china medical device regulations.ppt

The Regulation of Medical Devices in ChinaOrient Ventures Ltd. Department of Medical DevicesDepartment of Medical Devices State Food and Drug Administration, China State Food and Drug Administration, China April 13-14, 2005 1State Food and Drug Administration,ChinaOVERVIEWlAdministrative Organizations and RegulationslMedical Device StandardizationlSupervision over Medical Device ManufacturinglMedical Device Vigilance2State Food and Drug Administration,China1. Administrative Organizations and Regulations3State Food and Drug Administration,ChinaAbout SFDAlState Food and Drug Administration (SFDA) founded in 2003, directly led by the State Council of P. R. China;lLocal Agencies: 31 provincial-, 433 municipality-,1,936 county- level agencies (2,401 total);lTechnical Organizations: 16 state-, 122 provincial-, 373 municipality-, 436 county- level organizations (947 total)4State Food and Drug Administration,ChinaState Council SFDA General OfficeDept. of Drug RegistrationDept. of Drug Market ComplianceDept. of Drug Safety &InspectionDept. of Medical DevicesDept. of Personnel & EducationDept. of International CooperationDept. of Policy & RegulationDept. of Food Safety SupervisionDept. of Food Safety CoordinationOrganizational Structure of SFDA5State Food and Drug Administration,ChinalDepartment of Medical Devices ① Division of Standardization ② Division of Product Registration 　 ③ Division of Safety & Supervision 　 lDepartment of Drug Market Compliance6State Food and Drug Administration,ChinaSFDA Technical OrganizationslMedical Device Technical Evaluation Center; lNational Center for Adverse Drug Reactions Monitoring;lMedical Device Quality Testing Centers;lThe Technical Committee for Medical Device Standardization7State Food and Drug Administration,ChinaMD Regulatory System in China1．Regulation (issued by the State Council)2. SFDA Orders3．SFDA Documents8State Food and Drug Administration,China MD Regulations1 1．．Regulation 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. 9State Food and Drug Administration,China2. SFDA Orders (1) Provisions 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 Administration (No.15)10State Food and Drug Administration,China(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 Devices (No.10)(9) Provisions on Medical Device Standardization (No.31)(10) Provisions on Clinical Trial of Medical Devices (No.5)11State Food and Drug Administration,China 3．．SFDA Documents (Examples)　　　　lProduct Classification Catalog of Medical DeviceslProvisions on Cornea Contact Lens Distribution Supervision & AdministrationlDetailed rules on Single Use Sterile Medical Device (syringe, infusion) ManufacturinglProvisions on the Daily Supervision for Medical Device Manufacturing Enterprises (Interim) 12State Food and Drug Administration,ChinalProvisions on Qualification Certification of Medical Device Testing Center (Interim)lDetailed Rules on Medical Device Manufacturer Licensing Practice lDetailed Rules on Class I Medical Device Registration Licensing PracticelDetailed Rules on Class II Medical Device Registration Licensing PracticelDetailed Rules on Class III & Imported Medical Device Registration Licensing Practice ………13State Food and Drug Administration,ChinalMedical Device Registration (presented by Mr. Chang Yongheng) lMedical Device Standardization lSupervision over Medical Device Manufacturing lMedical Device Vigilance14State Food and Drug Administration,China2. Medical Device Standardization15State Food and Drug Administration,ChinaCurrent RegulationslRegulation for the Supervision and Administration of Medical Devices (State Council Order No. 276)lProvisions on Medical Device StandardizationlProvisions on Classification of Medical DeviceslProduct Classification Catalog of Medical DeviceslProvisions on Qualification Certification of Medical Device Testing Centers (Interim) ………16State Food and Drug Administration,China"Medical device" Definition Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application. 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 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. 17State Food and Drug Administration,ChinaMD Classificationl Class I Medical Devices: safety and effectiveness can be ensured through routine administration; lClass II Medical Devices: further control is required to ensure their safety and effectiveness; lClass III Medical Devices: implanted into the human body, or used for life support or sustenance, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness. 18State Food and Drug Administration,China Medical Device Standards Classification: lBasic standard, Safety standard, Product standard;lCompulsory standard (GB, YY) , Recommended standard (GB/T, YY/T);lNational standard (GB, GB/T), SFDA standard (YY, YY/T), Registration product standard (ZCB)19State Food and Drug Administration,China EXAMPLESl GB9706.1-1995 idt IEC60601.1:1988 Medical Electrical Equipment Part 1. General requirements for safety lGB/T16886-2001 idt ISO10993:1997 Biological evaluation of medical devices lYY/T0316-2003 idt ISO14971:2000 Medical devices-Application of risk management to medical deviceslYY/T0287-2003 idt ISO13485:2003 Medical devices-Quality Management Systems-Requirements for Regulatory Purposes20State Food and Drug Administration,China• Formulation of National & SFDA standards national standards: 134; SFDA standards: 560 2004: national standards: 23; SFDA standards: 68 (including NEW & REVISED)Progress in Medical Device Standardization21State Food and Drug Administration,China• Qualification certification for testing centers 2004: 27 testing centers certified; other 7 inspections completed22State Food and Drug Administration,China3. Supervision over Medical Device Manufacturing23State Food and Drug Administration,ChinaCurrent RegulationslRegulation for the Supervision and Administration of Medical Devices (State Council Order No.276)lProvisions on Medical Device Manufacturing Supervision & AdministrationlProvisions on Medical Device Manufacturing Enterprise Quality System InspectionlProvisions on the Daily Supervision for MD Manufacturing Enterprises (Interim) ………24State Food and Drug Administration,ChinaMedical Device Manufacturing Enterprise Licensing & Informing Manufacturer of Class II, III product; Manufacturer of Class I II III product 25State Food and Drug Administration,China General Conditions for MD Enterprise Operation (1) Qualified technical staff; (2) Manufacturing location and environment; (3) Manufacturing equipment; (4) Product quality testing capability (personnel, equipment) 26State Food and Drug Administration,China Special Requirements for Enterprises of Class II & III Products (1) Qualification of the heads responsible for production, quality and technology; (2) Percentage of the technical staff in the all employees; (3) Suitable production equipments, locations & environments for production and storage; (4) Suitable quality testing laboratory and capability; (5) Keep all related regulations and technical standards27State Food and Drug Administration,China 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 above28State Food and Drug Administration,ChinaDaily Supervision for ManufacturerslProvisions on the Daily Supervision for MD Manufacturing Enterprises (Interim) lKey-Supervised Products and Manufacturers country level-: 607 (30 products) provincial level-: 99729State Food and Drug Administration,ChinaRequirements for Quality System lDetailed Rules on Medical Device Manufacturer Licensing Practice lProvisions on Medical Device Manufacturing Enterprise Quality System InspectionlDetailed Rules on the Production of some KEY ProductslYY/T 0287 idt ISO 13485 Quality System Certification30State Food and Drug Administration,ChinaPrinciples on drafting GMP regulationl1．Reference to the Standard YY/T0287- 2003 idt ISO 13485: 2003;l2．Integrated with the requirements in Chinese MD regulations and relevant standards；l3．Cover all the processes including design, production, installation, sales and service, for the Class II & III manufacturer;l4. As regulatory requirements --- compulsory31State Food and Drug Administration,ChinaFramework of GMP RegulationlGeneral rules l Implementation guidelines (by category) l Detailed implementation rules on product manufacturing (by product)32State Food and Drug Administration,ChinaWorking Progress◊ Sterile device◊ Implantable deviceWorking PlanResponsibility for GMPlSFDAlLocal agencies in provincial and below33State Food and Drug Administration,China4. Medical Device Vigilance----Monitoring and Reevaluation34State Food and Drug Administration,ChinaCurrent RegulationslRegulation for the Supervision and Administration of Medical Devices (State Council Order No. 276)lProvisions on Medical Device RegistrationlProvisions on Medical Device Manufacturing Supervision & AdministrationlProvisions on Medical Device Distributor Licensure AdministrationlProvisions on Single Use Sterile Medical Device Supervision & Administration (Interim) ………35State Food and Drug Administration,ChinalRegulatory 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 Vigilance36State Food and Drug Administration,ChinaProvisions on Medical Device 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)37State Food and Drug Administration,China• Technical Supporting Organizations38State Food and Drug Administration,ChinaWork Plan in 2005lFormulate “Provisions on the Reconditioned Medical Device AdministrationlFormulate “Provisions on IVD (Medical Device) Registration” lFormulate “Detailed Rules on the Technical Review for Specific Registration Products ” (by category)lRevise “Provisions on Medical Device Standardization”lRevise “Provisions on the Qualification Certification of Medical Device Testing Centers”39State Food and Drug Administration,ChinalFormulate “Working Procedure for Drafting the SFDA Standards”lFormulate “Good Manufacturing Practices for Medical Devices” (QSR) lFormulate “Provisions on MD Adverse Events Monitoring & Reevaluation” (MDV) lFormulate “Provisions on Medical Device Recall”lReinforce and improve the daily supervision, in combination with the establishment of the credibility system40State Food and Drug Administration,China For more informationl llMy Email:info@41State Food and Drug Administration,China42State Food and Drug Administration,China。