• 2025-09-24 08:47:47

The Ministry of Food and Drug Safety (MFDS) has announced amendments to both the Enforcement Rules of the Medical Device Act and the Medical Device Standards. The revisions, implemented between April and August 2025, included higher fees for innovative medical device reviews, exemptions from documentation requirements, stricter administrative sanctions, and the establishment of long-term follow-up requirements. In addition, amendments to the Medical Device Standards have been finalized and are scheduled to take effect in July 2026, introducing new standards and aligning existing ones with international norms.

• 2025-03-25 09:14:44

South Korea's newly enacted Digital Medical Products Act (DMPA) establishes a dedicated regulatory framework for AI-driven devices, digital therapeutics, and health apps, ensuring their safety, effectiveness, and quality. Taking effect in January 2025, the Act introduces risk-based classifications, software and cybersecurity requirements, and clear pathways for digital health product approvals, positioning Korea as a global leader in digital health regulation.

• 2022-08-30 03:32:59

Starting July 1, 2022, MDA fully implemented the Medical Device (Responsibility & Establishment) Regulations.

• 2021-04-26 03:09:33

Medical Device Act, the act that separates medical devices from the genre of medicines under Pharmaceutical Affairs Act, will be fully implemented on May 1st, 2021. Along with Medical Device Act, Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License will come into force on the same date.