On May 12, 2023, the Ministry of Food and Drug Safety (MFDS) of South Korea issued a notice to make some revisions to the ,Medical EquipmentManufacturing and Quality Control Standards to make it more in line with international standards.The main contents of the revisions include:

For products that combine pharmaceuticals and medical devices, if their main function belongs to medical devices, such products will be clearly defined as review objects.

Considering factors such as the danger of medical devices and the manufacturing process, the previous 26 medical device product categories have been expanded to 64.

The joint review by the provincial food and drug supervision and administration bureau and the quality control review agency has been changed to a single review by the quality control review agency.

Rationalize the application materials for document review.

It is stipulated that if there is no omission in the documents submitted for the conformity assessment review, the submission should be confirmed within 5 days.

This revision is very important for enterprises exporting medical devices to South Korea, as it may affect their production processes and export strategies. To avoid unnecessary trade losses, these enterprises need to pay timely attention to the dynamic updates of this standard and adjust their production processes and export strategies in a timely manner.