Research On My Country's Medical Device Registration Management System

As special commodities,medical devices are used on human directly or indirectly,thus their quality has a big impact on public health and social harmony.In recent years,changes in the technology of medical devices have bring new hopes to the precaution,therapy and diagnosis of major disease,and the fast development of medical device industries gave chanllenges for the government.In order to assure the safety and performace of medical devices,China adopts premarket evaluation to the market access of medical devices.The thesis gave definition to medical devices premarket evaluation,and deemed it as a standalone system.Based on the System theory,a study was made on theelements,structure and enviorement of the system.As a result,the premarket evaluation system is consisting of four elements:laws and regulations,technical guidance,regulated product submission and review offices.The function of the system is to make systematical evaluation on the safety and performace of the medical devices based on their reseach data and results,thus to decide whether to allow the medical devices’ market access.Firstly,Food and Drug Administration(FDA),Euopean Commission(EC)and International Medical Device Regulators Forum(IMDRF)was chosed as objects,and five points are found to be enlighening,they are:①FDA Critical Path Initiave is a method to improve the premarket evaluation system;②Essential principles of safety and performance(EP)are the core requirements of the premarket evaluation;③IMDRF regulated product submission may improve the systematic of the premarket evaluation;④FDA guidance may improve the efficacy and scientical of the premarket evaluation;⑤IMDRF and EC assessment method for the recognition and monitoring of medical device review organizations may improve the uniformity and quality of the premarket evaluation.Secondly,current status is studied on the premarket evaluation in China.Based on the Legal Permission principles,six problems are found to be serious,they are:①the law and regulations are incomplete;② the evaluation scale of the review origanizations is not consistent;③the quality of the review origanizations is not satified;④the requirements on safety and performance are absent;⑤the regulated product submission is not put together in a systematic way;⑥the guidance system is insuffcient.Based on Critical Path Method and Program Evaluation and Review Technique,a study was made on the estimated time and efficacy of the premarket evaluation system,and it comes to the result that the review orgnizations are the critical factors.Finally,based on the Muddling Through theory,four solutions are offered,they are:①Based on literature study method,EP was put into regulation in the means of checklist,which clarify the requirements of legal permission.② Based on comparative study method,regulated product submission of GHTF,IMDRF and China are studied,thus build our regulated product submission with EP as the core,which improved the systematic.③Based on comparative study method and inductive method,guidances by FDA was studied,thus "standard operation procedure for medical device guidance" was composed,and our medical device guidance system was build,which solved the longlasting "plan,compose,application" problems.④Based on comparative study method and peer review method,IMDRF and EC assessment method for the recognition and monitoring of medical device review organizations was studied,and for the first time,an evaluation system is built,which is used to assess the medical devices review organizations in China.The system is consisted of 10 dimensions,29 items and 76 indicators,which made a solid foundation to the reform of review organizations in our country.For the first time,a systematic study was conducted on the medical devices premarket evaluation system,and the results were formally applied in revelant fields such as regulation,which have provided valuable reference to the reform of premarket evaluation in China.