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
Regulatory News
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
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,
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 different activities, in September 2021. This is in accordance with MDA Meeting
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 registration submission for general medical devices using the ASEAN CSDT, in
NPRA Malaysia and MDA Malaysia Issues Updated Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products
National Pharmaceutical Regulatory Agency (NPRA) Malaysia and Medical Device Authority (MDA) Malaysia have issued an updated guideline, which is the 4th edition, for the registration of drug-medical device and medical device-drug combination
Australia TGA Publishes Guidance Document on Reclassification of Medical Devices in Direct Contact with the Heart, Central Circulatory and Central Nervous Systems
Therapeutic Goods Administration (TGA) Australia has published a guidance document on the reclassification of medical devices in direct contact with the heart, central circulatory system (CCS) and central nervous system (CNS) in August 2021.
The guidance document aims to assist sponsors of medical devices intended to
Australia TGA Publishes Updated Guidance Document on Medical Device Patient Information Leaflets and Implant Cards
Therapeutic Goods Administration (TGA) Australia has published an updated guidance document on medical device patient information leaflets (PIL) and implants cards (including acceptance of Implementation Plans) in October 2021.
The main update is the inclusion of a section about patient information