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
Regulatory News
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
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
Australia TGA Releases Guidance on Exemption for Clinical Decision Support Software
The Therapeutic Goods Administration (TGA) Australia has released a guidance document on Exempt Clinical Decision Support Software (CDSS) for sponsors, manufacturers, suppliers, and software developers in August 2022.
For certain types
Singapore HSA Releases Information on Import and Supply of Unregistered Medical Devices
The Health Sciences Authority (HSA) Singapore has provided some guidance on the import and supply of unregistered medical devices by the request of qualified practitioners in August 2022.
Approval from HSA
Singapore HSA Releases Guidelines on Claims and Claims Substantiation of Health Supplements and Traditional Medicines
The Health Sciences Authority (HSA) Singapore has released guidelines on claims and claims substantiation for Health Supplements (HS) and Traditional Medicines (TM) in July 2022.
For HS, the health claims that
NPRA Malaysia Announces Implementation of Pilot Project for Pharmaceutical Track and Trace for Vaccines
The National Pharmaceutical Regulatory Agency (NPRA) Malaysia has announced their plan to develop a Pharmaceutical Track & Trace system that will cover the entire supply chain, in July 2022.
The system