中山市TBT預(yù)警防控平臺(tái)
——技術(shù)性貿(mào)易措施資源
Regulatory history and authorities
時(shí)間: 2020-10-21
In China, the Ministry of Health (MOH) is responsible for policy and regulations relating with healthcare issues, which sets up national policies and coordinates healthcare resources. In 1998, the Ministry of Health's Department of Drug Administration merged with the State Pharmaceutical Administration of China (SPAC) to become the State Drug Administration (SDA). As a result, SDA oversees all drug manufacturing, trade, and registration. The SDA was then restructured to become the State Food and Drug Administration (SFDA) in 2003. After that, SFDA became the China's national regulatory body responsible for all medications as well as advertising.SFDA is directly under the State Council of the People's Republic of China, which is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority for drug and medical devices regulation.
Nonetheless, the MOH retains its other main functions, such as the regulation development and oversight, healthcare resource allocation, and medical research and education. The establishment of SFDA follow U.S. FDA’s model, which eliminated the conflicting standards, centralized the Chinese healthcare regulatory system and made regulatory process more transparent by establishing a single authority.
SFDA is China's national regulatory body responsible for medical device regulation. In some situations, the SFDA shares regulatory control regarding medical devices with the MOH. The SFDA also confers power to regulatory authorities of provinces, autonomous regions, and municipalities[1].
Main responsibilities of SFDA pertaining to medical devices include:
l To formulate policies and programs on the administration of medical devices and supervise their implementation; to bear a part in drafting relevant laws, regulations and normative documents;
l To take charge of administrative and technical supervision of medical devices, take charge of formulating good practices for medical devices in aspects of research, production, distribution and use, and supervise their implementation;
l To take charge of registration and supervision of medical devices; draw up relevant national standards of medical devices, and supervise their implementation; carry out the adverse event monitoring of medical devices; be responsible for medical device re-evaluation and elimination;
l To supervise the quality and safety of medical devices, to regulate radioactive pharmaceuticals, narcotics, toxics and psychotropics, and release quality and safety information of medical devices;
l To organize the investigation and punishment of illegal activities on research, production, distribution and use of medical devices;
l To undertake other work assigned by the State Council and the Ministry of Health.
For more information please contact 86-755-83997910 or email to wrr@sist.gov.cn
[1] Medical devices law & industry report. 2011. The Bureau of National Affairs, Inc.