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 …
MDA Malaysia Publishes Updated Circular on Conformity Assessment Procedures for Medical Device Approved by Recognised Countries
The Malaysian Medical Device Authority (MDA) has published an updated circular regarding the conformity assessment procedures for medical devices approved by recognised countries, …
Australia TGA Publishes Guidance Document on Classification of Active Medical Devices
Therapeutic Goods Administration (TGA) Australia has published the first version of the guidance document on the classification of active medical devices (including software-based medical devices) in October 2021. The guidance document will …
MDA Malaysia Publishes Updates on Establishments Acting as Authorized Representatives and Establishments Carrying Out Different Activities
The Malaysian Medical Device Authority (MDA) has revoked Circular Letter No. 1/2014 that contains two components, namely establishments acting as authorized representatives (AR) and establishments carrying out …
Singapore HSA Publishes Updated Document on Technical Reference for Product Registration Submission for General Medical Devices
The Health Sciences Authority (HSA) Singapore has published an updated document on medical device technical reference, focusing on the contents of a product …