November 2021

Abridged registration in the philippines

Abridged registration process for ASEAN registered medical devices in the Philippines

Abridged processing for applications of registration or notification of medical devices in the Philippines was introduced on 25 November 2021 as the Food and Drug Administration (FDA) issued Advisory No. 2021-3084. The introduction of this advisory means that medical devices that have already been approved by the regulatory authority of another ASEAN member country will …

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Malaysia requirements for supplying Covid-19 self test kits

Requirements For Supplying Covid-19 Rapid Self-Test Kits In Malaysia

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 to the guidelines for conditional …

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Vietnam draft Decree on medical device management

Vietnam draft Decree to unify and simplify regulations on the management of medical devices and equipment.

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 management, the Ministry of Health …

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Singapore publishes Artificial Intelligence in Healthcare guidelines

Singapore publishes Artificial Intelligence in Healthcare Guidelines (AIHGIe)

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 the healthcare industry. The scope …

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Malaysia conditional permission COVD19 self-test kits

Conditional permission for the import & distribution of Covid-19 self-test kits into Malaysia

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 on the MDA website on …

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New post marketing surveillance combined products Malaysia

New Post Marketing Surveillance procedures for Combination Products in Malaysia

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 registered combination products by the …

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