Our translation of the Korean GMP Revision 2 in English is ready.
The document was validated and is now ready for review.
The main modifications are summarized below:
- Removed GMP inspection for class 1, but tightened for class 2, in the past, for class 2 only document inspection required, but since Jan 2014 it has been changed to site inspection by 3rd party
- Language for document submission, both original and Korean languages are required
- Importer should apply for KGMP inspection at least 60 days in advance before the desired date of inspection
- Data from the evaluation reports by other certification body (Summary is not accepted)
- Notice for additional cost charged in case of natural disaster such as earthquake, flood…
If you wish to sell in South Korea you can contact us for a preliminary discussion. See also our services for the registration of medical devices in South Korea here.