Thailand FDA Implements GMP Clearance Temporary Process During COVID-19 Pandemic
The State Drug Regulatory Authorities overseas, responsible for the assessment of manufacturing standards according to GMP principle, have postponed the …
Singapore HSA to Commence Phase 1 Implementation of Unique Device Identification (UDI) System
From 1st November 2022, all medical devices under the closed list of high-risk implantable published in HSA’s guidance document GN-36: …
Vietnam Ministry of Health Updates Guidance Report of Bioavailability/Bioequivalence for Drug Registration
This Circular is issued on 5 Sept 2022, effective on 1 Nov 2022, and replaced the current guideline Circular 08-2010/TT-BYT …
Vietnam Ministry of Health Updates Guideline on Registration of Drug and Medicinal Materials
Circular 08/2022/TT-BYT (Circular stipulating the registration of DRUG, Medicinal materials) was issued on 5th September 2022 and will be implemented …
MDA Malaysia Releases Information on Harmonised Classification of Medical Devices in ASEAN
The Malaysian Medical Device Authority (MDA) has released the first edition of the guidance document on harmonised classification of regulations …
Australia TGA Releases Guidance on Exemption for Certain Clinical Decision Support Software
The Therapeutic Goods Administration (TGA) Australia has released the first version of the guidance document on Exempt Clinical Decision Support …
Singapore HSA Updates Guidance on Therapeutic Product Registration
The Health Sciences Authority (HSA) Singapore has published the updated guidance document on the regulatory processes and requirements for therapeutic …
Australia TGA Updates Regulation of Software Based Medical Device
The Therapeutic Goods Administration (TGA) Australia has released updates on the regulation of software based medical devices in August 2022. …
Singapore HSA Updates Guidelines on Voluntary Electronic Labelling for Complementary Health Products
The Health Sciences Authority (HSA) Singapore has published the updated guidance document on voluntary electronic labelling for complementary health products …