Australia TGA Publishes Updates on Personalised Medical Devices

The Therapeutic Goods Administration (TGA) Australia has published the latest document on personalised medical devices, including 3D-printed devices, in November …

read more...

Australia TGA Publishes Guidance on Standards for Biologicals

he Therapeutic Goods Administration (TGA) Australia has published a new guidance on Therapeutic Goods Orders (TGO) 109 to provide a …

read more...

Singapore HSA Publishes Finalised Medical Devices Product Classification Guide

The Health Sciences Authority (HSA) Singapore published the latest Medical Devices Product Classification Guide in November 2021, to assist with …

read more...

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 …

read more...

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 …

read more...

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 …

read more...

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 …

read more...

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 …

read more...

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.  …

read more...