South-korea Regulatory News

The Ministry of Food and Drug Safety (MFDS) in South Korea consults for the draft amendment of the Regulations on quasi-drug classification numbers on May 9th, 2023. This is to improve the efficiency of quasi-drug product approval (report) by updating the quasi-drug classification numbers.

The main amendments are:

• Assign quasi-drug classification numbers to ‘products used for sanitary treatment of bleeding and lochia (postpartum vaginal discharge) after childbirth’ that are newly designated as quasi-drugs: Quasi-drug classification number 3510, 3520, 3530, and 3600
• Remove the quasi-drug classification number of items converted to biocides, according to the Consumer Chemical Products and Biocides Safety Control Act (K-BPR): Quasi-drug classification number 4300, 4310, 4910, 5100, 5110, 5120, 5200, 5210, and 5220

If you have any opinion on this draft amendment, please write your opinion in the provided format and submit it to MFDS.

The deadline for this consultation is May 29th, 2023.