TGA has issued version 2.0 of Clinical evidence guidelines: Medical devices in March 2021 to update the section on Comparable devices including substantially equivalent devices.
The first step in the comparability
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Thailand Releases New Regulations and Guidelines on Report of Device Defects, Adverse Events Occurred to Consumers, and FSCA of Medical Devices
5 documents have been released by the Ministry of Public Health and Thai FDA regarding revised reporting of device defects, Adverse Events Occurred to Consumers, and FSCA of Medical Devices.
read more...Taiwan FDA to Start Pilot Testing of eCTD Submissions
On 22nd March 2021, Taiwan FDA announced a plan on pilot testing of eCTD submission.
To ensure that the eCTD submission platform functions smoothly, Taiwan FDA will conduct pilot testing
read more...Singapore HSA Launches Innovation Office to Support Product Development
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)
read more...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
read more...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
read more...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
read more...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
read more...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
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