This guidance applies to the regulatory pathways of clinical trial approval, manufacturing, and import licensing (subject to clinical trial data submission)

MFDS requires the submission of 'Technical Documents' for the certification and approval of medical devices.

Medical device registration licenses do not expire, but the KGMP Certificate must be renewed every three years. License Holder Requirements. A Licensed Local ...

All companies planning to sell a medical or in vitro diagnostic (IVD) device in South Korea must register their product with the Ministry of Food and Drug ...

The purpose of this Act is to promote the efficient management of medical devices and further contribute to the improvement of public health by providing for ...

The primary regulations governing medical devices in South Korea include the Medical Devices Act (MDA) and its associated regulations.

To access the Korean medical device market, the importer based in Korea is to be designated for foreign manufacturers, and has to be: ▪ a business license ...

Manufacturers and suppliers intending to sell or import medical devices in South Korea must first obtain approval from the Ministry of Food and Drugs Safety ( ...

Class II, III, and IV devices: The manufacturer of Class II, III, and IV devices shall obtain pre-market approval which is valid for 5 years. The registration ...