The State Drug Regulatory Authorities overseas, responsible for the assessment of manufacturing standards according to GMP principle, have postponed the assessment of manufacturers located inside and outside the authority’s country
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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: Guidance on Medical Device UDI System, that are to be
read more...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 dated 26 Apr 2010. Vietnam Ministry of Health stipulates in
read more...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 on 20 Oct 2022, replacing the current guideline Circular 32/2018/TT-BYT
read more...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 involving medical devices in ASEAN countries in August 2022.
Annex A
read more...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 Software (CDSS) in August 2022.
CDSS is used during clinical practice
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 product registration in August 2022.
HSA has updated the details on
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.
The guidance was prepared to assist manufacturers and sponsors with the
read more...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 (CHP) in August 2022.
There are some questions and answers included