Singapore HSA included Medical Device Singapore Audit Program (MDSAP) certification as one of the acceptable lists of Medical Device’s QMS Certifications for medical device dealers (including manufacturer, importer and wholesaler).
Accordingly,
Regulatory News
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 Products (TP) Advertisement.
Minor revisions include:
– Redefining the list and terms
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 Devices, based on the various feedback and comments received from
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 unpredictable timeline and issues with regards to the transition to
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 the field of pharmaceuticals and cosmetics.
This Circular is effective on
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 1st August 2022.
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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, the Therapeutic Products Branch (TPB), Health Products Regulation Group of
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 condition for approval and documentary requirement to apply for importation
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 download the Medical Device Registration Certificate from MeDC@St2.0+ system once