February 2023

Drive-by transaction sale

Philippines: Online Selling Of FDA Certified COVID-19 Self-Administered Test Kits

The Philippines Food and Drug Administration (FDA) issued an advisory, lifting the prohibition of online selling of FDA Certified COVID-19 Test Kits including Self-Administered COVID-19 Test Kits, pursuant to FDA Advisory No. 2022-0107-A Lifting of the FDA Advisory No. 2022-0107 entitled “Reiteration on Prohibition of Online Selling of FDA Certified COVID-19 Test Kits including Self-Administered […]

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Cyber security analyst working on a laptop

Singapore: Announcement: Public Consultation For The Proposed Framework And Implementation Of The Cybersecurity Labelling Scheme For Medical Devices, CLS (MD)

As ‘smart’ medical devices are commonly used in the health settings with increased connectivity to the cyber world, it’s inevitable to have an increased potential risks of cyber-attacks as well. Thus, at the Singapore International Cyber Week 2022, the Ministry of Health (MOH), Cyber Security Agency of Singapore (CSA), Health Sciences Authority (HSA), and the

Singapore: Announcement: Public Consultation For The Proposed Framework And Implementation Of The Cybersecurity Labelling Scheme For Medical Devices, CLS (MD) Read More »

In-vitro diagnostic equipment

Thailand: Collaborative Registration Procedure (CRP) of Thailand FDA – WHO for In-Vitro Diagnostic Products

The Medical Device Control Division, Thai FDA has been recognized by WHO as a reference agency, which allows Thailand to participate in the Collaborative Registration Procedure (CRP) program, that can shorten the duration of registration. The Thai FDA will assess the performance and safety of the medical device in cooperation with the WHO’s evaluation report.

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Rubbed stamp 'revised'

Malaysia: MDA Released Second Edition Guidance Documents for Medical Gas System-Requirements for Registration

Malaysia’s Medical Device Authority (MDA) released a guidance document for the requirements of MEDICAL GAS SYSTEM – REQUIREMENTS FOR REGISTRATION. This guidance document will serve as a revised version of MDA/GD/0057 that was released in June 2020, which provides information on the requirements for registration of medical gas system “placed in market” as defined in

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