Medical Device and Pharmaceutical Regulatory Affairs and Quality Consulting for China
China is one of the largest and rapidly growing economies in the world today. With economic expansion and increased affluence, both the medical device and pharmaceutical markets in China continue to experience enormous growth. GRP office on the ground in Shanghai can effectively assist Western medical companies on the ground with several issues, ranging from navigating the Chinese regulatory system to building a winning business strategy for the Chinese market.
|China Medical Device Market Size||China Pharmaceutical Market Size|
|$19 billion||$110 billion|
|Projected Growth Rate: 7.5%||Projected Growth Rate: 7.5%|
|China Economic Indicators|
|GDP (PPP): $19.5 trillion|
|Per Capita GDP (PPP): $14,200|
|Real GDP Growth Rate: 6.8%|
|Population (millions): 1,370|
|Ethnic Diversity: 92% Han; 8% minority groups|
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.
- The China Food & Drug Administration (CFDA) is responsible for medical devices, drugs, and healthcare services. The organization is headquartered in Beijing, with offices in each province.
- The Center for Medical Device Evaluation (CMDE) is responsible for conducting the dossier review during the medical device registration process.
- The General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) conducts mandatory safety registration, certification, and inspection for certain devices.
For more information, check the CFDA website at: http://eng.sfda.gov.cn/WS03/CL0755/