What laws and regulations apply to the manufacture and sale of pharmaceuticals and medical products in China?

The laws and regulations for the manufacture and sale of pharmaceuticals and medical products in China are extensive. Manufacturers must obtain the products’ national drug approval and production license from the China Food and Drug Administration (CFDA). Furthermore, they must also obtain provincial or municipal drug production permits. Good Manufacturing Practices (GMP) must be in place to ensure product safety and quality. In addition, manufacturers must also comply with China’s Pharmacopoeia regulations, which establish national standards for drugs and pharmaceutical raw materials. For medical products, the China Food and Drug Administration (CFDA) regulates the marketing, production, and sale, as well as overseas medical product registration. All medical products must comply with the Technical Specification for Safety and Quality of Medical Devices regulations, which provide requirements for the production, safety inspection, operation and maintenance of medical devices. In order to receive medical device registration from the Food and Drug Administration (CFDA), manufacturers must provide documents such as a product registration certificate, product testing report, and quality system documents. Furthermore, certain products must submit additional documents such as clinical trial results and medical device evaluation reports. Overall, the laws and regulations for the manufacture and sale of pharmaceuticals and medical products in China are extensive and must be followed to ensure safe and quality products. Compliance with the various regulations is necessary to obtain the necessary national drug approval and production license from the China Food and Drug Administration (CFDA).

What laws and regulations apply to the manufacture and sale of pharmaceuticals and medical products in China?

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