Indonesia: Draft of Government Regulations concerning the Implementation of Law No. 17 of 2023 concerning Health in Indonesia December 14, 2023
Philippines: PFDA Issued a Draft Guidance Documents on CMDN Initial Application via FDA eServices Portal System December 14, 2023
Singapore: HSA Shares Revisions on Change Notification Guidelines Following EU MDR and IVDR Changes December 13, 2023
Malaysia: Exploring Registration Options: MDA’s Guidelines for IVD Analyzer Registration November 21, 2023
Malaysia: MDA’s Medical Device Advertisement Application Transitions to Paperless Starting December 2023 November 15, 2023
Malaysia: MDA Announces Harmonized QMS Standards for Medical Device Registration in 2024 November 15, 2023
Malaysia: Implementation of the use of Electronic Medical Device Registration Certificate in Malaysia November 8, 2023
Malaysia: The MDA To Cease The Issuance Of Certificate Of Free Sale (CFS) For Export Only Medical Device November 8, 2023
Singapore: Public Comments on Revised Draft of GN-20: Guidance on Clinical Evaluation November 8, 2023
Thailand: Guideline for Submission of Application to Import Under Special Access Under Section 27 in Thailand November 8, 2023
Indonesia: Procedure on Substitution of Imported Medicines and Medical Devices with Domestic Medicines and Medical Devices in the Sectoral e-Catalogue of the Ministry of Health of Indonesia November 3, 2023
Vietnam: New Process for the Registration Application of Class C and D Medical Devices November 1, 2023
Philippines: Food and Drug Administration released the draft Schedule of Fees and Charges for Licensing, Registration and Other Authorizations and Regulatory Services November 1, 2023
