On Thursday December 27th, Health Canada detailed a new three-part method aimed to help safety, oversight and quality in the Canadian medical device market.
This plan has come soon after the investigation of the relationship between patient harm and surgically implanted medical devices, carried out by the International Consortium of Investigative Journalists. The investigation caused Ginette Petitpas Taylor, the current Canadian Minister of Health, to prompt Health Canada to address the medical device premarket approval processes, adverse event reporting and clinical data access.
This method hopes to advance how medical devices are brought onto the market and subsequently followed up with via post-market surveillance. In addition, the organization wants to make clinical data more publicly available, thus promoting greater transparency around the use of devices by patients.
Health Canada wants to encompass all perspectives, especially those that use medical devices in its new regulations and policies in 2019 and 2020. The three parts that comprise this plan each have their own general timelines, but there are specific deadlines for 2019 as seen below.
In order by month:
- 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: Hire eight more compliance inspectors and two investigational analysts. The focus should be on medical devices for the first meeting of the new women’s health scientific advisory committee.
- April: Increase foreign device manufacturing site inspections from 80 to 95.
- May: Past meetings have focused on digital health and cardiovascular devices. Now, the goal is to also have meetings with the women’s health scientific advisory committee.
- 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: Based on developments announced in June, publish a “What we Heard Report” and launch an educational program for healthcare facilities.
- November: Issue a draft guidance to strengthen requirements involving clinical documentation used for proof of safety and effectiveness as part of premarket submissions.
- December: To promote transparency in this space, a new accessible, user friendly and online database that contains medical device incident reports will be launched.
Along with these different milestones, the number of published summaries on approved license applications is set to reach more than 1,000 compared to the less than 100 published each year by Health Canada.
Health Canada medical device regulations: https://www.regdesk.co/cmdr/