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
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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...Australia TGA Publishes Finalised Guidance Document on Examples of Regulated and Unregulated Software
Therapeutic Goods Administration (TGA) Australia has published the finalised guidance document on examples of regulated and unregulated software in August 2021.
The guidance document presents examples that illustrate the boundaries between regulated and unregulated software. Software based medical devices are discussed in
China NMPA Implements Drug eCTD Submission
On 30 September 2021, China NMPA issued an announcement No. 119 of 2021 regarding implementation of drug eCTD submission.
From December 29, 2021, applications for marketing authorisation of chemical drug categories 1, 5.1, and for therapeutic
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