Further to Health Canada’s “Action Plan on Medical Devices” (previously reported here), Health Canada has released the following:
- Notice: Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality - Informing Canadians about medical device treatment options – Further to Part III of the Action Plan on Medical Devices, Health Canada has begun to publish Regulatory Decision Summaries for Class III medical device licenses (e.g. orthopedic implants and blood glucose monitors) starting January 31, 2019 on Health Canada’s Drug and Health Product Register.
- Scientific Advisory Committee on Medical Devices Used in the Cardiovascular System – Announcement of Meeting – March 1, 2019 – On February 1, Health Canada issued a Notice announcing an upcoming meeting of Health Canada’s Scientific Advisory Committee on Medical Devices used in the Cardiovascular System. Health Canada stated that advice received from this meeting will be used to facilitate and enhance the review process for medical devices used in the cardiovascular system.
- Scientific Advisory Committee on Health Products for Women (SAC-HPW): Nomination Call for Members – On January 30, 2019, Health Canada published a nomination call for members for an external Scientific Advisory Committee on Health Products for Women (SAC-HPW). The SAC-HPW will provide advice on issues regarding women’s health and regulation of medical devices and drugs.
- Consultation on Draft Guidance Document for Software as a Medical Device (SaMD) – Health Canada has developed the Draft Guidance to better define regulatory compliance requirements for emerging technologies. Consultation on the Draft Guidance Document closes on March 29, 2019.