Health Canada Issues New Medical Device Recall Guide

Health Canada on Thursday issued new guidance on the medical device recalls in detail the responsibilities of sponsors under the Medical Devices Regulations (MDR) in the country, replacing the 2011 Guidelines of the organization.

Specifically, the guide provides advice on keeping medical records distribution, extraction devices instruments, submission to Health Canada recalls and drafting internal procedures for retirement.

The guide has also been rewritten to include support clubs and other language intended to provide clarity and other fund sponsors, including links to definitions, laws and regulations.

For example, in the section on the scope of the document, the agency added an explanation of why the regulatory requirements for reminders apply to different types of businesses:

The requirements to maintain distribution records under [section] 52-56 [Regulation of Medical Devices] and the recovery process in accordance with paragraph 58 (b) of the MDR (Part 1) s' apply to manufacturers, importers and distributors. The information requirements provided for in Articles 64 and 65 manufacturers and importers apply only.

The new guide also focuses more on the process and responsibilities related to the removal of the devices, while the previous version was more technical in nature, focusing on the different sections of the MDR and interpretation.

The new guide also includes additional annexes containing tables and checklists to carry out withdrawals and maintain distribution records.

Finally, the new guide includes detailed instructions for writing retirement procedures and reports of memory sections.