Consultation Notice for Draft Guidance Document – Pre-market Requirements for Medical Device Cybersecurity

December 7, 2018
Our file number: 18-119254-906

Health Canada is pleased to announce the release of the Draft Guidance Document Pre-market Requirements for Medical Device Cybersecurity for a 60-day comment period.

This draft guidance document provides medical device manufacturers advice on the practices, responses and mitigation measures which can improve the cybersecurity of their device. This guidance also outlines the information to be submitted as part of a medical device licence or licence amendment application to demonstrate that their medical device, consisting of or containing software, is sufficiently secure from intentional or unintentional unauthorized access.

Comments on this draft guidance document should be submitted within 60 calendar days to the contact below:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
Ottawa, Ontario
K1A 0K9

Facsimile: 613-941-1812
E-mail: hc.policy.bureau.enquiries.sc@canada.ca