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,
Regulatory News
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
read more...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
read more...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
read more...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
Singapore HSA Publishes Document on Common Questions for Generic Drug Applications
The Health Sciences Authority (HSA) Singapore has published a document on the common questions received for Generic Drug Applications in September 2021. The document highlights some questions and answers relating to Bioequivalence (BE) study requirements
read more...NPRA Malaysia Issues Updated Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption
National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued an updated guideline on clinical trial import licence (CTIL) and clinical trial exemption (CTX) in September 2021.
The updated guideline includes some information on First-in-Human (FIH) studies, and NPRA has decided
read more...Philippines FDA Issues Circular on Revised Post-Marketing Surveillance Requirements for New Drugs under Monitored Release
The Philippines Food and Drug Administration (FDA) has issued Circular No. 2021-020 to provide updated post-marketing surveillance (PMS) requirements for new drugs under monitored release, streamlined with Administrative Order (AO) No. 67 s. 1989 “Revised Rules
read more...