On 18 February 2021, Thai FDA announced that any GMP clearance approval letter which was approved before the date of this announcement will have their validity extended to April 2022
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Malaysia MDA Issues Guidelines for Application for Medical Device Advertisement Approval – Requirements
This guideline specifies the requirements for advertisement of medical devices that require approval and no approval required.
The following materials are controlled through self-regulation, and shall comply with the requirements of
read more...Philippines FDA Starts Pilot Implementation of eServices Portal System for Drug Products
The Philippines FDA, in its commitment to provide stakeholders with streamlined and improved government services, is developing the FDA eServices Portal System – an online platform for FDA marketing authorization
read more...Australia TGA Updates Comparable Devices in the Clinical Evidence Guidelines For Medical Devices
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
read more...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
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