On June 15, 2019, the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Post-market Surveillance of Medical Devices) (Regulations) were pre-published (see news release here). These proposed changes are made in accordance with Vanessa’s Law (see updated chart here).
The proposed Regulations would implement changes to the Food and Drug Regulations and Medical Devices Regulations, and, among other matters, would:
- establish a regulatory framework to require assessments, tests and studies of medical devices;
- support post-market safety through imposing notification requirements for foreign incidents which must be reported within 72 hours for medical devices; and
- require medical device licence holders to prepare annual summary reports and supporting information, related to adverse effects, reported programs, incident, and risks, similar to a provision in the Food and Drug Regulations.
Any comments are due on August 26, 2019.
Further updates: On May 29, 2019, Health Canada published amendments to the Management of Applications for Medical Device Licences Guidance Document, which was rewritten, including to update and conform to Good Guidance Practices.