医疗器械法规和管理课件.ppt

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 BIMTAs 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,certifica

3、tion testing,entrusted testing and arbitration testing in and out of China.-Testing CapacityImport&ExportRegistrationSupervisionCertificationEntrustContent1.Present situation of CFDA2.Present medical device regulations system3.Present medical device standards system34 Control of all life cycleProduc

4、ts registrationManufacturer approvedSurveillance for products：such as sampling testing,Recall,Adverse events.Surveillance for behaviors(GMP):Such as quality systems,distribution,use,disposalPost marketBeforemarketMD life cycleR&DManufacture salesuseservicedisposal Present situation of CFDA5China foo

5、d and drug administrationDepartment of Medical Device RegistrationDepartment of Medical Device supervisionRegistration IRegistration IIGeneral AffairsGeneral AffairsDepartment of Science,Technology and StandardsResearch SupervisionManufacturing SupervisionDistribution SupervisionDivision of Monitori

6、ng and Re-evaluation Department of Medical Device RegistrationvTo 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 impl

7、ement classification administration,and supervise the implementation of good practices for medical devices.6 Department of Medical Device Supervision vTo track and analyze medical device safety situation and existing problems,and to put forward recommendations on system,mechanism and performance imp

8、rovement;to supervise the low-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.7Departme

9、nt of Science,Technology and StandardsTo 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 testin

10、g norms governing food and 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

11、of food safety standards.8 Technical Support institutesvCenter of Medical Device EvaluationvCenter of Medical Device Standards Management vMedical Device Standards Technical CommitteesvInstitute of Medical Device TestingvCenter of Drug Adverse Events Monitoring and Reevaluation.9 Characteristics of

12、structure reformvStrengthen post market supervisionvStress on R&D and standards10 Medical device regulation system11RegulationNormative Document GuidancesRegulations for the Supervision and Administration of Medical DevicesORDER NO.101516Order provisionlistsRegulations for the Supervision and Admini

13、stration of Medical Devicesv 条例：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 deviceordernameDate of ImplementNO.5Provision of medical device clinical trail2004-04-01NO.10Provis

14、ion of medical device instruction2004-07-08NO.12Good manufacture procedure of medical device2004-07-20NO.15Provisions for Medical Device Classification 2000-04-10NO.13Provisions for Medical Device distribution 2004-08-09NO.16Provision of medical device registrition2004-08-09NO.17Provision of new med

15、ical device approval2000-04-20NO.22Provision of Medical device quality system audit2000-07-01NO.24Provision of single use medical device supervision2000-10-13NO.31Provision of medical device standard2002-05-011314Technical 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

16、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（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 ClassificationvThe State shall classify medical

17、devices and administer them based on this classification 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 Medi

18、cal Devices are those which are implanted into the human body,or used for life support or sustenance,or pose potential 15Order NO.15 Provisions for Medical Device ClassificationvArticle3 The Provisions are meant to direct the formulation of The Category of Medical Device Classification as well as to

19、 determine the classes of newly registered products.v 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 Criter

20、ia for Medical Device Classification(see appendix).v19206801Basic surgery device6802Micro-surgery device6803Neurosurgery device。6821Electrical medical device6822Optical and endscope6823Ultrasound medical device6824Laser medical device。6832High energy ray equipment6840IVD system6841Medical laboratory

21、 device6858Medical cooling therapy and storage equipment6863Dental material。6870Medical software6877Implant deviceThe Category of Medical Device C2002NO.3022002-09-05releaseAnnexThe Category of Medical Device Classification21Registration of MDregistration of MD refers to MD must approval by drug reg

22、ulatory authority before access to market.CMDE response for evaluation of application documents （Center of MD Evaluation-CMDE）DMDR response for approval of application（Department of MD registration）Registration certification valid period is 4 years.22Classification registrationvArticle 8 The State s

23、hall implement a product registration system for the manufacturing of medical devices.vClass I medical devices shall be inspected,approved and granted with a registration certificate by the drug regulatory authority of the government of the municipalities consisting of districts.vClass II medical de

24、vices shall be inspected,approved and granted with registration certificates by the drug regulatory authorities of provinces,autonomous regions and municipalities directly under the central government.vClass III medical devices shall be inspected,approved and granted with registration certificates b

25、y the drug regulatory authority directly under the State Council.vImporting MD shall be inspected,approved and granted with registration certificates by the drug regulatory authority directly under the State Council.Provisions for Medical Device Registrationchaptercontentarticle一General provision18二

26、Registration testing of MD915三Clinical trail of MD1618四Registration application and approval1932五Re-registration3337六ModifyReplacement certification3841七supervision4245八Legal responsibility4650九Supplementary article515623 total 9 chapters,56Articles,12 Annexs.actually registrationorders,convenience

27、for Applicants.add re-registration,ModifyReplacement certification 12 Annexs have same legal effect.greater legal accountability efforts concisely phrase,Easy to understand.Registration process24R&DRPSFacility Enterprise License Type testingClinicaltrailQuality system auditCollectionmaterialsRegistr

28、ation2525Category 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 are 1050 MD standards，of which national standards 180，of which mandatory standards90；industrial standards 870，of whichmandatorystan

29、dards320.Standards of china MDStandardized technical committeenumbernumbernamenamesecretariat1TC 136IVDBIMT2TC 10/SC1X ray equipmentLiaoning3TC 10/SC3Radiotherapy&nuclearBIMT4TC 10/SC2Ultrasound equipmentHubei5TC 10/SC4 Physical therapyTianjin6TC 10/SC5Electrical medical deviceshanghai7TC 94Surgery

30、deviceshanghai8There are 22 standardized technical committees being response for drafting and revising national and industrial standards2727 RPS MD Should have RPS including national standards and industrial standards，but requirements of RPS shall not be lower than requirements of national and indus

31、trial standards.manufacturers are responsible for RPS.Chinese authority address“RPS is industrial standard,if no corresponding national or industrial standard”Structure of RPS1.Scope2.Normative references3.Classification and composition4.requirement5.Method of testing6.rule of testing7.labeling、symbol and instruction 8.packing、transportation and storage 9.RPS explanationthanks！29