Regulatory Strategy for Medical Devices and Pharmaceuticals/Drugs in Malaysia
In Malaysia, drugs must be registered with the National Pharmaceutical Control Bureau (based on their Malaysian name) before marketing. Medical devices can be registered with the Medical Device Bureau through MeDVER, but that is an optional process. By 2010, however, Malaysia is expected to make registration mandatory for medical devices.
For more information on regulatory issues in Malaysia, please see the following PBM publications and/or contact us to discuss your specific needs.
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