Service Standards for Medical Device Submission Evaluations under the Medical Devices Regulations – Health Canada

Service Description:

Health Canada posts service standards and performance information for regulatory services with over 100 regulatory authorizations, such as permits or licences, issued each year (high-volume regulatory transactions).

The evaluation of medical device submissions is a service with a high volume of regulatory transactions used by industry and health care professionals for all medical devices imported or sold in Canada.

The Medical Devices Regulations set out the requirements governing the sale, importation, and advertisement of medical devices in Canada. Health Canada reviews higher risk medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada.

The guideline Management of Applications for Medical Device Licences and Investigational Testing Authorizations outlines the way Health Canada manages applications for medical device licences and applications for investigational testing authorizations submitted in accordance with the Medical Devices Regulations.

Service Standard:

The Health Products and Food Branch (HPFB) commits to service delivery standards for first review outlined as time in calendar days in the below-noted table.

Medical Devices - Service Standards	Time in Calendar Days
Non-Cost Recovered Submissions
Class II, III, IV-Investigational Testing Authorization Applications	30
Cost Recovered Submissions
Class II - Licence Application	15
Class II - Amendment Licence Application	15
Class III - Licence Application	60
Class III - Licence Application (Near Patient In Vitro Diagnostic Devices)	60
Class IV - Licence Application	75
Class III - Changes in Manufacturing	60
Class IV - Changes in Manufacturing	75
Class III - Significant Changes (not related to Manufacturing)	60
Class IV - Significant Changes (not related to Manufacturing)	75
Class II, III, IV-Private Label Applications	15

Performance Target:

The target for the average time to reach first decision on a submission within an individual fee line is given in the above table.

Performance result in fiscal year 2020 to 2021:

Annual service performance is measured over the course of the fiscal year (April 1 - March 31). Performance results for a given fiscal year are published in the Report on Fees, which is normally tabled in Parliament and published in the third quarter (October-December) of the following fiscal year.

In 2020-2021, HPFB's actual results for these submissions are:

Medical Devices - Results	Performance Result
Non-Cost Recovered Submissions
Class II, III, IV-Investigational Testing Authorization Applications	90%
Cost Recovered Submissions
Class II - Licence Application	99%
Class II - Amendment Licence Application	98%
Class III - Licence Application	100%
Class III - Licence Application (Near Patient In Vitro Diagnostic Devices)	100%
Class IV - Licence Application	98%
Class III - Changes in Manufacturing	100%
Class IV - Changes in Manufacturing	100%
Class III - Significant Changes (not related to Manufacturing)	99%
Class IV - Significant Changes (not related to Manufacturing)	100%
Class II, III, IV-Private Label Applications	98%

Departmental Contacts:

Please contact the Licensing Program to make any general inquiries or comments:

Bureau of Licensing Services
Medical Devices Directorate (MDD)
Health Canada
11 Holland Avenue, Tower A 2nd Floor
Address Locator: 3002A
Ottawa, Ontario
K1A 0K9
Phone: 613-957-7285
E-mail:  meddevices-instrumentsmed@hc-sc.gc.ca

Cost Recovery:
E-mail:  cro-brc@hc-sc.gc.ca
Telephone: 613-617-7323
Fax: 613-954-9981