• 2026-06-26 05:40:00

South Korea has introduced amendments to both the Medical Device Act and the Regulation on Medical Device Approval, Notification, and Review, bringing important updates for manufacturers and importers. Key changes include expanded use of real-world evidence (RWE), simplified documentation requirements, a broader transition period for approved changes, and the establishment of a formal quality management system (QMS) conformity recognition framework. The amendments reflect South Korea's ongoing efforts to enhance regulatory efficiency, strengthen oversight, and support innovation in the medical device sector.

• 2025-11-21 08:14:15

The Malaysian Medical Device Authority (MDA) has issued the Medical Device (Amendment) Regulations 2025 [P.U.(A) 330], which were gazetted on 11 September 2025. This amendment revises the fee structure for registrations of Class A medical device effective on or after 1 January 2026. Stakeholders are advised to review the changes and plan their submissions accordingly to ensure timely compliance.

• 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 10:37:19

The Thai FDA updated its change notification guidelines, effective 15 January 2025, focusing on model additions/removals and importer/manufacturer info updates for both IVD and non-IVD devices. The update allows modifications to groupings when adding or removing products within the same application. Additionally, adding models is now classified as a Major Change, requiring an extensive documentation.

• 2023-10-20 06:31:20

Recently, TFDA has announced an amendment to the classifications of medical devices. The scopes and identifications of several medical device classifications have been updated to provide more specific and clearer instructions. Among these, the risk level of 3 classifications has been re-determined and there are 11 new additional classifications.

• 2023-08-23 06:09:04

Due to Regulation (EU) 2023/607, the transition period is extended. Some timelines of the related factsheet or guidance are modified accordingly.

• 2023-01-19 05:49:15

It is announced that the MDA amended the terms of the establishment license granted under section 15 of Act 737 in accordance with Act 20's provisions. At least 90 days before the license expires, the establishments must submit an application to the Authority for a renewal.

• 2022-12-27 07:40:22

Indonesia Halal Assurance Agency have issued Decree of Head of BPJPH Regulation Number 133 of 2022 concerning Procedures for Requesting Data Amendment on Halal Certificates. This regulation outlines the types of amendment allowed and the procedures for amendment application in Halal certificates.

• 2022-12-27 03:31:34

An official letter number 6698/BYT-TB-CT was released on November 21, 2022, by the Vietnam Ministry of Health, collecting comments for a draft decree amendment of decree 98/2021/ND-CP

• 2022-02-18 09:44:59

On 9 December 2021, the Vietnamese government issued Decree No. 111/2021/ND-CP amending and supplementing a number of articles of Decree No. 43/2017/ND-CP on Goods Labels, including medical devices ("Decree 111"), which will take effect as of 15 February 2022.