South Korea , October 25, 2025 – South Korea’s Ministry of Food and Drug Safety (MFDS) has announced important regulatory updates that will affect how medical device manufacturers and importers report their production and performance data. Through Public Notice No. 2025-438, issued on October 22, 2025, the MFDS has partially revised the Regulations on Reporting of Medical Device Production, Export, Import, and Repair Performance. This move is part of the country’s preparation for the Digital Medical Products Act, which comes into force on January 24, 2025. The new legislation aims to strengthen oversight of digital health technologies and streamline how manufacturers handle their compliance obligations.
What’s Changing under the Digital Medical Products Act
The revision introduces a clearer framework for digital medical devices, ensuring that reporting procedures reflect their unique technical characteristics.
- Digital Device Inclusion: For the first time, the regulation explicitly defines which digital medical devices fall under the reporting requirement. While standalone software is excluded, other digital medical devices must now be reported using newly developed forms (Forms 10–18).
- Product Code Based Reporting: Reporting will shift to a product code format, improving traceability and efficiency in monitoring devices post-market.
- Updated Employee Reporting: The employee reporting format has been reorganized to align standards across the medical, food, and pharmaceutical industries.
- Data Confidentiality: A new clause introduces strict confidentiality obligations for performance reporting agencies, preventing unauthorized use or disclosure of sensitive data.
The MFDS is also inviting feedback from stakeholders until November 14, 2025, allowing industry representatives and companies to share their views on the proposed changes.
What This Means for Manufacturers
For medical device manufacturers, especially those involved in digital or connected medical technologies, this update signifies the beginning of a new compliance phase in South Korea. Companies will need to reassess their internal documentation, reporting mechanisms, and data protection policies to meet these updated requirements.
Foreign manufacturers exporting to Korea should ensure that their local license holders or importers are ready to handle the revised reporting formats before the new Act takes effect early next year. Beyond compliance, this change underscores South Korea’s growing emphasis on digital health governance, placing it among the more progressive regulators in Asia when it comes to integrating technology and regulation.
How Morulaa Can Help
At Morulaa Healthtech, we see this as a proactive step by the MFDS to align regulatory frameworks with emerging digital medical technologies. As a consulting partner supporting global manufacturers with registration and compliance in Asian markets, we recognize the importance of anticipating these transitions early. Our team continues to assist clients in preparing for Digital Medical Products Act implementation—helping them adapt to new reporting structures, ensure data security, and maintain uninterrupted market access in Korea.