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The Regulation Of Medical Device In China
 

The Regulation Of Medical Device In China

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Author:Wang Lanming

Author:Wang Lanming
Department of Medical Devices
SFDA, hina
April 13-14, 2005 in Washington & Boston, U.S.A

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    The Regulation Of Medical Device In China The Regulation Of Medical Device In China Presentation Transcript

    • The Regulation of Medical Devices in China Wang Lanming Department of Medical Devices State Food and Drug Administration, China April 13-14, 2005 in Washington & Boston, U.S.A State Food and Drug Administration,China 1
    • OVERVIEW Administrative Organizations and Regulations Medical Device Standardization Supervision over Medical Device Manufacturing Medical Device Vigilance State Food and Drug Administration,China 2
    • 1. Administrative Organizations and Regulations State Food and Drug Administration,China 3
    • About SFDA State Food and Drug Administration (SFDA) founded in 2003, directly led 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 4
    • Organizational Structure of SFDA State Council SFDA Dept. of Dept. of Dept. of Dept. Dept. Dept. of Dept. of Dept. of Gene Policy & Food Food of Drug Dept. of of Drug Drug Personn Internati ral Regulati Safety Safety Registr Medical Safety Market el & onal Office on Coordina Supervisi ation Devices &Inspe Complia Educati Coopera tion on ction nce on tion State Food and Drug Administration,China 5
    • Department of Medical Devices ① Division of Standardization ② Division of Product Registration ③ Division of Safety & Supervision Department of Drug Market Compliance State Food and Drug Administration,China 6
    • SFDA Technical Organizations Medical Device Technical 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 7
    • MD Regulatory System in China 1.Regulation (issued by the State Council) 2. SFDA Orders 3.SFDA Documents State Food and Drug Administration,China 8
    • MD Regulations 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. State Food and Drug Administration,China 9
    • 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) State Food and Drug Administration,China 10
    • (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) State Food and Drug Administration,China 11
    • 3.SFDA Documents (Examples) Product Classification Catalog of Medical Devices Provisions on Cornea Contact Lens Distribution Supervision & Administration Detailed rules on Single Use Sterile Medical Device (syringe, infusion) Manufacturing Provisions on the Daily Supervision for Medical Device Manufacturing Enterprises (Interim) State Food and Drug Administration,China 12
    • Provisions on Qualification Certification of Medical Device Testing Center (Interim) Detailed Rules on Medical Device Manufacturer Licensing Practice Detailed Rules on Class I Medical Device Registration Licensing Practice Detailed Rules on Class II Medical Device Registration Licensing Practice Detailed Rules on Class III & Imported Medical Device Registration Licensing Practice ……… State Food and Drug Administration,China 13
    • 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 14
    • 2. Medical Device Standardization State Food and Drug Administration,China 15
    • Current Regulations Regulation for the Supervision and Administration of Medical Devices (State Council Order No. 276) Provisions on Medical Device Standardization Provisions on Classification of Medical Devices Product Classification Catalog of Medical Devices Provisions on Qualification Certification of Medical Device Testing Centers (Interim) ……… State Food and Drug Administration,China 16
    • quot;Medical devicequot; 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. State Food and Drug Administration,China 17
    • MD Classification Class I Medical Devices: 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 human body and thus must be strictly controlled in respect to safety and effectiveness. State Food and Drug Administration,China 18
    • 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), SFDA standard (YY, YY/T), Registration product standard (ZCB) State Food and Drug Administration,China 19
    • 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/T0316-2003 idt ISO14971:2000 Medical devices-Application of risk management to medical devices YY/T0287-2003 idt ISO13485:2003 Medical devices-Quality Management Systems-Requirements for Regulatory Purposes State Food and Drug Administration,China 20
    • Progress in Medical Device Standardization • Formulation of National & SFDA standards national standards: 134; SFDA standards: 560 2004: national standards: 23; SFDA standards: 68 (including NEW & REVISED) State Food and Drug Administration,China 21
    • • Qualification certification for testing centers 2004: 27 testing centers certified; other 7 inspections completed State Food and Drug Administration,China 22
    • 3. Supervision over Medical Device Manufacturing State Food and Drug Administration,China 23
    • Current Regulations Regulation for the Supervision and Administration of Medical Devices (State Council Order No.276) Provisions on Medical Device Manufacturing Supervision & Administration Provisions on Medical Device Manufacturing Enterprise Quality System Inspection Provisions on the Daily Supervision for MD Manufacturing Enterprises (Interim) ……… State Food and Drug Administration,China 24
    • Medical Device Manufacturing Enterprise Licensing & Informing Manufacturer of Class II, III product; Manufacturer of Class I II III product State Food and Drug Administration,China 25
    • 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) State Food and Drug Administration,China 26
    • 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 standards State Food and Drug Administration,China 27
    • 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 28
    • Daily Supervision 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 29
    • Requirements for Quality System Detailed Rules on Medical Device Manufacturer Licensing Practice Provisions on Medical Device Manufacturing Enterprise Quality System Inspection Detailed Rules on the Production of some KEY Products YY/T 0287 idt ISO 13485 Quality System Certification State Food and Drug Administration,China 30
    • Principles on drafting GMP regulation 1.Reference to the Standard YY/T0287- 2003 idt ISO 13485: 2003; 2.Integrated with the requirements in Chinese MD regulations and relevant standards; 3.Cover all the processes including design, production, installation, sales and service, for the Class II & III manufacturer; 4. As regulatory requirements --- compulsory State Food and Drug Administration,China 31
    • Framework of GMP Regulation General rules Implementation guidelines (by category) Detailed implementation rules on product manufacturing (by product) State Food and Drug Administration,China 32
    • Responsibility for GMP SFDA Local agencies in provincial and below Working Progress ◊ Sterile device ◊ Implantable device Working Plan State Food and Drug Administration,China 33
    • 4. Medical Device Vigilance ----Monitoring and Reevaluation State Food and Drug Administration,China 34
    • Current Regulations Regulation for the Supervision and Administration of Medical Devices (State Council Order No. 276) Provisions on Medical Device Registration Provisions on Medical Device Manufacturing Supervision & Administration Provisions on Medical Device Distributor Licensure Administration Provisions on Single Use Sterile Medical Device Supervision & Administration (Interim) ……… State Food and Drug Administration,China 35
    • Progress in Medical Device Vigilance 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) State Food and Drug Administration,China 36
    • 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) State Food and Drug Administration,China 37
    • • Technical Supporting Organizations State Food and Drug Administration,China 38
    • • Pilot Program (2002.12-2004.06) Time: Dec 1, 2002 to June 30, 2004 Medical Devices: Cardiovascular stent; Cornea contact len (Orthokeratology len); Cardiac value; Polyacrylamide hydrogel; Orthopaedic implant State Food and Drug Administration,China 39
    • Participants: Beijing, Shanghai, Guangdong province plus other 5 hospitals and 8 manufactures Totally:50 manufactures; 232 distributors; 268 hospitals were involved State Food and Drug Administration,China 40
    • • Adverse Events Reporting (2004.07- ) until December 31, 2004 suspected case-reports: 817 (451 in 2004); summary reports from manufacturer: 241 (143 in 2004) State Food and Drug Administration,China 41
    • Suspect Adverse Events Case Report National Center for ADR Monitoring Serious injury, Death, at once 10 days Provincial Center for MD Adverse Events monitoring Serious injury, Death, at once 10 days Manufacturers, distributors, user facilities State Food and Drug Administration,China 42
    • Summary Report for Manufacturers National Center for ADR Monitoring 20 days Provincial Center for MD Adverse Events Monitoring Quarterly Manufacturers State Food and Drug Administration,China 43
    • Examples Polyacrylamide Hydrogel Cornea Contact Lens (OK Lens) State Food and Drug Administration,China 44
    • Principle on the establishment of MDV system Go around one destination Pay attention to two points for reference Establish three systems Practice four integrations State Food and Drug Administration,China 45
    • Provisions on the Adverse Events Monitoring and Re-evaluation of Medical Devices (Draft) 7 chapters, 41 Articles Chapter 1 General Provisions Chapter 2 Organizations and Responsibility Chapter 3 Reporting and Assessment Chapter 4 Re-evaluation of the Product Chapter 5 Control of Serious Events Chapter 6 Penalties Chapter 7 Supplementary Provisions State Food and Drug Administration,China 46
    • Main Contents Issued by SFDA & MOH Definitions adverse event, reportable adverse event, adverse event monitoring, re- evaluation Organizations and Responsibility State Food and Drug Administration,China 47
    • Main Contents Reporting and Assessment of Adverse Events Initial Report --- for manufacturer, distributor and user facility; Follow Report --- for manufacturer; Summary Report --- only for manufacturer of Class II & III products State Food and Drug Administration,China 48
    • Manufacturer Distributor User Facility IR-5,15d FR-20d IR-5,15d IR-5,15d SR-each yr (ClassⅡ,Ⅲ) Provincial Technical Center for Medical Device Adverse Events IR-5,15d Monitoring FR-15d SR-30d National Center for Adverse Drug Reactions Monitoring PSR PSR SFDA MOH State Food and Drug Administration,China 49
    • Main Contents Re-evaluation of Product Manufacturers Regulatory Agencies and their Technical Organizations State Food and Drug Administration,China 50
    • Main Contents Control of Serious Adverse Events Distributor, User Facility Manufacturer Regulatory Agency Penalties Manufacturer, Distributor, User Facility Medical Institution (Hospital, Clinic etc) State Food and Drug Administration,China 51
    • Work Plan in 2005 Formulate “Provisions on the Reconditioned Medical Device Administration Formulate “Provisions on IVD (Medical Device) Registration” Formulate “Detailed Rules on the Technical Review for Specific Registration Products ” (by category) Revise “Provisions on Medical Device Standardization” Revise “Provisions on the Qualification Certification of Medical Device Testing Centers” State Food and Drug Administration,China 52
    • Formulate “Working Procedure for Drafting the SFDA Standards” Formulate “Good Manufacturing Practices for Medical 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 53
    • For more information http://www.sfda.gov.cn http://www.cmdi.gov.cn My Email: sfdawlm@126.com wlanming@sina.com State Food and Drug Administration,China 54
    • State Food and Drug Administration,China 55