IVD Label Change

[regaffairsuser]

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?

 

[Junn1992]

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.