China's State Food and Drug Administration (SFDA)

Founded in 1998, the SFDA is responsible for the regulation and management of medical devices and drugs in China. Headquartered in Beijing, the administration is divided into ten departments under the State Council, three of which share responsibility for regulating medical devices and drugs: the Department of Medical Device Supervision, the Department of Drug Registration, and the Department of Drug Safety and Inspection.

The Department of Medical Device Supervision creates national medical device standards and oversees their implementation, controls registration and regulation of medical devices, regulates production and distribution of medical devices, writes the national classification list for medical devices, formulates good practices for clinical trials, and oversees reevaluation and termination of licenses.

The Department of Drug Registration oversees drug registration and formulates national drug standards, requirements for usage, processing standards for crude Chinese drugs, and standards and requirements for clinical and non-clinical trials.

The Department of Drug Safety and Inspection creates and oversees good practices and regulations for pharmaceutical preparations in medical institutions and crude Chinese drug production, manufacturing and distribution. Additionally, it draws up the national essential medicines list, the drug classification system, and supervises narcotics, psychotropics and other restricted drugs. Licensing and reevaluation of pharmaceuticals also fall under its domain.

In order to ensure compliance with the product standards formulated by each department, the SFDA supervises their implementation through pre-market testing and post-market surveillance. If adverse events or breaches of standards occur, the SFDA is authorized to investigate manufacturers, recall products and administer penalties when necessary.

The SFDA also publishes and revises good practice guidelines for the research, manufacture, and distribution of drugs and medical devices. In order to promote international regulatory harmonization, the SFDA often consults and conducts exchanges with foreign governments and international organizations.

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