast Implant induced lymphoma and update their website. 

Currently, #HealthCanada’s website states these devices are safe and their benefits outweigh their risk, which was puzzling to me personally as Mr. David Boudreau acknowledged a rise in observed Breast Implant Associated Lymphoma (BIA-ALCL). Currently, breast implants have the highest risk classification (Class IV) in Canada under Rule 16. 

MDSAP 

With the UK hashtag#MHRA seriously considering to implement the MDSAP platform, Mexico and Taiwan applying to join as observers, I am very pleased to see #Canada’s quiet leadership having quiet ripples and affecting quiet (but meaningful) change. Hopefully, a quiet nudge to Europeans to harmonize.

So far, the EU has been a simple observer of the single audit program and has made shy moves towards using MDSAP audit reports (ref. MDCG 2020-14). The Irish Auditing Organization and Notified Body, National Standards Authority of Ireland (NSAI), explained that the initial EU-MDR audit cannot be combined with MDSAP surveillance or re-certification audits, which significantly impacts AO's capacity in Canada.

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