The Health Sciences Authority (HSA) Singapore has published the latest guidance document on medical device product registration in January 2022.
Under the evaluation routes for the registration of medical devices in
Regulatory News
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 in November 2021.
One of the most important points to note
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 2021.
For patient-matched medical devices, manufacturers and suppliers are exempt from
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 detailed explanation on the general and specific requirements for standards
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 the classification of certain challenging products.
Medical device (MD) is defined
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 vitro diagnostic medical devices (IVDs) in November 2021.
The main update
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 in August 2021. However, the information was only made available
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 in the Philippines, in November 2021.
The introduction of this advisory is
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 Vitro Diagnostic (IVD) medical devices using the ASEAN CSDT, in August 2021.
The important updates include some additional