Notice: Regarding the Disclosure of Information on Medical Device Licence Applications Submitted to Health Canada

March 31, 2017
Our file number: 17-17-103060-818

The purpose of this Notice is to clarify Health Canada's position regarding the release of information about applications not filed. The Medical Devices Bureau (MDB) frequently receives requests about the status of a particular medical device licence application. In cases where a medical device licence application was submitted to Health Canada, MDB respects the manufacturer's wishes as declared in the License Application Disclosure Request. This disclosure request is part of the Medical Device Licence Application Form, where manufacturers can choose to consent to Health Canada's disclosing the date on which MDB received the licence application. In cases where no application is submitted, MDB typically does not confirm whether the application has been submitted.

Effective immediately, when an inquiry is made about an application that has not been submitted to Health Canada, MDB will inform the requester that Health Canada has not received that particular medical device licence application.

In instances where an application has been submitted to Health Canada, MDB will continue to respect the manufacturer's wishes of disclosure as per the current Medical Device License Application Disclosure Request.

For questions regarding the content of this notice, please contact:

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

Telephone: 613-948-4623
Fax: 613-941-6458
E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca