Hi Karen,
I feel that there are other countries having similar licensing or "registration' requirements for systems, groups, etc. In my opinion some of the countries do not clearly define or explain the different types of device groups as well as in Canada. However, I haven't worked with Canadian licenses in a while; I use to submit applications for Canadian licenses frequently. Here's the link I found for Canadian definitions, to refresh my memory:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-complete-application-new-medical-device-licence.html 1) In the EU, under both the MDD and MDR (Medical Devices Regulation) there is a definition for a "procedure pack" (i.e. meaning "combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;") and a "system" (i.e. "combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose").
2) In the US, I don't feel the FDA defines these different groups as well as Canada; someone correct me if they feel differently and there are clear definitions. From my past orthopedic experience, a "system" could be implants and instruments sold in a surgical tray and used for one procedure--.eg. fracture repair.
I hope this helps.
Kind regards,
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Alyssa Thomas RAC
Principal Consultant
Beaverton OR
United States
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Original Message:
Sent: 23-Oct-2020 14:10
From: Karen Zhou
Subject: Licensing Types
Hello,
I'm currently working on Canadian licensing of medical devices. I was just wondering if anyone here knows any other countries that have a similar licensing system to Health Canada. For example, Canada has a licensing type known as "system" with multiple products and components that can be licensed under one manufacturer. Also, HC has licensing types known as device family, device group as well as device group family. Does anyone here know any other jurisdiction with similar licensing types? Thank you.
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Karen Zhou
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