Regulatory Strategy for Medical Devices and Pharmaceuticals/Drugs in Malaysia
Malaysia is a medium-sized country in Southeast Asia with about 25 million people.
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.
- Looking East for R&D and Clinical Trials
- ASEAN Medical Device Harmonization Trends (webcast for sale)
- A Regulatory Update on Asia's Smaller Medical Device Markets
- Drug, Device and Cosmetic Regulations in Malaysia: 2005 Update
- Regulatory Update on Malaysia's Medical Markets
- Regulatory Updates for Medical Devices in Asia (PDF)
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