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).
- 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.