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 medical devices – A, B, C, and D. Sometimes, the classification and grouping criteria in Malaysia is somewhat different from those used in the EU. For low-risk class A products, the applicant can apply directly online via the MeDC@St system. For Class B, C, and D devices, documents first need to be submitted to a Conformity Assessment Body (CAB). If the specific device already has approval from the US, EU, Australia, Canada, or Japan, the CAB will only verify the appropriate documents. If foreign approval from these countries is not available, the CAB will do a full assessment. Once the CAB certificate is obtained, a second application to the MDA will be made.

Class A medical device registration process in Malaysia is outlined below. This process usually takes 6 to 8 weeks.

Class B, C, and D medical device registration process is outlined below. This process usually takes 3 to 6 months.

Once the device is approved by the MDA, the foreign device manufacturer or its local agent needs to make sure the product certificate number if on the product label and connect with a Malaysian importer/distributor. Then, the manufacturer will issue a Letter of Appointment (LoA) to their Malaysian distributor.

Product registration fees for the CAB and MoH are outlined below.

CAB Fees MOH Fees
Class A n/a MR100
Class B MR1,300 MR1,250
Class C MR1,300 MR2,500
Class D MR1,300 MR3,750
Combination Device MR1,300 MR5,750

Malaysia has implemented some new measures to help expedite device registration and more closely align with the ASEAN Medical Devices Directive (AMDD). First, it is now possible to have meetings with the MDA whereas in the past, this was not allowed. The MDA offers two consultation programs – 1. A consulting package that has 5 different programs and 2. A non-specific package where some of the topics in a consulting package can be explored plus other programs like specific labeling required, etc.

Second, the MDA has reduced the time that applicants can respond if their initial submission was not accepted because it was incomplete. The response time has been reduced from 90 to 30 days.

Third, Malaysia has upgraded its online application system to MeDC@St 3.0. This new online system will be implemented in various phases in 2025 to bolster cybersecurity and digitalization.

Fourth, instead of paper approval certificates, the MDA has begun providing certificates of registration electronically.

Finally, the MDA has promulgated a new document outlining ways to improve and expedite post-marketing surveillance. Also, they have announced more efficient strategies to coordinate post-market data with other ASEAN countries. Now, dangerous devices and adverse events will be shared within ASEAN to protect public health.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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