Compliance with Malaysia Medical Device and Pharmaceutical/Drug Regulations

The Ministry of Health has the National Pharmaceutical Control Bureau (NPCB) and the Medical Devices Bureau set up to regulate drugs and medical devices, respectively.

Some of the main pharmaceutical/drug regulations include the following:

Drug Registration Guidance Document
ASEAN Guidelines
Malaysia Guidelines for the Conduct of Bioavailability & Bioequivalence Studies

For medical devices, registration is under the Voluntary Registration for Medical Devices Establishment (MedVER) system. This system has been voluntary for quite some time, primarily focused on enterprises dealing with medical devices in Malaysia such as importers and distributors.

Pacific Bridge Medical can ensure your company is compliant with the applicable Malaysian pharmaceutical/drug and medical device regulations and develop the right business and/or regulatory strategy for your product. We can also help you register your medical product in Malaysia.

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