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1、State Food and Drug Administration,China,1,The Regulation of Medical Devices in China,Orient Ventures Ltd.Department of Medical Devices State Food and Drug Administration,China April 13-14,2005,State Food and Drug Administration,China,2,OVERVIEWAdministrative Organizations and RegulationsMedical Dev
2、ice StandardizationSupervision over Medical Device ManufacturingMedical Device Vigilance,State Food and Drug Administration,China,3,1.Administrative Organizations and Regulations,State Food and Drug Administration,China,4,About SFDA,State Food and Drug Administration(SFDA)founded in 2003,directly le
3、d by the State Council of P.R.China;Local Agencies:31 provincial-,433 municipality-,1,936 county-level agencies(2,401 total);Technical Organizations:16 state-,122 provincial-,373 municipality-,436 county-level organizations(947 total),State Food and Drug Administration,China,5,State Council,SFDA,Gen
4、eral Office,Dept.of Drug Registration,Dept.of Drug Market Compliance,Dept.of Drug Safety&Inspection,Dept.of Medical Devices,Dept.of Personnel&Education,Dept.of International Cooperation,Dept.of Policy&Regulation,Dept.of Food Safety Supervision,Dept.of Food Safety Coordination,Organizational Structur
5、e of SFDA,State Food and Drug Administration,China,6,Department of Medical Devices Division of Standardization Division of Product Registration Division of Safety&Supervision Department of Drug Market Compliance,State Food and Drug Administration,China,7,SFDA Technical OrganizationsMedical Device Te
6、chnical Evaluation Center;National Center for Adverse Drug Reactions Monitoring;Medical Device Quality Testing Centers;The Technical Committee for Medical Device Standardization,State Food and Drug Administration,China,8,MD Regulatory System in China,1Regulation(issued by the State Council)2.SFDA Or
7、ders3SFDA Documents,State Food and Drug Administration,China,9,MD Regulations,1Regulation Regulation for the Supervision and Administration of Medical Devices State Council Order No.276(Jan 4,2000)come into force as of April 1,2000.,State Food and Drug Administration,China,10,2.SFDA Orders(1)Provisi
8、ons on Classification of Medical Devices(No.15)(2)Provisions on Medical Device Registration(No.16)(3)Provisions on New Medical Device Approval(Interim)(No.17)(4)Provisions on Medical Device Manufacturing Supervision&Administration(No.12)(5)Provisions on Medical Device Distributor Licensure Administr
9、ation(No.15),State Food and Drug Administration,China,11,(6)Provisions on Medical Device Manufacturing Enterprise Quality System Inspection(No.22)(7)Provisions on Single Use Sterile Medical Device Supervision&Administration(Interim)(No.24)(8)Provisions on Instruction for Use and Labeling of Medical
10、Devices(No.10)(9)Provisions on Medical Device Standardization(No.31)(10)Provisions on Clinical Trial of Medical Devices(No.5),State Food and Drug Administration,China,12,3SFDA Documents(Examples)Product Classification Catalog of Medical DevicesProvisions on Cornea Contact Lens Distribution Supervisi
11、on&AdministrationDetailed rules on Single Use Sterile Medical Device(syringe,infusion)ManufacturingProvisions on the Daily Supervision for Medical Device Manufacturing Enterprises(Interim),State Food and Drug Administration,China,13,Provisions on Qualification Certification of Medical Device Testing
12、 Center(Interim)Detailed Rules on Medical Device Manufacturer Licensing Practice Detailed Rules on Class I Medical Device Registration Licensing PracticeDetailed Rules on Class II Medical Device Registration Licensing PracticeDetailed Rules on Class III&Imported Medical Device Registration Licensing
13、 Practice,State Food and Drug Administration,China,14,Medical Device Registration(presented by Mr.Chang Yongheng)Medical Device Standardization Supervision over Medical Device Manufacturing Medical Device Vigilance,State Food and Drug Administration,China,15,2.Medical Device Standardization,State Fo
14、od and Drug Administration,China,16,Current Regulations,Regulation for the Supervision and Administration of Medical Devices(State Council Order No.276)Provisions on Medical Device StandardizationProvisions on Classification of Medical DevicesProduct Classification Catalog of Medical DevicesProvisio
15、ns on Qualification Certification of Medical Device Testing Centers(Interim),State Food and Drug Administration,China,17,Medical device Definition,Any instrument,apparatus,appliance,material,or other article whether used alone or in combination,including the software necessary for its proper applica
16、tion.It does not achieve its principal action in or on the human body by means of pharmacology,immunology or metabolism,but which may be assisted in its function by such means;the use of which is to achieve the following intended objectives:1.Diagnosis,prevention,monitoring,treatment or alleviation
17、of disease;2.Diagnosis,monitoring,treatment,alleviation of or compensation for an injury or handicap conditions;3.Investigation,replacement or modification for anatomy or a physiological process;4.Control of conception.,State Food and Drug Administration,China,18,MD Classification,Class I Medical De
18、vices:safety and effectiveness can be ensured through routine administration;Class II Medical Devices:further control is required to ensure their safety and effectiveness;Class III Medical Devices:implanted into the human body,or used for life support or sustenance,or pose potential risk to the huma
19、n body and thus must be strictly controlled in respect to safety and effectiveness.,State Food and Drug Administration,China,19,Medical Device Standards Classification:Basic standard,Safety standard,Product standard;Compulsory standard(GB,YY),Recommended standard(GB/T,YY/T);National standard(GB,GB/T
20、),SFDA standard(YY,YY/T),Registration product standard(ZCB),State Food and Drug Administration,China,20,EXAMPLES GB9706.1-1995 idt IEC60601.1:1988 Medical Electrical Equipment Part 1.General requirements for safety GB/T16886-2001 idt ISO10993:1997 Biological evaluation of medical devices YY/T0316-20
21、03 idt ISO14971:2000 Medical devices-Application of risk management to medical devicesYY/T0287-2003 idt ISO13485:2003 Medical devices-Quality Management Systems-Requirements for Regulatory Purposes,State Food and Drug Administration,China,21,Formulation of National SFDA standards:68(including NEW&RE
22、VISED),Progress in Medical Device Standardization,State Food and Drug Administration,China,22,Qualification certification for testing centers 2004:27 testing centers certified;other 7 inspections completed,State Food and Drug Administration,China,23,3.Supervision over Medical Device Manufacturing,St
23、ate Food and Drug Administration,China,24,Current Regulations,Regulation for the Supervision and Administration of Medical Devices(State Council Order No.276)Provisions on Medical Device Manufacturing Supervision&AdministrationProvisions on Medical Device Manufacturing Enterprise Quality System Insp
24、ectionProvisions on the Daily Supervision for MD Manufacturing Enterprises(Interim),State Food and Drug Administration,China,25,Medical Device Manufacturing Enterprise Licensing Manufacturer of Class I II III product,State Food and Drug Administration,China,26,General Conditions for MD Enterprise Op
25、eration(1)Qualified technical staff;(2)Manufacturing location and environment;(3)Manufacturing equipment;(4)Product quality testing capability(personnel,equipment),State Food and Drug Administration,China,27,Special Requirements for Enterprises of Class II(5)Keep all related regulations and technica
26、l standards,State Food and Drug Administration,China,28,Additional Requirements for Enterprises of Class III Products(1)No less than 2 internal auditors of Quality System;(2)No less than 2 technical staff with medium-graded technical rank and above,State Food and Drug Administration,China,29,Daily S
27、upervision for Manufacturers,Provisions on the Daily Supervision for MD Manufacturing Enterprises(Interim)Key-Supervised Products and Manufacturers country level-:607(30 products)provincial level-:997,State Food and Drug Administration,China,30,Requirements for Quality System,Detailed Rules on Medic
28、al Device Manufacturer Licensing Practice Provisions on Medical Device Manufacturing Enterprise Quality System InspectionDetailed Rules on the Production of some KEY ProductsYY/T 0287 idt ISO 13485 Quality System Certification,State Food and Drug Administration,China,31,Principles on drafting GMP re
29、gulation,1Reference to the Standard YY/T0287-2003 idt ISO 13485:2003;2Integrated with the requirements in Chinese MD regulations and relevant standards；3Cover all the processes including design,production,installation,sales and service,for the Class II 4.As regulatory requirements-compulsory,State F
30、ood and Drug Administration,China,32,Framework of GMP Regulation,General rules Implementation guidelines(by category)Detailed implementation rules on product manufacturing(by product),State Food and Drug Administration,China,33,Working Progress Sterile device Implantable deviceWorking Plan,Responsib
31、ility for GMPSFDALocal agencies in provincial and below,State Food and Drug Administration,China,34,4.Medical Device Vigilance-Monitoring and Reevaluation,State Food and Drug Administration,China,35,Current Regulations,Regulation for the Supervision and Administration of Medical Devices(State Counci
32、l Order No.276)Provisions on Medical Device RegistrationProvisions on Medical Device Manufacturing Supervision&AdministrationProvisions on Medical Device Distributor Licensure AdministrationProvisions on Single Use Sterile Medical Device Supervision&Administration(Interim),State Food and Drug Admini
33、stration,China,36,Regulatory System Regulation for the Supervision and Administration of Medical Devices(State Council Order No.276)Provisions on Medical Device Registration(SFDA Order No.16),Progress in Medical Device Vigilance,State Food and Drug Administration,China,37,Provisions on Medical Devic
34、e Manufacturing Supervision&Administration(SFDA Order No.12)Provisions on Medical Device Distributor Licensure Administration(SFDA Order No.15)Provisions on Single Use Sterile Medical Device Supervision&Administration(Interim)(SDA Order No.24),State Food and Drug Administration,China,38,Technical Su
35、pporting Organizations,State Food and Drug Administration,China,39,Work Plan in 2005,Formulate“Provisions on the Reconditioned Medical Device AdministrationFormulate“Provisions on IVD(Medical Device)Registration”Formulate“Detailed Rules on the Technical Review for Specific Registration Products”(by
36、category)Revise“Provisions on Medical Device Standardization”Revise“Provisions on the Qualification Certification of Medical Device Testing Centers”,State Food and Drug Administration,China,40,Formulate“Working Procedure for Drafting the SFDA Standards”Formulate“Good Manufacturing Practices for Medi
37、cal Devices”(QSR)Formulate“Provisions on MD Adverse Events Monitoring&Reevaluation”(MDV)Formulate“Provisions on Medical Device Recall”Reinforce and improve the daily supervision,in combination with the establishment of the credibility system,State Food and Drug Administration,China,41,For more information,http:/http:/My Email:,State Food and Drug Administration,China,42,
