• 2026-10-26 09:33:44

The Ministry of Food and Drug Safety (MFDS) of South Korea has recently revised regulations concerning medical device adverse event reporting and Korean Good Manufacturing Practice (KGMP) and introduced a new regulation governing the designation and management of organizations involved in medical device quality management.
These regulatory updates aim to clarify adverse event reporting requirements and timelines, while improving regulatory clarity by separating KGMP conformity assessment requirements from provisions governing assessment bodies and training organizations.
This newsletter provides an overview of three regulatory updates that took effect on July 1 and September 22, 2026.

• 2026-02-25 04:14:57

The Ministry of Food and Drug Safety (MFDS) has amended the Regulation on Permission, Notification, Review, Etc. of Medical Devices, effective 26 January 2026. The revision expands acceptable clinical documentation, integrates Class II certification responsibilities, refines the regulatory framework for innovative medical devices, clarifies technical documentation requirements, and strengthens cybersecurity submission obligations for connected devices. These updates aim to enhance regulatory clarity, align with international standards, and improve the efficiency of approval and certification procedures in South Korea.

• 2025-09-24 09:35:21

On September 4, 2025, Qualtech hosted a webinar focusing on the medical device regulatory landscapes of Japan and South Korea. Led by our Japan and South Korea Registration Team Leaders, the session offered participants a structured overview of both markets, covering regulatory frameworks, registration pathways, and key updates shaping compliance today.

• 2025-08-15 01:48:59

On September 4th, join Qualtech for an insightful webinar, "Entering Japan and South Korea: Understanding PMDA and MFDS Requirements for Medical Devices". This session will offer practical guidance on navigating the regulatory systems of Japan and South Korea – ideal for companies seeking to accelerate market entry and avoid compliance-related issues.

• 2024-03-01 08:29:27

Starting from 1 January 2024, Hong Kong Medical Device Division (MDD) has accepted on a regular basis marketing approvals from the Ministry of Food and Drug Safety (MFDS) of South Korea and National Medical Products Administration (NMPA) of Mainland China to support the listing application of medical devices in Hong Kong.

• 2021-08-30 01:11:33

The Medical Device Division (MDD) will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” by providing marketing approval from China's National Medical Products Administration (NMPA) and Korea's Ministry of Food and Drug Safety (MFDS).

• 2020-04-14 01:28:54

醫療器械部將繼續進行試驗，以研究當地負責人（LRP）證明其醫療器械符合“醫療器械安全和性能的基本原則”的可行性。