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...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...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
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
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
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
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
read more...The Health Sciences Authority (HSA) Singapore has released a new guideline to outline the process involved for voluntary notification of Health Supplements (HS) and Traditional Medicines (TM) in July 2022.
Using
Hong Kong Drug Office has published a set of frequently asked questions on Phase 2 requirements of bioavailability (BA) and bioequivalence (BE) studies in July 2022.
There is an addition of
The National Pharmaceutical Regulatory Agency (NPRA) Malaysia has published the second edition of the variation guideline for pharmaceutical products in July 2022.
The latest guideline has been updated in accordance with
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