In Korea, the Ministry of Food and Drug Safety (MFDS) regulates the introduction of medical devices into the market. To introduce a medical device in Korea, a local representative, known as a "License Holder," is required to submit the necessary documentation and obtain the appropriate licenses and certifications from the MFDS.

The License Holder is responsible for ensuring that the medical device complies with all regulatory requirements and standards in Korea. They act as the local representative of the manufacturer and are responsible for handling any regulatory issues related to the device.

The License Holder must have a valid license issued by the MFDS and must meet certain criteria, including having a physical office in Korea and a designated person in charge of regulatory affairs.

The License Holder service is usually provided by regulatory affairs consulting firms with expertise in the Korean medical device market. These firms can assist foreign manufacturers in navigating the regulatory requirements and finding a qualified License Holder for their medical device.

It is important to note that the License Holder is not responsible for the safety and efficacy of the medical device itself. The manufacturer remains responsible for ensuring the safety and efficacy of their product and must provide adequate documentation and evidence to support their claims.

We are providing Lincense Holder service to place on Korea medical device market.

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