New requirements for supplying COVID-19 Rapid Self-Test Kits in Malaysia were released by the Malaysian Medical Device Authority (MDA) on 10 November 2021 in Guidance Document MDA/GD/0059. The document guides companies on the requirements to follow in order to place Covid-19 Self-Test Kits on the market. This guidance is separate
Over recent years, the Vietnamese Government has issued various Decrees regulating the management of medical devices including: Decree No. 36/2016/ND-CP dated 15 May 2016; Decree No. 169/ND-CP dated 31 December 2018, and Decree No. 03/2020/ND-CP dated 01 January 2020. However, in order to unify regulations on medical device and equipment
The Ministry of Health (MOH) together with the Health Sciences Authority (HSA) and Integrated Health Information Systems (IHiS) has co-developed a guideline on Artificial Intelligence in Healthcare which was published in October 2021. The guideline aims to promote good practices and encourage safe development and implementation of artificial intelligence in
To alleviate the burden on frontliners and to ease the detection and control of Covid-19 cases, the Health Ministry’s Medical Devices Authority (MDA) has granted conditional permission for the import and distribution of the Covid-19 self-test kits into the country. Circular letter No. 1/2021 dated 14 July 2021 was posted
The Malaysian Medical Device Authority (MDA) has released the 4th edition of Guidelines for Registration of Drug-Medical Device and Medical Device-Drug Combination Products on 25 October 2021. The main changes are the inclusion of new Post Marketing Surveillance procedures for Combination Products in Malaysia namely the management of incidents involving
Vietnam’s Ministry of Health introduced new regulations on 16 September 2021 regulating the issuance of fast-track product licenses and the importation of medical equipment for COVID-19 prevention and control. Circular No. 13/2021/TT-BYT immediately came into effect from the date of signing and is effective until 31 December 2022. The Circular
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