6 days agoPhilippines: Regulatory Flexibility Extension for the Unlisted Class B, C, and D Medical Devices in the Registrable Medical Devices ListThe Philippines FDA (PFDA) extended the Regulatory Flexibility period further through the issuance of FDA Circular No. 2024-003 on 26...
Apr 16Malaysia: Directive Overview of Natural Product Registration Based on 'Guideline on Natural Products with Modern Claim' (w.e.f 4 April 2024)The Drug Control Authorities (PBKD) agreed to register natural products based on the Guideline on Natural Products with Modern Claim,...
Apr 9Australia: Proposed Revision of Manufacturing Principles for Medicines, Active Pharmaceutical Ingredients, and Sunscreens (w.e.f 3 June 2024)Australia will be commencing the PIC/S Guide to GMP – 1 February 2022, PE009-16, starting on 3 June 2024, as the manufacturing principles...
Apr 8Singapore: MOH ACE Implant Subsidy List (ISL) and HTA Process Updates The Ministry of Health (MOH) of Singapore implementing the Implant Subsidy List effectively from 1 December 2023. The list consists of...
Apr 3Hong Kong: MDACS Accepts Marketing Approval from Health Sciences Authority (HSA) of Singapore (w.e.f. 2 April 2024)The Health Sciences Authority (HSA) of Singapore was added to the Medical Device Division (MDD) acceptance list for marketing approval...
Apr 2India: PSUR Online Submission for Medical Devices/In-Vitro Devices Marketing Authorization (w.e.f 01 April 2024)The Circular, PSUR-13011(15)/1/2024-eoffice, was circulated by the Central Drugs Standard Control Organization (CDSCO) regarding the...
Mar 27Singapore: UDI Phase 2 Compliance Date Approaching (w.e.f 1 November 2024)The Health Sciences Authority (HSA) is reminding all stakeholders, manufacturers, registrants, importers, and wholesalers for the...
Mar 26Argentina: ANMAT Reviewing Changes to Sales Conditions for Medicinal Specialties (21 March 2024)Ministry of Health mandated the National Administration of Medicines, Foods, and Medical Technology (ANMAT) through Resolution...
Mar 20Hong Kong: CP-05 for Listed Medical Devices Distributors by MDD (1 March 2024)On March 1, 2024, the Medical Device Division (MDD) released the code of practice (CP-05) specifically for the listed medical device...