South Korea’s Ministry of Food and Drug Safety (MFDS) emitted two regulatory provisions on Medical Devices. These two provisions entered into force in their final version on January, 17 2020 to change the regulatory system for the access to the Korean market.

South Korea: The regulation for Medical Devices importation is changed.

The MFDS No. 2020-4 “Revisions to the Regulations on Exemptions from Import Requirements for Medical Devices” provision extends the types of medical devices that need the pre-market authorization and the production certification, it clarifies the terminology for Medical Devices for research intended use, it adjusts the required documentation to present the custom-made devices exemption application and allows to modify the devices declared use.

The MFDS No. 2020-5 provision, instead, contains the provisions needed to regulate the Medical Devices supply to the country health system in extreme cases of absence or urgency.

These provisions include also the supply application analysis procedures, importation/supplying plan presentation and definition and the storage procedures of the devices themselves.

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