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South Korea’s Ministry of Food and Drug Safety (MFDS) passed the Digital Medical Products Act (DMPA) on January 23, 2024, which represents a significant step forward in the regulation of digital health technology. Most provisions of the act will come into effect one (01) year after its publication.
The DMPA is intended to protect the safety and efficacy of digital medical products, including digital convergence drugs, medical equipment, and health support devices. It establishes a comprehensive framework for managing, manufacturing, and importing these products.
This legislation is crucial for digital health regulation and will significantly benefit the digital health field in South Korea. It also addresses key aspects of digital health in South Korea, ensuring a robust and secure environment for digital health innovations.
Key Provisions of the DMPA
- Licensing and Approval: Manufacturers and importers must obtain permits and clearance from the MFDS. The approval procedure includes assessments of potential risks to human health, as well as requirements for continuous monitoring and control of product defects and vulnerabilities.
- Quality Control and Monitoring: The statute requires the MFDS to establish quality control standards for digital medical device software. Manufacturers must demonstrate compliance with these standards, which include regular inspections and the ability to extend the validity of compliance decisions, depending on inspection results. This, in turn, ensures a high degree of quality and safety in digital medical products placed on the market.
- Performance Certification: The MFDS provides performance certification of manufactured or imported digital medical and health support devices. This certification can be utilized for marketing as well as increasing the visibility and reputation of the items.
- Annual and Triennial Plans: Every three (03) years, the MFDS must develop comprehensive safety management plans for digital medical products, including annual implementation plans.
Overall, the DMPA seeks to foster innovation while upholding high safety and quality standards in the expanding field of digital health technologies in South Korea.
With our skilled Regulatory services, you can ensure that your digital medical products meet South Korea’s strict criteria for Regulatory submissions, follow the steps of the approval process, and achieve overall compliance. Streamline approvals for your digital health services and solutions and mitigate risks. Contact us today!
