• 2026-09-21 03:51:16

Singapore will progressively consolidate healthcare regulatory functions under the Health Sciences Authority (HSA), with functions currently performed by the Ministry of Health's (MOH) Health Regulation Group and subsequently the Secretariat of healthcare Professional Boards to be transferred to HSA. The transition will take place in two phases by the end of 2026 and 2027, respectively, as part of Singapore's move towards a more integrated healthcare regulatory system.

• 2025-01-22 03:13:13

On January 1st, 2025, the Vietnam Ministry of Health issued Decree No. 04/2025/NĐ-CP, extending the validity of import licenses for medical devices until June 30, 2025. This decree updates Clause 2, 3, and 4 of Article 76 in Decree No. 98/2021/ND-CP, as amended by Decree No. 07/2023/ND-CP. These changes aim to allow businesses to continue operations without interruption and ensure smooth operations in medical device management.

• 2024-12-16 03:51:16

The Ministry of Health promulgated Circular 19/2024/TT-BYT dated October 1st,2024, which issued the list of exported and imported medical devices that have been assigned Harmonized System commodity codes according to the Vietnam Export and Import Goods Classification List.

• 2022-07-26 11:10:17

The National Public Procurement Agency, which is responsible for managing the government e-Katalog, issued provision No 122/2022 concerning Procedures for Organizing Electronic Catalogues. This changed previous e-Katalog mechanisms includes the MoH Sectoral E-Katalog.

• 2022-05-26 13:40:37

The National Public Procurement Agency, which is responsible for managing the government's “e-Katalog”, issued provision No. 122/2022 concerning the Procedures for Organizing Electronic Catalogues. This changed the previous “e-Katalog” mechanisms including MoH's Sectoral E-Katalog.

• 2022-03-25 10:41:47

Indonesia's MoH has announced the integration of their licensing system: REGALKES with OSS RBA (Online Single Submission Risk-Based Approach) for new applications of marketing permit and their plans on integrating more licensing services with OSS RBA.

• 2022-03-25 10:38:56

Starting from February 2022, the Indonesia Ministry of Health is accepting product listing of medical devices and other health equipment for their sectoral e-catalogue for health facilities.

• 2022-02-18 08:22:55

Indonesia MoH has officially implemented a notification scheme for certain class A medical devices in the REGALKES system since 10th January 2022.

• 2021-11-24 03:09:42

MOH has recently released new Decree that is intended to unify all regulations on Medical Device Management and implemented from next year.

• 2021-08-26 12:58:20

In July, MOH released two Official Dispatches as guidance on registration routes and document preparation to import SARS-CoV-2 IVD medical devices and biologicals, especially SASR-CoV-2 Antigen Rapid Test Kit (RTK).