Australia TGA Updates Guidelines on Clinical Evidence for Medical Devices
The Therapeutic Goods Administration (TGA) Australia has published an updated guideline on clinical evidence requirements for medical devices, including in …
Hong Kong Drug Office Updates Frequently Asked Questions’ Page
Hong Kong Drug Office has updated and included the latest set of frequently asked questions (FAQs) on their official website …
Philippines FDA Publishes Advisory on Abridged Route for ASEAN-Registered Medical Devices
The Philippines Food and Drug Administration (FDA) has issued Advisory No. 2021-3084, with details regarding the abridged route for the registration of medical devices …
Singapore HSA Publishes Updates on Technical Reference for Submission of In Vitro Diagnostic Medical Devices
The Health Sciences Authority (HSA) Singapore published a latest update on medical device technical reference, discussing about the contents of a product registration submission for In …
Australia TGA Publishes Guidance on Standard for Human Cell or Tissue Products
The Therapeutic Goods Administration (TGA) Australia has published a guidance document for Therapeutic Goods Orders (TGO) 108 for manufacturers and sponsors of biologicals and human cell or …
Australia TGA Releases Update on Reclassification of Certain Medical Devices
The Therapeutic Goods Administration (TGA) Australia has announced an update on another medical device reform, which is the reclassification of certain medical devices, in November 2021. …
Singapore HSA Announces Update on Regulatory Fee Revision for Health Products
The Health Sciences Authority (HSA) Singapore has announced a critical update regarding the revision of the regulatory fee for health products, which was published on the …
Australia TGA Publishes Guidance Document on Global Medical Device Nomenclature (GMDN) Terms
Therapeutic Goods Administration (TGA) Australia has published a guidance document on the Global Medical Device Nomenclature (GMDN) Terms, which discusses about the information to support sponsors and manufacturers, in …
Singapore MOH, HSA, and IHiS Publish Guideline on Artificial Intelligence in Healthcare
The Ministry of Health (MOH), the Health Sciences Authority (HSA), and the Integrated Health Information Systems (IHiS) have co-developed and published a guideline on artificial intelligence (AI) in October …