Soutth Korea - Proposed Amendments to the “Enforcement Rule of the In Vitro Diagnostic Medical Devices Act”

The Ministry of Food and Drug Safety (MFDS) intends to amend the "Enforcement Rule of the In Vitro Diagnostic Medical Devices Act" to include the following:

A. Establishment of a legal basis for exemption from redundant submission of qualification proof documents for “in vitro diagnostic medical device quality managers” 

​B. Class I in vitro diagnostic medical devices are subject only to notification

C. The “Period After Opening (PAO)” is indicated on the container or outer package of the “IVD strip for glucose self-test”

D. Establishment of fees for newly developed in vitro diagnostic medical device approval "