Canada increases the medical device license review fee, which takes effect in April
Canada has strict guidelines and is one of the best medical device regulatory systems in the world. As one of the few countries in the world that do not need to assign local representatives, Canada is very attractive to many foreign manufacturers. In addition, as one of the original member countries of GHTF (Global Medical Device Coordination Working Group), Canada’s certified products have been recognized in many countries such as Southeast Asia, the Middle East, South America and Africa, or can help to quickly review the registration. Therefore, whether it is exported to Canada or not, this Canadian certificate with high gold content deserves your attention.
Health Canada updated the list of medical device shortage notices
Health Canada has updated the list of medical device shortage notices on February 7, 2023 https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/shortages/mandatory-reporting.html- To increase the number of medical devices that require mandatory reporting by manufacturers and importers.
For more information about medical device shortage report, please refer to:
Web page of medical equipment shortage:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medicaldevices/shortages.html
Reporting Guide for Shortage and Use Interruption of Medical Devices (GUI-0137):
https://www.canada.ca/en/health-canada/services/drugs-health-products/medicaldevices/shortages/guide-reporting-shortages-discontinuations.html
Report the shortage and production suspension of other medical devices
The Ministry of Health of Canada also encourages manufacturers and importers to report the shortage and shutdown of medical instruments that are not included in the List of Medical Instruments – Shortage Notice.
Health Canada encourages voluntary reporting under the following circumstances:
1. This shortage may cause patient or user safety problems in Canada
2. There is no ready-made substitute device, component, accessory or component
3. The shortage is nationwide
4. Production suspension is likely to lead to supply shortage
Declaration form
Report shortage (including voluntary shortage report), and fill in the electronic shortage report form
https://www.canada.ca/en/health-canada/services/drugs-health-products/medicaldevices/shortages/reporting.html 。
To report the shutdown that will lead to shortage (including voluntary shutdown report), it is necessary to fill in the electronic shutdown report form:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medicaldevices/shortages/report-discontinuation.html 。
Despite the global pandemic, masks are not mandatory. However, you still need to wear Lanhine mask every day to protect yourself.
Post time: Feb-17-2023