医疗器械法规和管理课件.ppt

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1、BIMT,with its former name Beijing Medical Device Testing Station,was established in 1983 and it was attached to the former Beijing Medical Equipment Institute.BIMT has reformed into a public institution with independent judicial person since 2000,which was an affiliate of BJDA.Same time It is a subo

2、rdinate agency of SFDA.,-Brief Introduction of BIMT,As a national medical device testing center,BIMT undertakes the assignments such as registration testing,supervision sampling testing of medical device testing,CCC compulsory safety certification testing,testing of import&export commodities,certifi

3、cation testing,entrusted testing and arbitration testing in and out of China.,-Testing Capacity,Content,1.Present situation of CFDA2.Present medical device regulations system3.Present medical device standards system,3,4,Control of all life cycle,Products registration,Manufacturer approved,Surveillan

4、ce for products：such as sampling testing,Recall,Adverse events.,Surveillance for behaviors(GMP):Such as quality systems,distribution,use,disposal,Post market,Beforemarket,MD life cycleR&DManufacture salesuseservicedisposal,Present situation of CFDA,5,China food and drug administration,Department of

5、Medical Device Registration,Department of Medical Device supervision,Registration I,Registration II,General Affairs,General Affairs,Department of Science,Technology and Standards,Research Supervision,Manufacturing Supervision,Distribution Supervision,Division of Monitoring and Re-evaluation,Departme

6、nt of Medical Device Registration,To conduct registration for Class III and import medical devices in strict accordance with the conditions and procedures prescribed by law,take the correspondent responsibilities,optimize registration control procedures,organize and implement classification administ

7、ration,and supervise the implementation of good practices for medical devices.,6,Department of Medical Device Supervision,To track and analyze medical device safety situation and existing problems,and to put forward recommendations on system,mechanism and performance improvement;to supervise the low

8、-level administrative departments in conducting administrative licensing by law,in performing the administrative duty,in detecting and rectifying illegal and improper acts in time;to organize and conduct medical device adverse events monitoring and reevaluation.,7,Department of Science,Technology an

9、d Standards,To organize and implement major science and technology programs for food and drug supervision,accelerate the construction of food and drug testing system,electronic supervision tracking system,and information system;to draft qualification requirements and testing norms governing food and

10、 drug testing institutions,and supervise their implementation;to organize the drafting of standards for drugs,medical devices,cosmetics,and catalogues,pharmaceutical use requirements,standards for immediate packaging materials and containers,and participate in the drafting of food safety standards.,

11、8,Technical Support institutes,Center of Medical Device EvaluationCenter of Medical Device Standards Management Medical Device Standards Technical CommitteesInstitute of Medical Device TestingCenter of Drug Adverse Events Monitoring and Reevaluation.,9,Characteristics of structure reform,Strengthen

12、post market supervisionStress on R&D and standards,10,Medical device regulation system,11,Regulation,Normative Document,Guidances,Regulations for the Supervision and Administration of Medical Devices,ORDER NO.101516,Order,provisionlists,Regulations for the Supervision and Administration of Medical D

13、evices,条例：Regulations for the Supervision and Administration of Medical Devices State council directive NO.276 2000.01.04 Release 2000.04.01 implement,12,Regulation of medical device,13,14,Technical guidances,国家食品药品监督管理局发布的医疗器械技术审评指导原则第二类纤维内窥镜产品注册技术审查指导原则第二类硬管内窥镜产品注册技术审查指导原则中频电疗产品注册技术审查指导原则B型超声诊断设备（

14、第二类）产品注册技术审查指导原则心电图机产品注册技术审查指导原则电动手术台指导原则磁疗产品注册技术审查指导原则电动病床产品注册技术审查指导原则3A类半导体激光治疗机产品注册技术审查指导原则电子血压计（示波法）产品注册技术审查指导原则红外乳腺检查仪产品注册技术审查指导原则注射泵产品注册技术审查指导原则超声理疗设备产品注册技术审查指导原则牙科综合治疗机产品注册技术审查指导原则,Medical Device Classification,The State shall classify medical devices and administer them based on this classif

15、ication Class I Medical Devices are those for which safety and effectiveness can be ensured through routine administration;Class II Medical Devices are those for which further control is required to ensure their safety and effectiveness Class III Medical Devices are those which are implanted into th

16、e human body,or used for life support or sustenance,or pose potential,15,Order NO.15 Provisions for Medical Device Classification,Article3 The Provisionsare meant to direct the formulation of The Category of Medical Device Classification as well as to determine the classes of newly registered produc

17、ts.Article 4 The classification of medical devices should be determined by a combined judgement on three respects:its structural characteristics,form of operation as well as conditions for use.Specifically,their classification can be based on Criteria for Medical Device Classification(see appendix).

18、,19,20,The Category of Medical Device C2002NO.3022002-09-05releaseAnnexThe Category of Medical Device Classification,21,Registration of MD,registration of MD refers to MD must approval by drug regulatory authority before access to market.CMDE response for evaluation of application documents（Center o

19、f MD Evaluation-CMDE）DMDR response for approval of application（Department of MD registration）Registration certification valid period is 4 years.,22,Classification registration,Article 8 The State shall implement a product registration system for the manufacturing of medical devices.Class I medical d

20、evices shall be inspected,approved and granted with a registration certificate by the drug regulatory authority of the government of the municipalities consisting of districts.Class II medical devices shall be inspected,approved and granted with registration certificates by the drug regulatory autho

21、rities of provinces,autonomous regions and municipalities directly under the central government.Class III medical devices shall be inspected,approved and granted with registration certificates by the drug regulatory authority directly under the State Council.Importing MD shall be inspected,approved

22、and granted with registration certificates by the drug regulatory authority directly under the State Council.,Provisions for Medical Device Registration,23,total 9 chapters,56Articles,12 Annexs.actually registrationorders,convenience for Applicants.add re-registration,ModifyReplacement certification

23、 12 Annexs have same legal effect.greater legal accountability efforts concisely phrase,Easy to understand.,Registration process,24,25,25,Category national standard(GB,GB/T)mandatory(GB,YY、YZB)、industrial standard(YY,YY/T)recommend(GB/T,YY/T)registration product standard(YZB)。until DEC.2012,There ar

24、e 1050 MD standards，of which national standards 180，of which mandatory standards90；industrial standards 870，of whichmandatorystandards320.,Standards of china MD,Standardized technical committee,There are 22 standardized technical committees being response for drafting and revising national and indus

25、trial standards,27,27,RPS,MD Should have RPS including national standards and industrial standards，but requirements of RPS shall not be lower than requirements of national and industrial standards.manufacturers are responsible for RPS.Chinese authority address“RPS is industrial standard,if no corresponding national or industrial standard”,Structure of RPS,ScopeNormative referencesClassification and composition requirementMethod of testing rule of testing labeling、symbol and instruction packing、transportation and storage RPS explanation,thanks！,29,