IVD Label Change


I am currently tasked with figuring out if the following countries require a notification requirement to their respective competent authority for a label change for a low class IVD: Canada, Hong Kong, USA, and South Korea.

Additionally, do class II Medical Devices need a similar notification update to the respective competent authority for the following countries:
Hong Kong, Costa Rica, India?


Quite Involved in Discussions
You can start with finding out about the change control/change notification procedures for those countries you have listed. In ASEAN, certain label changes are "notifiable only", whilst others might entail "re-registration". It really depends on the content of the change.
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