South Korea License Maintenance

Monthly Reporting Requirements

As outlined in our blog on the topic, the Korean MFDS began requiring manufacturers submit monthly installation reports on July 1, 2020 for Class IV medical devices. Then it was Class III on July 1, 2021 and now Class II medical devices must comply beginning July 1, 2022. Class I medical devices will then need to comply by July 1, 2023.

Under these data requirements, manufacturers will need to submit monthly reports to the Minister of Food and Drug Safety. The reports will be submitted through the “integrated medical device information system” and will include Form 48-2 and other documentations. These reports must be submitted by the end of the month following the supply of the medical devices.

These requirements do not apply to medical devices used at home, such as Direct to Consumer (DTC).

The requirements are defined by “Article 31-2 of Korea Medical Device Act” and Article 54-2 (Reporting on the Details of Supply of Medical Devices) of Reinforcement rule of the Medical Device Act.”

Monthly Reporting Implementation Dates

The monthly importing requirements have gone into effect at different times depending on the classification.

• Class IV medical devices: July 1, 2020
• Class III medical devices: July 1, 2021
• Class II medical devices: July 1, 2022
• Class I medical devices: July 1, 2023

In Korea, medical devices are classified into four categories, I, II, III, and IV based on their risk level. Class I pose little risk, while Class IV are high-risk devices.

Contact Asia Actual with any medical device license amendment questions in South Korea. Our local, bi-lingual regulatory experts are well positioned to assist.