[GMP Update] Intended-Use Differences Between Device Specifications and Licences (December 2023).

MFDS stated that the revised medical device GMP operating guidance consolidated application documents and enabled formal review of the device specification document's intended use, performance, directions and precautions.

MFDS noted that the intended use stated by an overseas manufacturer—including indications, efficacy or purpose—often differs from the use authorised in Korea when an importer seeks device approval.

A Korean licence records the intended use for import and sale in Korea. The device specification document may also include uses claimed for sale in other countries.

The October 2023 GMP operating guidance discourages a simple line-by-line comparison with the licence. A document may be accepted where the licensed intended use falls within the scope of the device specification document.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?searchType=ALL&pageNum=2&&pstSno=10&bbsSno=1339