Singapore HSA Publishes Revised Guidance on Medical Device Product Registration
The Health Sciences Authority (HSA) Singapore has published the latest guidance document on medical device product registration in January 2022. …
Australia TGA Releases Frequently Asked Questions on Reclassification of Medical Devices
The Therapeutic Goods Administration (TGA) Australia has published a set of frequently asked questions (FAQs) on reclassification of medical devices …
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 …
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 …
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 …
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 …