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Dear all,
Does someone has experience or knowledge about the following?:
Can a registration of medical devices/in vitro diagnostic device in South Korea be based on the EU CE-mark?
If the South Korean MD/IVD registration can be based on the EU CE-mark:
- What happens with the validity of this registration in case the legal manufacturer is loosing the (EU) compliance (and the CE-mark) for a few months? I would assume that the Korean registration will be invalid as consequence, correct?
- In case the legal manufacturer is able to get EU-compliance again, what would be the consequence for the South Korean registration? The new EU-DoCs just need to be provided to South Korean health authority or would this end up in a new required registration in South Korea?
Thank you very much and have a great weekend!