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
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
Device registration in Malaysia is aided by prior approval in the EU/US. An EC Certificate (EU CE Marking) or EC Declaration of Conformity is recognized by the Malaysia Medical Device Authority (MDA) as an approved type for the conformity assessment process for... Read More
For drugs already approved in Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) under the Malay Ministry of Health, has set up a new pilot program where additional drug indications can be approved if such indications have been approved by certain foreign MOHs.... Read More
In response to the outcomes of the MDA-CAB 2024 Workshop held on March 1, 2024, significant changes are underway in the medical device certification/registration process in Malaysia. According to an email from the Medical Device Authority (MDA) dated April 1, 2024, new... Read More
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
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