Singapore HSA Updates Medical Device Adverse Event Reporting Form
Singapore’s Health Sciences Authority (HSA) updated the Medical Device Adverse Event Reporting Form for Medical Device Dealers (MDAR1 Form). As …
Singapore HSA Updates Health Supplement & Traditional Medicines Labelling Guideline
HSA updates GUIDELINES FOR LABELLING STANDARDS OF HEALTH SUPPLEMENTS AND TRADITIONAL MEDICINES including clarification on labelling requirements on the name …
Singapore HSA Accepts MDSAP certification for Medical Device’s QMS Certification
Singapore HSA included Medical Device Singapore Audit Program (MDSAP) certification as one of the acceptable lists of Medical Device’s QMS …
Singapore HSA Updates Advertisement Guidance for Therapeutic Products
Singapore’s Health Sciences Authority (HSA) updated EXPLANATORY GUIDANCE TO THE HEALTH PRODUCTS (ADVERTISEMENT OF SPECIFIED HEALTH PRODUCTS) REGULATIONS for Therapeutic …
Singapore HSA Updates Guidance on the Risk Classification of IVD Medical Devices (GN-14)
Singapore’s Health Sciences Authority (HSA) has finalised the updated GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical …
Malaysia MDA Updates on the Approach to Expired EC Certificate for New Registration and Re-registration of Medical Device
MDA has taken an approach to allow expired EC Certificates to be used for conformity assessment procedures due to the …
Vietnam MoH Issues Circular 41/2023/TT-BTC on Payment in Field of Pharmaceuticals and Cosmetics
On June 12, 2023, the Minister of Finance issued Circular 41/2023/TT-BTC on the rate, collection, payment, management and use in …
Singapore HSA Announces Phase 2 of Voluntary Notification of Health Supplements and Traditional Medicines
Singapore Health Sciences Authority (HSA) had implemented the first phase voluntary notification initiative for Health Supplements and Traditional Medicines on …
Singapore HSA Updates Therapeutic Product Registration Guidelines
As part of Singapore HSA’s ongoing initiatives to improve regulatory efficiency and enhance clarity in HSA’s regulatory requirements and processes, …