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
Regulatory News
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
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 tissue (HCT) products.
The guidance document specifies the requirements or conditions around
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.
The reclassification of certain medical devices came into effect on 25 November 2021. The
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 HSA website in November 2021.
The regulation of health products is managed