The manufacture, importation, and sale of medical devices in Malaysia are subject to the requirements of the Medical Device Act 2012 (Act 737). Businesses are required to obtain the relevant licences and product registrations from the Medical Device Authority (MDA) before their medical devices can be legally placed on the Malaysian market.
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The manufacture, importation, and sale of drugs in Malaysia are subject to the requirements of the relevant laws and regulations. Businesses are required to obtain product registration and the relevant licences from the National Pharmaceutical Regulatory Agency (NPRA) before their drugs can be legally placed on the Malaysian market.
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