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Health Canada (HC) has one of the most stringent regulations for medical devices. To further increase the safety and effectiveness of devices, and optimize the health outcomes for end-users, the Canadian health authority (HA) is aiming to strengthen the current Regulatory framework. The three-part strategy announced recently as an action plan is the part of the same. The aim of the action plan is to take the end-users’ perspective into consideration while developing policies and regulations in future and thus to improve communication.
Each one of the three parts of the proposed medical device action plan has a sub-set of activities with approximate timelines. In order to successfully complete these activities, HC has also set milestones to ensure the objectives are achieved. All the three steps with necessary milestones are listed below.
1. Improve how devices get on the market
- Increase research by medical professionals and increase patient protection – starting early 2019
Milestones:
i. Note of intent – June 2019
ii. What we heard report – September 2019
- Review evidence requirements and expand scientific expertize – starting January 2019
Milestones:
i. Call for members for the new Expert Advisory Committee on Women’s Health – January 2019
ii. Meeting of Scientific Advisory Committee – March and May 2019
iii. Draft guidance document on evidence requirements – November 2019
2. Strengthen monitoring and follow-up
- Implement mandatory reporting and expand the Canadian Medical Devices Sentinel Network – starting February 2019
Milestones:
i. Publishing of regulations to report medical device incidents in Canada Gazette, Part II – June 2019
ii. Expansion of CMDSNet to include additional healthcare settings outside hospitals, such as long-term care facilities and private clinics – June 2019 and ongoing
iii. The launch of education program for other healthcare settings – September 2019
- Establish ability to compel information on medical device safety and effectiveness and expand the use of real-world evidence – starting early 2019
Milestones:
i. Publishing of Draft Regulations in Canada Gazette, Part I – June 2019
ii. Establish how real-world evidence will be used for Regulatory decision-making – June 2019
- Enhance capacity for inspection and enforcement – starting 2019
Milestones:
i. Hiring of additional 8 inspectors and 2 investigational analysts – March 2019
ii. Increase in the number of foreign inspections from 80 to 95 – April 2019
iii. Increase in compliance promotion activities – fiscal year 2019/2020
3. Provide more information to Canadians
- Improve access to medical device clinical data – finalized by early 2019
Milestones:
i. Publication of regulations in Canada Gazette, Part – II – June 2019
ii. Launch of searchable public web portal - Following publishing in Canada Gazette, Part II
- Increase the information on device approvals and publish medical device incident data – starting January 2019
Milestones:
i. Publishing and regularly updating a de-personalized data extract file of medical device incidents, complaints and recalls – January 2019
ii. The launch of publishing of more review decision summaries – January 2019
iii. Publishing searchable medical device incident database – December 2019
The year ahead might be dynamic with multiple activities proposed in the action plan. Aligning with the possible amendments, device manufacturers marketing their products in Canada must be prepared. Increase in Regulatory scrutiny being the foremost result of the strategy, stakeholders should be quick in adapting to the new changes on the go. But to know the full scope of amendments, consulting a Regulatory expert will prove beneficial. Stay informed. Be compliant.
