Healthcare Regulatory Authorities in China

Healthcare Regulatory Authorities in China

Regulatory Authorities

The National People’s Congress

Principal responsibilities: The highest legislative body in China that is responsible for enacting national laws.

The State Council

Principal responsibilities: The State Council is China’s highest administrative authority. It formulates and issues administrative regulations to implement national laws.

The China Food and Drug Administration (CFDA)

Principal responsibilities: The CFDA issues regulations, rules and policy plans on the administration and supervision of medical products, food and cosmetics. It also undertakes medical products registration, supervision and inspection and establishes a monitoring system for adverse effects of medical products.

The National Health and Family Planning Commission

Principal responsibilities: This Commission formulates and implements administrative measures for medical institutions and medical services industry.

The National Development and Reform Commission

Principal responsibilities: This Commission recommends strategies for national economic and social development and productivity allocation, including price policies, price supervision and anti-monopoly, foreign capital and overseas investment.

The State Administration for Industry and Commerce

Principal responsibilities: The State Administration for Industry and Commerce regulates the market through administrative enforcement. It also issues rules, regulations and policies on the administration of industry and commerce and carries out and administers the registration of enterprises and other legal entities. It is also responsible for the investigation and bans on unlicensed business operations according to the law.

The General Administration of Quality Supervision, Inspection and Quarantine (GAQSIQ)

Principal responsibilities: GAQSIQ is in charge of national quality, metrology, entry-exit commodity inspection, certification and accreditation, and standardisation. It is also in charge of enforcing administrative law and is especially engaged in organising the enforcement of the QS mark system, drafting and implementing the catalogue of products subject to compulsory certification and safety licence system.

Online resources

China Food and Drug Administration (CFDA) (Chinese website)

Description: This is the Chinese language official website owned by the China Food and Drug Administration (CFDA), which provides the organisation’s regulations, procedures and policies. It also provides the most up-to-date medical product administration-related laws and regulations.

China Food and Drug Administration (CFDA) (English website)

Description: This is the English language official website owned by the China Food and Drug Administration (CFDA), which provides a selection of English-language laws and regulations. The English translations are for reference only, and have no binding effect. For some laws and regulations recently amended in 2014 and 2015 there is no English translation available yet.

Chinalawinfo

Description: This website provides a professional Chinese law database maintained by Peking University Centre and Legal Information and Chinalawinfo Co. Ltd., which includes the most up-to-date laws and regulations in the Chinese language and well-selected cases.

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