Health Canada releases Medical Devices Action Plan
On December 20, 2018, Health Canada published an Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality. The Action Plan states that despite existing regulations, more can be done to improve the safety and effectiveness of medical devices, and optimize health outcomes. The Action Plan is set out through a three-part strategy, all with 2019 milestones for at least initial steps towards implementation:
1. Part I: Improving how devices get on the market, including by:
a. increasing research by allowing health professionals and researchers to file an application for authorization to conduct investigational tests, and
b. reviewing evidence requirements related to higher-risk medical devices to strengthen evidence requirements for devices based on previously authorized versions and expanding scientific expertise, including by creating a new expert advisory committee on women’s health issues for drug and medical devices;
2. Part II: Strengthening monitoring and follow-up of devices, including through:
a. proposed regulations under Vanessa’s Law introducing mandatory reporting by Canadian hospitals (see here for our previously published article on the June 2018 proposed amendments),
b. proposed regulations under Vanessa’s Law to compel manufacturers to conduct assessments, tests and studies and improved reporting from healthcare facilities besides hospitals (e.g., long-term care facilities), and
c. enhancing capacity in inspection and enforcement; and
3. Part III: Providing more information to Canadians about the medical devices they use, including through:
a. implementing regulations governing the release of clinical trial data for medical devices (see here for our previously published article on the December 2017 proposed amendments), and
b. increasing information published on approvals (expanding to Class III, in addition to Class IV approvals) and medical device incident data through launch of a searchable database.
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