Health Canada Details Medical Device Action Plan

Regulatory NewsRegulatory News | 20 December 2018 |  By 

Health Canada issued a new action plan on Thursday, detailing a three-part strategy intended to improve safety, oversight and quality in the Canadian medical device ecosystem.
The move follows on the heels of an International Consortium of Investigative Journalists investigation into patient harm linked to surgically implanted medical devices. The investigation prompted the Canadian Minister of Health to call on Health Canada to address premarket approval processes, adverse events reporting and access to clinical data on medical devices. 
The strategy seeks to improve how devices are introduced to the market as well as postmarket surveillance and follow-up on patient use. The third prong promotes transparency around patients’ use of devices by making more information, including clinical data, publicly available.
Health Canada intends to be more inclusive of “all perspectives, particularly those who use medical devices,” in the policies and regulations to pursue in fiscal year 2019 and 2020. Each of the three parts has rough timelines, but most milestones include more specific deadlines. In chronological order, the regulator plans on tackling 2019 milestones as follows: 
January: call for members to form a new scientific advisory committee on women’s health issues for drugs and medical devices; begin publishing de-personalized data extract files on medical device incidents, complaints and recalls; increase the number of published summaries on approved license applications by expanding from the current class IV limit to include class III. 
March: focus the first meeting of the new women’s health scientific advisory committee on medical devices; hire eight more compliance inspectors and two investigational analysts.
April: increase the number of foreign device manufacturing site inspections from 80 to 95. 
May: hold a meeting of the women’s health scientific advisory committee. Other meetings have focused on digital health and cardiovascular devices. 
June: issue a notice of intent on changes to allow care professionals and researchers conduct investigational testing of medical devices; publish Regulations to Report Medical Device Incidents in Canada Gazette, Part II; publish draft regulations to “bring mandatory reporting to Health Canada from zero to 776 hospitals;” expand the Canadian Medical Devices Sentinel Network to include long-term care facilities and private clinics; establish a real-world evidence approach for regulatory decision-making; implement new regulations to release clinical data.
September: publish a “What we Heard Report” based on changes announced in June to allow medical device investigational testing; launch an educational program for health care facilities. 
November: issue draft guidance to strengthen requirements around the type of clinical evidence used to demonstrate safety and effectiveness as part of premarket submissions. 
December: launch a new “accessible database that contains medical device incident reports in a user-friendly, searchable, online format” to promote confidence in the regulatory system.
There are nearly 20 different milestones and the planned push to promote compliance with adverse event reporting requirements is the only one set for fiscal year 2019 and 2020. Also of note, the number of published summaries on approved license applications is expected to reach more than 1,000 summaries compared to less than 100 currently published by Health Canada per year.  
“Collaboration with provinces and territories, and other healthcare system partners will be fundamental to delivering results,” Health Canada said. The regulatory authority added that it also intends to “strengthen and expand existing outreach and information activities, as appropriate, to reinforce these important partnerships” as part of its new action plan.   
Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality


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