On December 17, 2024, the Ministry of Food and Drug Safety (MFDS) of South Korea issued a partial revision of the medical device standard specifications. The revision was made to align with international standards, aiming to enhance the safety and quality levels of medical devices distributed domestically and to prevent potential health risks to the public.
The revisions made to align the medical device standards with international standards are as follows:
- Medical Supplies and Dental Materials: 14. Root canal filler, endodontic, paste, calcium hydroxide/zinc-oxide eugenol, root canal filler, endodontic, sealer (1 type)
- Medical Instruments: 48. Electric Wheelchair, Disability scooter, automated (1 type)
The application of international standards (IEC, ISO) for testing criteria and methods for these two types of products will ensure product performance and safety.
The revision will be implemented six months after the notice is issued.
Please refer to the attached document below.
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