As part of the aim to facilitate the efficient development and timely registration of beneficial innovative therapeutic products (chemical and biologic compounds) and cell, tissue or gene therapy products (CTGTPs)
Regulatory News
Singapore HSA Introduced New Self-Help Tool for Grouping of Medical Devices
On 25th February 2021, the Medical Devices Branch (MDB) has introduced a new self-help tool to guide in grouping of medical devices for purposes of premarket registration. This medical device grouping tool will
Thailand Releases New Regulations on Medical Devices
New regulations came into effect on 15 February 2021 to harmonise Thailand’s Medical Device Act with the ASEAN Medical Device Directive.
In the past, a majority of the medical device are under the
Vietnam MOH Implements Online System to Maintain Validity of Drug Licences
The Ministry of Health Vietnam has issued on 03 February 2021, Official letter No. 777/QLD-DK regarding implementation of online system to maintain the validity of drug licences.
The Drug Administration of
Malaysia NPRA Strengthens Regulatory Control of Medicinal Gases Classified as Drugs
Malaysia NPRA issues Directive 8 of 2021 on Strengthening of the Implementation of Products Regulatory Control – Medical Gas Products and the Use of Guideline on Registration of Medicinal Gases.
To
Australia TGA Releases New Standard for Medicines with Data Matrix Codes or Serialisation
A new standard clarifying requirements for serialisation and data matrix codes on medicines supplied in Australia commences on 1 January 2023. The Therapeutic Goods (Medicines – Standard for Serialisation and
Australia TGA Changes ARTG Inclusion Process for Class 1 IVD Medical Devices
On 4 December 2020, the TGA inclusion process for Class 1 in vitro diagnostic (IVD) medical devices in the Australian Register of Therapeutic Goods (ARTG) changed. This follows similar changes
Singapore Health Sciences Authority Updates the Guidance for Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products
Singapore Health Sciences Authority has updated the Guidance for Industry: Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products (CTGTPs). The main updates
Australia TGA Published Regulatory Changes for Software Based Medical Devices
Australia TGA published a summary of regulatory changes to the regulation of software-based medical devices (including software as a medical device – SaMD) that take effect from 25 February 2021.