Thailand: Notification of the Ministry of Public Health RE: Classification of Notification Medical Device (Class B and Class C) No. 3 B.E. 2565 2022 November 22, 2022
Singapore: GN-33: Guidance on the Application of Singapore Standard Good Distribution Practice for Medical Devices November 13, 2022
Vietnam: Procedures For Receiving, Appraising, Issuing, Post-Inspection, And Withdrawing The Circulation Number Of The Medical Devices October 13, 2022
Philippines: FDA Issued FDA Circular 2022-008: Guidelines For The Abridged Processing Of Application For Registration Of Medical Devices Approved By The National Regulatory Authority Of Any ASEAN Member Country October 11, 2022
Philippines: The Philippines FDA Amended FDA Circular No. 2021-025 Entitled, “Guidelines for Application of Authorizations at the Food and Drug Administration in Light of the Extended State of Public Health Emergency” October 10, 2022
Malaysia: MDA Issued Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027) October 2, 2022
Malaysia: Guideline for Registration of Orthopoxvirus (Monkeypox) IVD Test Kits by MDA September 29, 2022
Philippines: Guidelines on the Use of the Food and Drug Administration e-Services Portal System for License to Operate (LTO) Application of Retailers of Medical Devices September 14, 2022
Philippines: Transfer of Product Registration of Alcohol Swab with 70% Isopropyl Alcohol from Centre for Device Regulation, Radiation, Health, and Research (CDRRHR) to Centre for Drug Regulation Research (CDRR) September 14, 2022
Malaysia: MDA Released Two New Guidance Documents on Harmonized Risk Classification of Medical Devices and Borderline Products in ASEAN September 12, 2022
Singapore: Minor Update To Guidance For Importation Of Unregistered Medical Devices For Exhibition In Singapore September 9, 2022
