06/03/2013
SFDA of China
If an American medical device company wants to do business in China, it has to register its products under Chinese State Food and Drug Administration (SFDA). SPINE has helped many companies went through this process smoothly. If any companies are interested in doing business in China and register their products, SPINE will serve their interests.
SFDA's regulations follow US FDA's model. Main Responsibilities of the SFDA
1. To organize relevant authorities to draft laws and regulations on the safety management of food, health food and cosmetics; organize relevant authorities to formulate comprehensive supervision policy, work plan and supervise its implementation.
2. To exercise comprehensive supervision on the safety management of food, health food and cosmetics in accordance with laws; organize and coordinate supervision work on the safety of food, health food and cosmetics carried out by relevant authorities.
3. To organize and carry out investigation and impose punishment on serious safety accidents of food, health food and cosmetics; delegated by the State Council, organize, coordinate and conduct specific law-enforcement campaigns over safety of food, health food and cosmetics nationwide; organize, coordinate and collaborate with relevant authorities in carrying out emergency rescue work on serious safety accidents of food, health food and cosmetics.
4. To comprehensively coordinate the testing and evaluation for the safety of food, health food and cosmetics; formulate provisions on releasing of supervision information for safety of food, health food and cosmetics in conjunction with relevant authorities and monitor their implementation; sum up safety information of food, health food and cosmetics from relevant authorities and release it to the public regularly.
5. To draft law and administrative regulations on drug administration and supervise their enforcement; carry out protection system for certain traditional Chinese medicinal preparations and administrative protection system for pharmaceuticals in accordance with law or regulations.
6. To draft law and regulations on administration of medical devices and supervise their enforcement; take charge of registration and regulation of medical devices; draft relevant national standards, draw up and revise professional standards of medical devices, manufacturing practice and supervise their implementation.
7. To be in charge of drug registration, draw up, revise and promulgate national standard of drugs; draw up criteria for marketing authorization of health food; review and approve health food; set up classification system for prescription drugs and OTC drugs; establish and improve ADR monitoring system; be responsible for drug reevaluation, review drugs to be withdrawn and formulate national essential medicines list.
8. To draft and revise good practices for drug research, manufacturing, distribution and use, and supervise their implementation.
9. To control the quality of drugs and medical devices in manufacturers, distributors and medical institutions; release national quality bulletin on drugs and medical devices on a regular basis; investigate and punish illegal activities of producing and selling counterfeit and inferior drugs and medical devices in accordance with law.
10. To regulate radioactive pharmaceuticals, narcotics, toxics, psycho -tropics, and other controlled drugs and devices in accordance with law.
11. To draw up and improve qualification system for licensed pharmacist, supervise and direct the registration of licensed pharmacist.
12. To direct national drug regulation and comprehensive supervision on the safety management of food, health food and cosmetics.
13. To carry out exchanges and cooperation in drug regulation, relevant safety management of food, health food and cosmetics with foreign governments and international organizations.
14. To undertake other work assigned by the State Council.
