Regulatory Open Forum

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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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.

------------------------------
Karen Zhou
------------------------------

Hello Karen,

There are other regulatory registration schemes out there similarly, but Health Canada is as far as I know the only one with those definitions for products, i.e. system, groups, family, etc.  Other regulatory pathways have similar wording or similar definitions like product family or product grouping, but Health Canada has by far the most well defined.  There are also some regulatory agencies that do not have any definition and leave it completely up to the company to define what is a device family or product grouping - which I strongly recommend already for companies to clearly define within their own quality system.  Also as Alyssa mentioned there are other categories like procedure packs, convenience kits, and combination products may or may not be defined by different regulatory region pathways.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 25-Oct-2020 20:15
From: Alyssa Thomas
Subject: Licensing Types

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,

------------------------------
Alyssa Thomas RAC
Principal Consultant
Beaverton OR
United States

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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Hi Karen,

It is possible that Singapore did the same as they integrated portions of the Canadian medical device regulations into their own regulations.

Kind regards,

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Nicole Landreville FRAPS, RAC
Mississauga ON
Canada
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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
------------------------------

This message was posted by a user wishing to remain anonymous

​Hi Karen

India and Singapore follows the same licensing system. India took reference from Singapore regulations to integrate the same in to their regulations.

Thanks!
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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