In April 2022, the Health Sciences Authority published its revised Regulatory Guidelines for Software Medical Devices. It has also finalised its new Guidelines on Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Software, which had been released for public consultation in July to August 2021.
Given the increasing popularity of direct-to-consumer genetic testing, the Ministry of Health has taken various initiatives to raise awareness of the risks arising from the use of such tests. In addition to various social media advertisements since December 2021 and issuing an advisory for consumers in August 2021, the MOH also issued a guidance document for providers of non-clinical genetic testing in May 2021.
On 27 April 2022, the Health Sciences Authority announced that it detected potent medical ingredients in two products that were marketed on local e-commerce and social media platforms. The HSA has since removed the affected listings and issued warnings to sellers of said products.
The Therapeutic Products Branch and the Health Products Regulation Group of the Health Sciences Authority recently revised its Guidance on Therapeutic Product Registration in Singapore, which took effect on 29 April 2022.
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In March 2022, the Health Sciences Authority released its revised Health Supplements Guidelines. This is accompanied by sets of brand new guidelines regarding (i) claims and claims substantiation; (ii) labelling standards; and (iii) safety and quality standards, which were also released on March 2022.