Malaysia: MDA Announced The Implementation Of Electronic Establishment License Certificates Starting June 5, 2024 June 10, 2024
Malaysia: Revocation Of Medical Device Authority (MDA) Circular No. 1/2022: Exemption Of The Compliance Assessment Process By Conformity Assessment Bodies (CAB) For The Registration Of COVID-19 Test Kits June 10, 2024
Malaysia: MDA Announced the Implementation of the One License Per Establishment Role Policy Starting July 1, 2024 June 10, 2024
Malaysia: Draft on Guidance Documents: Change Notification For Registered Medical Device – Fifth Edition June 4, 2024
Indonesia: Ministry of Health Letter of Filling New System of Pharmacy and Medical Device Dictionary (KFA: Kamus Farmasi dan Alat Kesehatan) June 4, 2024
Thailand: FDA Announced a Comprehensive Guide to Evaluating Academic Documents and Medical Device Licensing Inspections June 4, 2024
Thailand: Draft Announcement on The Highest Rates of Expenses for Document Evaluation, Analysis, Business Establishment Inspection, or Medical Device Inspection for Monitoring, Auditing, or Surveillance to Control the Manufacturing, Import, and Sale of Medical Devices June 3, 2024
Thailand: Draft Announcement on the Expenses for Document Evaluation, Analysis, Establishment Inspection, or Medical Device Inspection for Monitoring, Auditing, or Surveillance to Control the Manufacturing, Import, and Sale of Medical Devices May 29, 2024
Malaysia: Draft For Public Comment on Guidance Documents: Change Notification For Registered Medical Device – Fifth Edition May 28, 2024
Vietnam: Issuance of New Circular Governing the List of Products Eligible for Price Negotiation and Its Processes by Vietnam’s Ministry of Health May 22, 2024
Malaysia: Encouragement to Submit Medical Device Re-Registration Applications One Year before the Certificate Expiration Date May 21, 2024
Singapore: HSA’s Registration Approvals Recognised by Hong Kong MDD for Class II / III / IV Listing in Hong Kong May 14, 2024
Indonesia: Guidelines for the Circulation of Medical Devices and Household Health Supplies (PKRT: Perbekalan Kesehatan Rumah Tangga) through Electronic Systems May 13, 2024
Indonesia: Implementation of GDPMD Certificate (CDAKB: Cara Distribusi Alat Kesehatan yang Baik) as a Requirement for Marketing Authorization May 9, 2024
Malaysia: Medical Device Authority (MDA) Released Circular Letter No. 1/2024: Medical Devices Imported from or Exported to Countries with No Diplomatic Relations with Malaysia Subject to Trade Restrictions May 8, 2024
