top of page
Search

Canada: Health Canada Revised Guidance on Medical Device Establishment Licensing (GUI-0016)

  • Writer: ARQon
    ARQon
  • Sep 8, 2023
  • 3 min read

Effectively on the issuance date, 6 September 2023, Health Canada released a few key changes in the guidance on Medical Device Establishment Licensing (GUI-0016).


Licenses for Medical Devices

2 types of licenses issued by Health Canada for medical devices, which are Medical Device License (MDL) and Medical Device Establishment Licensing (MDEL).

It is likely to remind the license holders to submit an annual license review application before 1 April each year and notify Health Canada within 15 calendar days of any changes to the information.


MDEL Requirement and Exemption Types

As stated above, the MDEL license is issued only to Class I manufacturers and importers/distributors for all classes of medical devices as the permit to distribute or import their own medical devices in Canada. Below are the requirements that oblige the person to acquire the MDEL license:

  • Buy/import medical devices from outside of Canada with foreign manufacturers/distributors already licensed with MDEL and sell in Canada

  • Buy/import medical devices from Canada and outside of Canada, to sell the medical device in Canada

  • The person who is located outside of Canada only to sell, not manufacture, the medical devices to the importers, healthcare facilities, and/or retailers in Canada

  • The person who manufactures and sell Class I medical device, named as the manufacturer on the label, in Canada

  • The person who is located outside of Canada, only sell Class I medical device named as the manufacturer, in Canada

However, there are some conditions that exempt the persons from acquiring the MDEL license for import/sell activity in Canada:

  • Manufacturers of Class I medical devices that import/distribute through persons who acquire MDEL, only can import/sell their own medical device

  • Manufacturers of Class II, III, and IV medical devices that acquire valid MDL

  • Dispensers, healthcare facilities with therapeutic or diagnostic services to the patients

  • Retailers, manufacturers of Class I medical devices in Canada (who only sell to the end users)

  • Persons who import/sell medical devices for animal use only

  • Importer/seller for medical devices subject to Part 2 and Part 3 in the MDR (custom-made devices, special access medical devices, clinical trials with human subjects medical devices)

  • Warehouses with the purpose of medical device storage and no buy, sell, or consign activity

  • Persons who import medical devices for personal use

Responsibility of MDEL Holders (Foreign Risk Notification (FRN))

MDEL/MDL holders, importers, or Investigational Testing Authorization holders of Class II, III, and IV are required to notify Health Canada of the serious injury to human health concerning medical devices authorized for sale in Canada when:

  • Notifiable actions are taken by the foreign regulators of certain jurisdiction

  • The authorization holders take the notifiable actions under certain foreign jurisdiction

The notifiable actions mentioned above include public risk communication, labeling change requested by foreign regulatory agencies, recall, authorization reassessment, suspension, or authorization revocation.


FRN report must be submitted to Health Canada via email when serious risk of injury to human health happens, concerning Class II, III, and IV of medical devices authorized for sale in Canada, notifiable action has been taken to eliminate the serious risk, and the action took place under the jurisdiction of any of the regulatory agencies. The manufacturers or importers must submit within 72 hours after the incident report is received by the authority or in the awareness of the notifiable actions.

Amendment Submission Timeline Outside the Annual License Review Period

For any amendment involving the MDEL information, for instance, the manufacturers’ list, activities, or classes of devices, the person must submit the changes to Health Canada through the Annual License Review (ALR) application, also before your license is updated.

If the amendment has to be made before the next ALR, it can be made through an amendment application using FRM-0292, only from 1 April to the mid-November of that year.

The changes that require to notify Health Canada are:

  • Changes to the name or address of the establishment

  • Changes to the representative information associated with the MDEL application.

Health Canada also added a reminder for the applicants to settle their application fee payment within 30 days, or else the application will be rejected as non-payment.


Health Canada will issue an invoice after the application is complete and sponsors can make payment after receiving the invoice. Once the payment is done, Health Canada will proceed with the assessment and content evaluation for the application.



Contact us at info@arqon.com for more information.

 
 
 

Comments

bottom of page