Studies On The Supervision Status And Solutions Of Medical Devices Market In Hainan Province

In recent years,the industry of medical devices is developing fast,which gave a pushing effect on the economy of our country.Supervising medical devices plays an important role in ensuring the safety and effectiveness of products,protecting the health of customers as well as orders of market.The producer,seller and user of medical devices have been realized the aim and significance of supervision,with the propaganda of medical devices safety and introduce of related laws and regulations by government.Meanwhile,medical devices supervision is also an important job of CFDA.However,the supervision environment changes with the industry development.Since 2014,the Sate Council issued revised?The Regulations on the Supervision and Administration of Medical Devices?,followed with a lot of related rules and regulations.Meanwhile,the government started to push revolution of"Decentralization,Supervision,Service",and CFDA system changed a lot,which brings new difficulties of medical devices supervision in Hainan Province.So study of medical devices supervision has practical guiding significance,and it is beneficial to change supervision concept,improve supervision method and raise supervision efficiency.This research starts from the concept of medical devices,elaborates the changes in system and regulation of medical devices supervision in Hainan Province.Issues of medical devices supervision in Hainan Province include imperfection in legislative system and institutional setup,covertness of irregularity action,weakness of technical support,relaxed execution of the Quality Management Practices,inundation of illegal advertisements,straggling and large number of small-sized enterprises,as well as overlap of government functions are summarized through the method of literatures and visiting investigation.Thus,the author gives out 8 suggestions based on the analysis of above issues:(1)increasing the improving of the supervision of regulatory system of medical devices;(2)deeply digging out of the illegal clues,strengthening crack down on crime;(3)improving institutional setup and personnel quality;(4)strengthening technical support of medical devices supervision;(5)executing Quality Management Practices strictly,strengthening the whole procedure of supervision of medical devices;(6)ensure of joint conference system,focusing on supervision of illegal medical devices ads;(7)strengthening the self-discipline of enterprises and publicity of supervision;(8)optimizing government functions,pushing forward reform.An elaboration is also made based on these 8 suggestions,which provides a reference of medical devices supervision in Hainan Province.