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
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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
read more...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
read more...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 To Market insider: https://www.pharmatomarket.com/singapore-hsa-updates-unregistered-therapeutic-product-import-and-supply-guidance-and-forms/?utm_source=rss&utm_medium=rss&utm_campaign=singapore-hsa-updates-unregistered-therapeutic-product-import-and-supply-guidance-and-forms
Minor revision was made by HSA to the
read more...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 document specifies requirements and notification process for the applicant to obtain
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