Malaysia: MDA Released the Second Edition Guidance Document MDA/GD/0005: General Medical Device-Grouping March 13, 2024
Philippines: FDA Released Draft Regulation on the Guideline Prescribing the Rules, Requirements and Procedures in the Application for LTO of Covered Health Product Establishments March 7, 2024
Malaysia: Draft Guidance Document: Placement of HIV Self-Test (HIVST) Kit in Malaysia Market March 4, 2024
Philippines: PFDA Released Draft Regulation on Extension of Regulatory Flexibility for Non-Registrable Class B, C and D Medical Devices February 20, 2024
Vietnam: Amendment and Supplementation of Several Articles of Decree 96/2023/NĐ-CP Regarding Medical Device Management February 20, 2024
Malaysia: MDA Releases Guidance Document MDA/GD/0067: Enhancing Post Market Information Exchange for ASEAN Member States February 20, 2024
Malaysia: MDA Released Guidance Document MDA/GD/0066: Importation of Medical Device for Personal Use February 20, 2024
Thailand: Draft Guidance on the Temporary Storage of Medical Devices Outside Its Specified Location in the Certificate or License February 5, 2024
Thailand: Draft Announcement for the Production or Sale of Medical Devices Exempted under Section 27 (2) (3) and (4) February 1, 2024
Thailand: Draft Announcement on Prohibition of Direct Selling or Direct Marketing of Certain Medical Devices in Thailand January 31, 2024
Thailand: Draft Announcement on Notification of Possession, Movement, Inspection of Readiness, and Costs of Medical Devices that Require Technology Assessment January 31, 2024
Vietnam: Inspection And Review Of The Declaration Of The Applicable Standard Procedure In Vietnam January 29, 2024
