Phone Numbers:
English
+852-8176-7200
UK/Europe
+44(20)3287-6300
Australia
+61(2)6100-3000
USA/Canada
+1(352)275-5900
Brazil
+55(21)3010-9400
Mexico
+52(33)8421-1900
Dear visitor, JavaScript needs to be enabled for viewing this site properly. | Home | Medical Device | Imported Products | Drug Law | Food | Cosmetics |
As of 21 March 2010, a Single EU/EC European Authorised/Authorized Representative must be designated by a non-EU manufacturer of medical devices as required by directive 2007/47/EC, are you ready?
Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic Medical Devices with MHRA & other EU/EFTA authorities by world-leading CE Marking Specialists based in London/UK. Click to get FREE Guide Now!
SFDA of China
As part of the government restructuring announced in March 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. 
In 2003, the SDA was restructured to become the State Food and Drug Administration (SFDA). Other former functions of the ministry have been assigned to different government bodies. The most important of these was the transfer of medical insurance responsibilities to the new Ministry of Labor and Social Security. Nonetheless, the Ministry of Health retains its other main functions-regulatory development and oversight, healthcare resource allocation, and medical research and education. The Chinese government's establishment of a single drug regulatory authority was an important step toward foreign access, because it eliminated the conflicting standards that prevailed among provincial government agencies, centralized the Chinese healthcare regulatory system, and made it more transparent. SFDA now oversees all medications-both Western and TCM-as well as advertising. 
SFDA's new regulations follow US FDA's model. In July 1999, as part of medical insurance reform, SFDA released its first list of over-the-counter (OTC) medications, and in 2000, the state began to regulate OTC and prescription drugs separately. SFDA did so to encourage patients to purchase OTC medicines for less serious diseases, thereby reducing government medication expenditures and hospital visits. The SFDA plans to cut the number of manufacturers down to around 2,000 over the next two years by attrition and by requiring remaining firms to meet the new GMP standards. In fact, SFDA required all pharmaceutical companies in China to obtain GMP certificates from SFDA by June 30, 2004 to be licensed to sell their drug products in China. About 3000 of the companies met the deadline; companies in the process of obtaining certification may subcontract secondary production to a certified company until June 30, 2005.
In 2005, SFDA launched a regulation on drug research and supervision management aimed at enforcing GLP to investigative drugs, traditional Chinese