Posted 04 November 2016
By Michael Mezher
Health Canada on Thursday issued a new guide on medical device recalls detailing sponsors' responsibilities under the country's Medical Devices Regulations (MDR), replacing the agency's 2011 guidance.
Specifically, the guide provides advice on keeping medical device distribution records, recalling devices, reporting recalls to Health Canada and writing internal procedures related to recalls.
The guide has also been rewritten to include callout boxes and additional language intended to provide more clarity and additional background for sponsors, including links to relevant definitions, laws and regulations.
For instance, under the section on the document's scope, the agency adds an explanation for which regulatory requirements for recalls apply to different types of companies:
"Not all medical devices recall requirements apply to all companies working with medical devices. The requirements to maintain distribution records under [sections] 52-56 [of the Medical Devices Regulation] and to have a recall procedure under 58(b) of the MDR (Part 1) apply to manufacturers, importers and distributors. Recall reporting requirements under sections 64 and 65 apply only to manufacturers and importers."
The new guide is also more focused on the process and responsibilities related to device recalls, whereas the previous version was more technical in nature, focusing on the individual sections of the MDR and their interpretation.
The new guide also includes additional appendices featuring flow charts and checklists for conducting recalls and maintaining distribution records.
Lastly, the new guide features detailed sections for writing recall procedures and recall reports.