The China Food and Drug Administration or CFDA is the Chinese agency for regulating food, drugs and medical devices. The predecessor to the CFDA was founded in 1998 to initially oversee drugs and medical devices. When it was given jurisdiction over food in 2003, it was renamed the State Food and Drug Administration and reported to the State Council. Following a series of scandals in 2008, the regulatory body was put under the supervision of the Ministry of Health (MOH). Formerly known as the State Food and Drug Administration (SFDA), the CFDA was restructured in March 2013 and elevated to a ministerial-level agency.
The China Food and Drug Administration is now part of the State Council of the People's Republic of China, the country’s highest regulatory body that oversees the introduction of food, health products and cosmetics in mainland China. Its responsibilities include drafting laws and regulations for food safety, drugs, medical devices and cosmetics as establishing medical device standards and classification systems. For a full list of responsibilities, please consult this entry on the CFDA website.
The CFDA departments dealing with medical devices are:
- Department of Medical Device Registration, responsible for pre-market approvals
- Department of Medical Device Supervision, responsible for post-market supervision
Some of the most important regulations for medical devices in China are:
- Regulations for the Supervision and Administration of Medical Devices (PDF)
- Medical Device Classification Provisions - SDA Order No 15
- Initial Registration of Imported Medical Devices
A full list of CFDA regulations can be found here.
- Website: http://eng.sfda.gov.cn/
Medical Device Associations in China: