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July 7, 2024
Approximately 5 minutes
South Korea License Maintenance: Monthly Supply Reporting and Amendment Requirements
South Korea Medical Device License Maintenance and Reporting
Maintaining market access in South Korea requires strict adherence to the Ministry of Food and Drug Safety (MFDS) requirements for license amendments and ongoing reporting. Failure to comply can lead to severe consequences, including license revocation and substantial administrative fines.
License Amendment Requirements
Manufacturers must proactively manage and report any changes to the specifics of their approved product license or certification, as mandated by Article 12 Paragraph (1) of the Medical Device Act.
- Mandatory Approval/Certification: Any change, including seemingly administrative ones such as a change in the location of the manufacturer, requires the manufacturer to first obtain approval or certification to file an amended report with the MFDS.
Mandatory Monthly Supply Reporting
The MFDS has established a mandatory system for monitoring the distribution and supply of medical devices across all risk classes (I, II, III, and IV).
- Legal Basis: This requirement is defined by Article 31-2 of the Korea Medical Device Act.
- Submission Details: Manufacturers must submit monthly reports detailing the supply of their medical devices. These reports are submitted through the "integrated medical device information system" using specific forms (e.g., Form 48-2).
- Reporting Deadline: Reports must be submitted by the end of the month following the supply of the medical devices.
- Staggered Implementation: The requirement was phased in by risk class, starting with Class IV devices (July 1, 2020) and eventually including Class I devices (July 1, 2023).
- Exclusions: This monthly reporting requirement does not apply to medical devices primarily used at home, such as Direct to Consumer (DTC) products.
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