On February 10, 2025, the Ministry of Food and Drug Safety (MFDS) of Korea announced a partial amendment to the “Regulation on Medical Device Groups and Class by Group”. The amendment introduces new subgroups for items that were previously managed under broader groups or require clear classification systems for safety management. The aim is to improve the efficiency of medical device safety management by addressing issues discovered in the current classification system during the approval, review, and complaint handling processes.
The main amendments to the regulation are as follows:
A. Introduction of New Medical Device Groups (Annex 1)
- ‘A04080.02 Sterilizer, ozone
- ‘C21040.02 Dental surgical guide fixation screw, nonimplantable
B. Change in Medical Device Classification (Annex 1)
- One subgroup, ‘A79110.02 Electronic infusion controller for gravity flow infusion systems’, has been reclassified from Class 3 to Class 2.
C. Changes to Medical Device Names (including English name) and Definitions (including corrections) (Annex 1)
- Thirteen subgroups, including ‘A18020.04 Lithotriptor, internal, electrohydraulic’, have had their names definitions amended.
The amendment has been in effect since February 10, 2025. It applies to applications for medical device manufacturing(import) approvals, certifications or changes in approvals, certifications for changes, medical device manufacturing(import) Notification, and requests for technical document reviews submitted from this implementation date onward.
In accordance with the previous regulations, containers, external packaging, and accompanying documents that include the required information can continue to be used for manufacturing and importing until one year from the implementation date.
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