In China, the regulating Health Authority is  The National Medical Products Administration (NMPA) also formerly known as the China Food and Drug Administration or CFDA). The NMPA is a vice-ministerial-level administrative agency under the State Administration for Market Regulation (SAMR).

It is responsible for creating and supervising the implementation of policies, plans and standards governing the quality and safety of drugs, cosmetics, and medical devices. The NMPA also oversees standards-setting, registration, and quality management of drugs, cosmetics, and medical devices, as well as post-market inspection and risk management and registration of licensed pharmacists.

Please note that it is not possible for foreign companies to make administrative arrangements for issuing of pre-market approvals directly with the NMPA. Foreign companies shall have partner companies legally constituted in China that will be legally responsible for the products imported to and distributed in the People’s Republic of China.

Regulations

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