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, …
Singapore HSA Revises Guideline on Consignment Importation of Therapeutic Product
Singapore HSA revised Guideline on Import a Therapeutic Product on Consignment Basis. The revised guideline provides further clarity to the …
Malaysia MDA Update on Transition Period for the Use of Electronic Medical Device Registration Certificate
Malaysia MDA released an update on the use of Electronic Medical Device Registration Certificate starting 2 May 2023. Establishment can …
Singapore HSA Updates Guidance on Unregistered Therapeutic Product Import and Supply
In March 2023, HSA updated Guidance on Import and Supply of An Unregistered Therapeutic Product For Patients’ Use. See Pharma …
Malaysia MDA Issued Guideline on Notification of Custom-Made Medical Device
Malaysia MDA issued the first edition guideline on Notification of Custom-Made Medical Device (MDA/GD/0064) on 28 February 2023. This guidance …