Hi A,
I remember having that conversation a few years ago. If we are talking about medical devices, there are several scenarios.
- A few countries require that the medical device is cleared/approved in the country of origin to be registered there (sorry, I cannot remember which one). When this happened, I recall that we provided evidence that the device was approved in another country (at that time it was CE marked, but it didnt have 510(k) clearance, and it was a US manufactured device). That was accepted by the HA. Another option we were discussing at the time was to justify why. Maybe it's a business case reason (it doesnt make sense to market that device in the country of origin), or a regulatory reason (the device was clasified in such a way in the country of origin that a registration was not necesary). If you provide additional documentation that even though your device is not approved, but for example the facilities where the device is manufactured are ISO 13485 certified, it helps. Most HA are somewhat reasonable with the administrative requirements,so try to get a good relationship with your distributor/consultant in that country so they can communicate with the HA to arrive to a reasonable solution.
- For some countries, having specific clearances/approvals from certain countries gives you an advantage (CE, FDA, ANVISA), in the sense of expedite pathways for registration. I can think of Mexico, Singapore, Australia, Saudi Arabia, Israel. And several countries do not have a specific pathway for FDA/CE marked devices, but usually if you have it, you get a lot less questions about your submission.
- Other countries do not request prior registration of the device in another country, but they may still ask for the history of marketing approvals, PMS data, etc. For these countries, usually you need to focus on the true safety and effectiveness of your device, because they will not rely on other approvals.
Finally, a reminder that every country it's a different regulatory world. Even if you have FDA/CE Mark, it doesnt mean you will not have to do anything else in order to register in other countries. Brazil, Canada, China are clear examples that may require additional testing (as compared to what was required for your FDA/CE Mark submissions).
And at least in the US and EU, there is no requirement of prior approval in the country of origin.
I hope this helps,
Daniela
------------------------------
Daniela Mahan Soler Esq, RAC
Quality and Regulatory Affairs Manager
Munich
Germany
------------------------------
Original Message:
Sent: 18-Jul-2023 18:26
From: Anonymous Member
Subject: No registration/approval in the country of origin
This message was posted by a user wishing to remain anonymous
If a product is manufactured in Country X but not approved/registered in Country X, what obstacles would be faced in getting registered/approved in other countries? For example, are there certain countries where the product MUST be approved in the country of origin? If a CPP is not available, are there other alternatives available?<o:p></o:p>
Any theoretical or anecdotal feedback is welcome - thanks!