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Quick Asian Medical Device Regulatory News Briefs

India’s DCGI, on January 6 revised the device classification of 4 main device categories.  These categories include 186 interventional radiology devices, 114 radiotherapy devices, 75 Oncology devices, and 803 Class A Non-Sterile and Non-Measuring devices. Please remember that India classifies medical devices... Read More

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AI Transforming Patient Care and Operations Across Asia

Artificial intelligence is transforming healthcare in Asia: improving the quality of care, facilitating operational efficiency, and increasing patient access. For example, the National University Health System (NUHS) in Singapore uses AI to accurately predict how long patients will stay in the hospital,... Read More

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Malaysia a Tough Drug Market to Crack

Malaysia’s drug market is growing at about 6% per year, but not easy to succeed in. First of all, registering foreign drugs in Malaysia takes a long time and is fairly demanding on the regulatory front. Second, generally, the existing IP protection... Read More

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Quick Asian News Briefs

In late March, the Philippines FDA (PFDA) has extended the registration date for Class B,C and D medical device registration for devices that were not already on the registrable medical device list. Now, these medical devices do not need to be registered until... Read More

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Malaysia Medical Device Update 2024

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

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Malaysia Promulgated Medical Device Exemption Order

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