Which one comes first among: KGMP (Korean Good Manufacturing Practice), product license, TDR (Technical Document Review) ?
This is not a quiz, however often people are puzzled as to which one to apply for first.
So far, the sequence has been like this:
- TDR
- product license
- KGMP
The reason was that you needed the application number for your product license in order to apply for the KGMP.
There is already a shift in the sequence of South Korea medical device registration in such a way that KGMP application is usually done at the same time as the product license application. The reason behind this being the 2 months it takes between the KGMP application and the actual inspection.
In the future we heard from MFDS that the KGMP application could be done before the product license which could obviously accelerate the whole process.
