RESUMEN
Based on the theories of the Government Regulation and Administrative Licensure, aiming at the current situations of medical device registration system in China, some policy suggestions for future reform and improvement were provided as follows. (1) change the concepts of medical device registration administration. (2) perfect the regulations of medical device registration administration. (3) reform the medical device review organizational system. (4) Optimize the procedure of review and approval. (5) set up and maintain a professional team of review and approval staff. (6) reinforce the post-marketing supervision of medical devices. (7) foster and bring into play of the role of non-government organizations.
Asunto(s)
China , Aprobación de Recursos , Equipos y Suministros , Administración de Instituciones de SaludRESUMEN
OBJECTIVE:To learn about the advance in the formulation of OTC list in China.METHODS:The background about the prescription drug-OTC drug classification system in China were briefed,the principle and characteristics of the formulation of OTC list were introduced,and the working programmes in next stage were discussed.RESULTS & CONCLUSION:As a vital part of the drug classification system,a OTC list formulation has a lot of work to be done in the future.