In January 2025, South Korea's Digital Medical Products Act (DMPA) will come into effect, introducing a comprehensive regulatory framework for digital medical products. This legislation aims to ensure the safety and effectiveness of these products while promoting innovation within the medical device industry.
To meet the needs of Korean medical device manufacturers, Manifest is proud to announce its platform is now available in Korean. We gratefully acknowledge the substantial contribution of Mr. Gyeong-Yeong Choi(cgy12306) of Korea University to this effort. This commitment to our multi-national customers furthers Manifest’s industry-leading internationalization efforts, and is the fifth language in which the platform is now available (English, Italian, German, and Japanese).
Key Provisions of the DMPA:
- Definition and Classification:
- The DMPA defines "digital medical products include digital medical devices, digital convergence medicines, and digital medical or health support devices. Digital medical devices are specified as those incorporating advanced technologies such as intelligent information technology, robotics, and ICT, used for diagnosing and treating diseases.
- Regulatory Oversight:
- The Ministry of Food and Drug Safety (MFDS) is tasked with classifying and rating digital medical products based on their intended use, functionality, and potential risks to human health. Manufacturers and importers must obtain appropriate licenses and permissions from the MFDS, which vary depending on the product's risk classification.
- Quality Management and Cybersecurity:
- Manufacturers and importers are required to maintain comprehensive records to manage and address product defects. They must also implement measures to protect against cybersecurity threats, including hacking and computer viruses. The MFDS will provide guidelines for establishing robust management systems to mitigate these riskially, SBOMs will be required from device manufacturers.
- Software Quality Control:
- The MFDS will establish quality control standards for digital medical device software. Manufacturers can apply for a conformity assessment, valid for three years, to ensure their software meets these standards. Regular inspections will be conducted to verify ongoing compliance, with the possibility of extending the conformance judgment for an additional three years upon successful inspection.
Implications for Medical Device Manufacturers:
- Regulator Compliance:
- Manufacturers must navigate the new licensing and permission requirements set forth by the DMPA. This involves understanding classification system and ensuring that each product meets the specific criteria established by the MFDS.
- Quality Assurance and Cybersecurity:
- The emphasis on quality management and cybersecurity necessitates that manufacturers invest in robust systems to monitor product performance and protect against digital threats. Compliance with these standards is crucial to maintain market access and uphold product integrity.
- Software Development Standards:
- For products involving software, adherence to the MFDS's quality control standards is essential. Manufacturers should prepare for regular assessments an proactive in maintaining compliance to avoid disruptions in product availability.
- Market Access and Innovation:
- While the DMPA introduces more stringent regulations, it also provides a structured pathway for bringing innovative digital medical products to market. Manufacturers that align their development processes with the DMPA's requirements can benefit from increased consumer trust and a clearer route to product approval.
The DMPA represents a significant shift in South Korea's approach to regulating digital medical products. Manufacturers must thoroughly understand and adapt to these new regulations to ensure compliance and capitalize on the opportunities presented by this evolving landscape.
