| In the 1990 s,China liberalized the access conditions for the pharmaceutical machinery industry(the joint name of drugs and medical devices),and the number of pharmaceutical machinery business units(pharmacies,contact lens stores,etc.)and users(medical institutions,etc.)increased rapidly.At this time,with the rapid growth of the industry,some contradictions and problems such as lagging regulatory policies,frequent safety hazards,unclear main responsibility and single regulatory means gradually surfaced.Guided by the government regulation theory and risk management theory,and based on combing the relevant literature at home and abroad,the paper applies the methods of investigation,interview and literature research to go deep into the drug and equipment supervision team,and conducts field investigation on individual pharmacies,chain pharmacies,medical equipment franchised stores,hospitals and individual clinics in rural areas of Rui’an City,Zhejiang Province,so as to understand the current situation and effectiveness of rural drug and equipment supervision.From the perspective of theory and practice,this paper analyzes the hidden dangers and their causes in the safety of medical devices,and puts forward suggestions from the perspective of the supervisor(government),so as to provide decision-making reference for the safety supervision of medical devices in rural areas of Rui’an City,Zhejiang Province.Research shows that although the safety supervision of drugs and equipment in rural areas of Ruian City has achieved initial results in recent years,there are still some problems,such as filling the market with inferior drugs and equipment,illegal operation of prescriptions,poor effect of adverse reaction monitoring and so on.The reasons include system and mechanism,operators,regulators and consumers,which are closely related to poor traceability of drugs and equipment,lagging management system,fierce industry competition,lack of internal management,insufficient supervision force,low law enforcement efficiency,negligence of group prevention network,weak risk awareness,etc.Aiming at the hidden dangers of drug and equipment safety found in the research,this paper puts forward ten solutions from the four perspectives of establishing an intelligent traceability management system,carrying out targeted industry rectification and standardization,realizing the construction of all-round supervision efficiency and building a diversified social supervision and security system,so as to ensure the safety of "drug box" of ordinary villagers in Ruian countryside and provide reference for the reform of drug and equipment supervision of market supervision departments. |