Notice: Guidance Document - Pre-market Requirements for Medical Device Cybersecurity

June 26, 2019
Our file number: 19-111412-287

Health Canada is pleased to announce the finalization of the guidance document on Pre-market Requirements for Medical Device Cybersecurity.

The guidance document provides medical device manufacturers with advice on the practices, responses and mitigation measures which can improve the cybersecurity of their device. The draft version of this document was posted to the Health Canada website on December 7, 2018 for a 60-day consultation. Stakeholder comments received on the draft version of this document were considered in the finalization of this guidance document. A summary of comments received is available upon request.

This guidance document is effective immediately.

Please direct questions or concerns regarding this guidance document to:

Device Licensing Services Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
11 Holland Avenue
Address Locator: 3002A
Ottawa, Ontario
K1A 0K9

Email: devicelicensing-homologationinstruments@hc-sc.gc.ca
Telephone: 613-957-7285