June 2023

Person wearing medical gloves holding a COVID-19 test kit

Malaysia: MDA Withdrawn the Guidance Document: MDA/GD/0059 for COVID-19 RTK (SELF – TEST) – REQUIREMENTS 

The Medical Device Authority of Malaysia (MDA) withdrawn the guidance document MDA/GD/0059 for COVID-19 RTK (SELF – TEST) – REQUIREMENTS from the MDA website on June 8, 2023. The guidance document was initially established and published with the intention to give specific requirements for conditional approval of Covid-19 RTK (self-test) to be placed in the […]

Malaysia: MDA Withdrawn the Guidance Document: MDA/GD/0059 for COVID-19 RTK (SELF – TEST) – REQUIREMENTS  Read More »

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Singapore: The HSA Recognized By WHO As Stringent Regulatory Authority (SRA) For High-Risk In Vitro Diagnostic Medical Devices (IVDs)

The Health Sciences Authority (HSA) of Singapore has been recognized by the World Health Organization (WHO) as a WHO Stringent Regulatory Authority (SRA) for high-risk (Class C and D) in vitro diagnostic medical devices (IVDs). The HSA joins the five founding members (European Union, The United States, Canada, Australia, and Japan) of Global Harmonisation Task

Singapore: The HSA Recognized By WHO As Stringent Regulatory Authority (SRA) For High-Risk In Vitro Diagnostic Medical Devices (IVDs) Read More »

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Malaysia: MDA Announced Enforcement of Payment for all Subsequent Notification Clinical Research Use in MeDC@St 2.0+

The Medical Device Authority of Malaysia (MDA) announced that enhancements have been made to the MeDC@St 2.0+. For notification module, an improved features have been added to the Clinical Research Use sub-module as follows: The online form has a new look and allows batch uploads on medical device listings. Print Application that allows printing of

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