The Korea Government regulates the Medical Device and Cosmetic Registration process through the MFDS. It was realigned in 2013 where major updates with the Health Ministry took place. MFDS revised Article 49 of the Medical Devices on April 4th, stating that all Medical Devices registered and approved after October 8, 2020 will have its validation only for five years. It will be applicable to all Medical Devices. Renewal by the manufacturer’s is possible only every five years.
Contact Morulaa for Latest Updates in the Medical Device Sector and if you want to register your products in India and South East Asia.
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