Sarah Baik- South Korea

“While Class III, and IV medical devices are already required to submit monthly reports, reporting requirements for Class II devices take effect on July 1, 2022 and July 1, 2023 for Class I.”

Sarah Baik

 Asia Actual, Korea

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Korea’s MFDS Implements Monthly Reporting Requirements for Medical Devices

Published on: July 1, 2022

The Korean MFDS now requires all Class II, III, and IV medical devices submit monthly installation reports via an online portal. Class IV devices have been meeting this requirements since 2020 and in accordance with the implementation schedule, Class II medical devices must now comply beginning July 1, 2022. Class I medical devices will then need to comply by July 1, 2023. 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.”

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).

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.

NOTE: Outside parties may have access to this data monthly to provide information about the manufacturing, importation, and distribution of medical devices within Korea. More information to come.

To learn more about the registration process in Korea, please see our page on the topic here and the MFDS’ overview here.

Come Grow With Us

Please contact us if you’d like support understanding these new requirements or are interested in registering your product in Korea. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.

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