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
Regulatory News
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
read more...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 October 2021.
The information presented is applicable to medical devices and Class
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 2021. The guideline is called “Artificial Intelligence in Healthcare Guidelines (AIHGle)”.
The AIHGle is pronounced
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, in October 2021.
The updates that have been implemented are regarding the
read more...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 act as a reference and will assist manufacturers of active medical devices,