Consultation: Pre-market Requirements for Medical Device Cybersecurity

From Health Canada

Current status: Open

Opened on December 7, 2018 and will close to new input on February 5, 2019.

The purpose of the consultation is to seek stakeholder feedback on the technical considerations related to cybersecurity of medical devices and the submission requirements for a medical device licence.

Join in: how to participate

1. Read the draft guidance document
2. To make yourself heard, send an email to Bureau of Policy, Science and International Programs at hc.policy.bureau.enquiries.sc@canada.ca with your ideas or comments.

Who is the focus of this consultation

We will engage with the Medical Device Industry.

Feedback from the consultation

Your ideas and input are sought around cybersecurity of medical devices and the submission requirements for a medical device licence. The input gathered through this process will be used to finalize the guidance document.

Contact us

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Tower B
1600 Scott St.
Address Locator 3102C3
Ottawa, Ontario 
K1A 0K9

Telephone: 613-957-1058
Email: hc.policy.bureau.enquiries.sc@canada.ca