HSA updates GUIDELINES FOR LABELLING STANDARDS OF HEALTH SUPPLEMENTS AND TRADITIONAL MEDICINES including clarification on labelling requirements on the name and address of local dealers for products manufactured in Singapore
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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 Certifications for medical device dealers (including manufacturer, importer and wholesaler).
Accordingly,
read more...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
read more...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
read more...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
read more...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.
Previous related article can be found at the
read more...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
read more...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
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