Reclassification and re-categorization of medical devices
The Ministry of Food and Drug Safety (MFDS) is publishing Korea medical device regulations update on a regular basis. It recently published a notice to inform that a reclassification and re-categorization of products would occur.
- Reclassification of 244 products previously known as in vitro radio-pharmaceuticals to medical devices
- guideline was also published to help updating existing licenses
- Change in the categorization of products
- Create new sub-categories for new products
- Clarification in the definition of products
- Class adjustment based on international classification
- Deletion of product categories
For instance regarding the re-categorization of products:
- Sub-category created for: ultrasound gel, breast milk composition analyser (3 more products listed)
- Break down category “drill hand-piece, surgical, electrically-powered” as single use and reusable (17 more products listed)
- Pulse oximeter is classified as medical device and paraffin bath as non-medical device (258 more products listed)
- Endoscopic forceps used for heart and central nervous system reclassified from class 1 to 4
- Cutting dental casts withdrawn from medical device
The details can be found on MFDS website: www.mfds.go.kr
If you wish to sell in South Korea you can contact us for a preliminary discussion. See also our services for the registration of medical devices in South Korea.
