Malaysia, with close to 34 million people, is a good market for Western medical device exporters. The Malay Medical Device Authority (MDA), which falls under the Ministry of Health (MoH), registers devices. Malaysia, like the other ASEAN countries, has 4 classifications for... Read More
On March 6, 2024, Malaysia issued Medical Device Exemption Order 2024, superseding the previous Exemption Order from 2016. This regulatory overhaul introduces an expanded framework for the exemption of certain medical devices from the registration mandate under the Medical Device Act 2012. The... Read More
Submission of applications to the Japanese authority now mandates usability engineering. The international standard IEC 62366-1, governing usability engineering in medical device development, transitioned into a JIS standard in 2019 and was updated as JIS T62366-1:2022 in February 2022. JIS T 62366-1... Read More
The Malaysia Medical Device Authority (MDA) has introduced a landmark guidance document aimed at streamlining post-market surveillance and data exchange across the Association of Southeast Asian Nations (ASEAN). This initiative, outlined in the guidance MDA/GD/0067, is in response to the collective decision... Read More
Japan’s PMDA will open its first overseas office in Bangkok in 2024 or at the latest by March 2025. The new PMDA office will interact with Southeast Asian countries and hopefully improve their knowledge of Japanese requirements. China removes tariffs on 62... Read More
A recent report by Bain & Company and APACMed (a MedTech trade association located in Singapore) has issued a report on Asian MedTech companies’ growing appetite for ESG initiatives. According to this report, the Asia region has doubled its ESG policies compared... Read More
Last month, we reported on new consultation services for medical device registration applicants in Malaysia. This month on September 6, Dr. Muhammed Radzi, Malaysia’s Health Ministry Director General announced that Malaysia’s online application system will be upgraded to the MeDC@St 3.0 application... Read More
In the past, it was not possible to meet Malaysia MDA officers face-to-face. They were always resource-constrained and did not have time. However, on August 2, Malaysia’s MDA announced new consulting services for device manufacturers seeking medical device registration approval in Malaysia.... Read More
Overview and History Malaysia presents a robust and influential market for foreign medical device and drug companies looking to expand their presence to Southeast Asia. The oversight of medical devices in Malaysia falls under the Medical Device Authority (MDA), which operates as... Read More
To register devices in Malaysia, you must make a dossier submission according to the required items in the Medical Device Act of 2012, and the specific instructions outlined on the Malaysia Medical Device Authority (MDA) website. Starting May 1, the MDA changed... Read More