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.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
Related Publications & Articles
-
Federal Court of Appeal dismisses appeal of SPRAVATO “innovative drug” decision
On November 10, 2021, the Minister of Health refused to reassess its decision that Janssen’s esketamine hydrochloride product (SPRAVATO) was not an “innovative drug” and therefore not entitled to data...Read More -
CIPO will not issue patents on July 9 or July 16
The Canadian Intellectual Property Office (CIPO) will be launching a new online portal for patent services, MyCIPO Patents, on July 15, 2024.Read More -
2024 mid-year highlights in Canadian life sciences IP and regulatory law
In the first half of 2024, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories ...Read More