Singapore: HSA Updated Medical Device Product Registration Guidance Documents and Related Templates August 21, 2023
Vietnam: Vietnam’s Ministry of Health and Ministry of Finance issues New Circular Regulations that benefits Medical Device Industry and Draft Regulation pertaining to exporting and importing MD with HS Code August 16, 2023
Singapore: Fifth Revision of Singapore’s Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices August 14, 2023
Malaysia: MDA Invites for Public Feedback on draft of First Edition Guidance Importation of Medical Device for Personal Use August 14, 2023
Indonesia: Ministry of Communication and Informatics (Kominfo) proposed changes on the standards for Telecommunication Equipment and/or Equipment Short Distance Telecommunications Devices August 8, 2023
Thailand: Thai FDA released a draft Ministry of Public Health Announcement on the Quality System to Produce Medical Devices B.E. August 7, 2023
Thailand: Thai FDA released a draft Ministerial Announcement on the Quality Management System for Importing or Selling Medical Devices, B.E. August 7, 2023
Indonesia: e-Catalogue Opening Submission for Maintenance and Repair Services for Healthcare Facilities August 2, 2023
Philippines: Draft Guidelines for Rules and Regulations for Establishment and Operation of Medical Magnetic Resonance Imaging (MRI) Facilities July 27, 2023
Indonesia: Ministry of Health issued Circular Letter for Medical Devices Post Market Testing July 27, 2023
Transition Period for the Registration of COVID-19 Test Kits with Exemption from Compliance Process by the CAB July 20, 2023
Malaysia: MDA’s Approach to Expired EC Certificates for New Registration and Re-Registration of Medical Devices July 3, 2023
Malaysia: MDA Withdrawn the Guidance Document: MDA/GD/0059 for COVID-19 RTK (SELF – TEST) – REQUIREMENTS June 28, 2023
Singapore: The HSA Recognized By WHO As Stringent Regulatory Authority (SRA) For High-Risk In Vitro Diagnostic Medical Devices (IVDs) June 27, 2023
