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Hello everyone,

I have a question, I can't find a clear answer to but "heard" there are ways to do this, I am just not clear on the how.

A Canadian distributor is seeking to expand their portfolio to Class II medical devices from an non-MDSAP certified OEM based in Europe.
The European OEM is ISO 13485 certified but not interested in applying for MDSAP (sounds familiar?)

Could the distributor, obtain an MDSAP certification, use that for an MDL to sell the OEM's devices in Canada?

If yes, what would be the scope of their MDSAP certification, since the specifications, design and manufacturing are all done by the OEM.

Your guidance is much appreciated.

Thank you,
Hasnaa

Hello Hasnaa,

Yes, as Shirley mentioned, it is indeed possible for a Canadian importer to obtain ISO 13485 and MDSAP certification and act as the Manufacturer of Record. I've gone through this process in the past. However, implementing a Quality Management System compliant with ISO 13485:2016 requires substantial time and effort, and MDSAP audits often come with extended timelines. Additionally, if patents and trademarks are involved, it requires additional work on licensing agreements.

Given the option of MDSAP-certified importers in Canada who specialize in navigating this pathway, I've sometimes recommended to partnering with an existing MDSAP-certified importer to expedite the process, specially for small businesses it has been more beneficial. However it should be determined after thoroughly evaluating the market potential of their product and align it with their broader business strategy.

Regards,

Rutvik Patel

Executive Director, 

Quolis global Inc.

Thank you @Shirley Furesz and Rutvik Patel for your precious guidance. It is much appreciated. 

Hope you are having a good start to your week.

Best,

Hasnaa

Hello Hasnaa,

Yes, as Shirley mentioned, it is indeed possible for a Canadian importer to obtain ISO 13485 and MDSAP certification and act as the Manufacturer of Record. I've gone through this process in the past. However, implementing a Quality Management System compliant with ISO 13485:2016 requires substantial time and effort, and MDSAP audits often come with extended timelines. Additionally, if patents and trademarks are involved, it requires additional work on licensing agreements.

Given the option of MDSAP-certified importers in Canada who specialize in navigating this pathway, I've sometimes recommended to partnering with an existing MDSAP-certified importer to expedite the process, specially for small businesses it has been more beneficial. However it should be determined after thoroughly evaluating the market potential of their product and align it with their broader business strategy.

Regards,

Rutvik Patel

Executive Director, 

Quolis global Inc.

Dear Hasnaa,

I read the suggestions from Shirley and Rutvik and it got me thinking about the challenges I faced in the past. In order to obtain a medical device licence, the actual legal manufacturer needs to apply and needs their QMS MDSAP certified. If an importer acts as the MDSAP-certified importer, the MDSAP holder will have to OWN the trademark and, as Shirley correctly stated, the product label sent in support of the medical device licence application will need to show them as the Legal Manufacturer. In this phase 1, if the OEM wants to be on the label, they could be on the label as the physical manufacturer. 

Phase 2: Once the "distributor" and owner of the trademark in Canada receives the medical device licence approval, I like the idea of the OEM applying for a Private Label Licence (based on the original medical device licence owned by the MDSAP-certified importer and Trademark owner) That new label can then only show the OEM name (a Private Labelled products is allowed to show only the Private Labelled company name without the original medical device licence owner - "distributor" name. Sounds confusing but could possibly work! Several contractual agreements would need to exist and every step is crucial in this scenario...

Good luck! Let me know if you want to chat live about it!

Thank you @Shirley Furesz and Rutvik Patel for your precious guidance. It is much appreciated. 

Hope you are having a good start to your week.

Best,

Hasnaa

Hello Hasnaa,

Yes, as Shirley mentioned, it is indeed possible for a Canadian importer to obtain ISO 13485 and MDSAP certification and act as the Manufacturer of Record. I've gone through this process in the past. However, implementing a Quality Management System compliant with ISO 13485:2016 requires substantial time and effort, and MDSAP audits often come with extended timelines. Additionally, if patents and trademarks are involved, it requires additional work on licensing agreements.

Given the option of MDSAP-certified importers in Canada who specialize in navigating this pathway, I've sometimes recommended to partnering with an existing MDSAP-certified importer to expedite the process, specially for small businesses it has been more beneficial. However it should be determined after thoroughly evaluating the market potential of their product and align it with their broader business strategy.

Regards,

Rutvik Patel

Executive Director, 

Quolis global Inc.