Notice of Intent – Health Canada to confirm its priority review request process of medical device applications and eligibility criteria

November 21, 2018
Our file number: 18-117630-749

Context

Medical devices applications are generally processed and reviewed in the order they are received by the Medical Devices Bureau (MDB).

However, under the Interim Policy on Priority Review of Medical Device Licence Application issued in 2000, a preferential prioritization system was introduced for the review of some Class III or IV medical device licence applications intended for the diagnosis or treatment of a serious, life-threatening or severely debilitating disease or condition when there is substantial clinical evidence that the medical device provides:

  • Effective treatment or diagnosis of a disease or condition for which no medical device is currently licenced in Canada; or
  • Significant risk-benefit improvement over existing therapeutic or diagnostic devices for a disease or condition that is not adequately managed by existing products marketed in Canada.

Review of the Interim Policy on Priority Review of Medical Device Licence Applications

Health Canada has reviewed the Interim Policy on Priority Review of Medical Device Licence Applications in the context of the overall government’s initiative to modernize Canada’s regulatory framework.

Health Canada concluded that while the intent of the interim policy, to provide faster access for Canadians to new medical devices for serious, life-threatening or severely debilitating diseases or conditions is still relevant, the existing request process is unnecessarily complex. Health Canada also acknowledges that consideration should be given to unforeseen or unmet urgent health need (e.g. in the context of a pandemic) in granting priority review.

Proposed changes to the administrative process for requesting priority review and eligibility criteria

In order to streamline the priority review request process, Health Canada intends to incorporate a priority review request option in the new and amendment medical device licence application forms - there will no longer be a requirement for a separate request/form.

Priority review will be granted to a Class III or IV medical device licence applications intended for the diagnosis or treatment of a serious, life-threatening or severely debilitating disease or condition when there is substantial clinical evidence that the medical device:

  • Provides effective treatment or diagnosis of a disease or condition for which no medical device is currently licenced in Canada;
  • Provides significant risk-benefit improvement over existing therapeutic or diagnostic devices for a disease or condition that is not adequately managed by existing products marketed in Canada; or,
  • Responds to an unforeseen or unmet urgent health need. (New)

Applications requesting priority review will be screened in accordance with the standard 15 day performance target, but reviewed in priority when meeting the above criteria. Depending on the complexity of the application or the novelty of the product, this might lead to a shorter time to market, but ultimately the existing fees and service standards for review of Class III and IV licence applications will apply (i.e. 60 and 75 days). Applicants will be notified at screening acceptance whether their application was accepted for priority review.

Comments relating to Health Canada’s streamlined priority review application process should be directed to the Medical Devices Bureau by January 25, 2019.

Medical Devices Bureau - General Inquiries
hc.mdb.enquiries-enquetes.bmm.sc@canada.ca
Telephone: 613-957-4786
Fax: 613-957-6345
Teletypewriter: 1-800-465-7735 (Service Canada)

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: