Hello Anon,
These terms can be and often are used interchangeably. Personally I see the term registration is just that - a registration. This means there is a notification, maybe an application, or a license completed. There would only be information stated about the device and maybe very minimal information provided, such as maybe only copy of labelling. As an example an international registration with the US FDA for many Class I devices, these are 510(k) Exempt, so to place the product on the market it is literally just a registration (or medical device listing) on the FDA's database. This registration does not involve any "approval" or maybe there is a small acceptance made by the regulatory agency.
On the other side I personally see the term submission as much more where you are compiling technical documentation or a dossier to submit to an agency for review. This would be an instance where much documentation is gathered about the device specifications, performance, testing, or clinical data and submitted to the agency for review. Following the same example this would be a US FDA 510(k) application which would be a submission of significant technical information related to the device. A submission for me requires a type of "approval" in order to place the product on the market.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 28-Apr-2020 09:55
From: Anonymous Member
Subject: International Registration vs. International Submission
This message was posted by a user wishing to remain anonymous
Hello Everyone,
Please, I would like clarification. Is there a difference between an International Registration and an International Submission? I have worked in companies where the two terms are used interchangeably.