Medical Devices like pacemakers and insulin pumps, are essential to improving and maintaining the overall health and well-being of Canadians. Health Canada Medical Devices Regulations contain some of the strictest requirements globally for the use and licencing of medical devices. In Canada, medical devices are categorized into four classes based on the risk associated with their use, with Class I devices presenting the lowest potential risk (e.g. a tongue depressor) and Class IV devices presenting the greatest potential risk (e.g. a peacemaker).
The Regulations were founded on the approach that the safety and effectiveness of medical devices can best be assessed through pre-market scrutiny, post-market surveillance, and compliance and enforcement activities. Committed to the health and safety of Canadians, Canada’s Minister of Health has recently developed an Action Plan to accelerate its efforts to improve the strategy surrounding the regulation of medical devices in Canada and their use in real-time so that we remain world-class leaders in the safety and effectiveness of medical devices.
There are three parts to the proposed strategy of the action plan:
- improve how medical devices get on the market
- strengthen monitoring and follow-up for devices already in use
- provide Canadians with more information about the medical devices they rely on
The plan will push some existing initiatives:
- Publish Regulatory Decision Summaries which explain Health Canada ‘s decision to approve or reject the sale of Class III and Class IV medical devices on the Canadian market by January 2019;
- Increase the number of inspections of foreign medical device manufacturers, by April 2019.
- Advance final regulations to require hospitals to report medical device incidents to Health Canada, by June 2019.
- Align the medical device incident reporting with pharmaceutical products by proposing draft regulations requiring manufacturers to notify Health Canada within 72 hours if foreign regulatory agencies issue a warning about serious risks related to a medical device, by June 2019; and
- Make clinical information and data about medical device incidents more easily available, by December 2019.
The plan will also introduce new areas in:
- Broadening Health Canada’s use of independent scientific expertise, including creating a new expert advisory committee on women’s health issues for drugs and medical devices by January 2019;
- Introducing a proposal to allow healthcare professionals to conduct investigational testing of medical devices, by June 2019. Health Canada has also announced that it will launch an accessible database that will contain medical device incident reports in a user-friendly, searchable, online format by December 2019
Of course, all medical devices and healthcare products sold in Canada still must meet all the requirements of the Medical Device Regulations even if they are currently USA FDA or any other country health agency licenced.
Our in-house regulatory experts can help to ensure that your product receives the right classification and further to that, all licenses are met, and it enters the Canadian market in a quick and stress-free manner. Just reach out!
