State Food and Drug Administration,China1 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,China2 OVERVIEW Administrative Organizations and Regulations Medical Device Standardization Supervision over Medical Device Manufacturing Medical Device Vigilance

State Food and Drug Administration,China3 1. Administrative Organizations and Regulations

State Food and Drug Administration,China4 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,China5 State Council SFDA Gener al Office Dept. of Drug Registr ation Dept. of Drug Market Complia nce Dept. of Drug Safety &Inspe ction Dept. of Medical Devices Dept. of Personn el & Educatio n Dept. of Internati onal Coopera tion Dept. ofPolicy &Regulation Dept. ofFoodSafetySupervisionDept. ofFoodSafetyCoordination Organizational Structure of SFDA

State Food and Drug Administration,China6 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,China7 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,China8 MD Regulatory System in China 1 Regulation (issued by the State Council) 2. SFDA Orders 3 SFDA Documents

State Food and Drug Administration,China9 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,China10 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,China11 (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,China12 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,China13 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,China14 Medical Device Registration (presented by Mr. Chang Yongheng) Medical Device Standardization Supervision over Medical Device Manufacturing Medical Device Vigilance

State Food and Drug Administration,China15 2. Medical Device Standardization

State Food and Drug Administration,China16 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,China17 "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.

State Food and Drug Administration,China18 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,China19 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,China20 EXAMPLES GB idt IEC :1988 Medical Electrical Equipment Part 1. General requirements for safety GB/T idt ISO10993:1997 Biological evaluation of medical devices YY/T idt ISO14971:2000 Medical devices-Application of risk management to medical devices YY/T idt ISO13485:2003 Medical devices-Quality Management Systems-Requirements for Regulatory Purposes

State Food and Drug Administration,China21 Formulation of National & SFDA standards national standards: 134; SFDA standards: : national standards: 23; SFDA standards: 68 (including NEW & REVISED) Progress in Medical Device Standardization

State Food and Drug Administration,China22 Qualification certification for testing centers 2004: 27 testing centers certified; other 7 inspections completed

State Food and Drug Administration,China23 3. Supervision over Medical Device Manufacturing

State Food and Drug Administration,China24 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,China25 Medical Device Manufacturing Enterprise Licensing & Informing Manufacturer of Class II, III product; Manufacturer of Class I II III product

State Food and Drug Administration,China26 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,China27 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,China28 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,China29 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,China30 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 Quality System Certification

State Food and Drug Administration,China31 Principles on drafting GMP regulation 1 Reference to the Standard YY/T 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,China32 Framework of GMP Regulation General rules Implementation guidelines (by category) Detailed implementation rules on product manufacturing (by product)

State Food and Drug Administration,China33 Working Progress Sterile device Implantable device Working Plan Responsibility for GMP SFDA Local agencies in provincial and below

State Food and Drug Administration,China34 4. Medical Device Vigilance ----Monitoring and Reevaluation

State Food and Drug Administration,China35 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,China36 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,China37 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,China38 Technical Supporting Organizations

State Food and Drug Administration,China39 Time: Dec 1, 2002 to June 30, 2004 Medical Devices: Cardiovascular stent; Cornea contact len (Orthokeratology len); Cardiac value; Polyacrylamide hydrogel; Orthopaedic implant Pilot Program ( )

State Food and Drug Administration,China40 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,China41 Adverse Events Reporting ( ) until December 31, 2004 suspected case-reports: 817 (451 in 2004); summary reports from manufacturer: 241 (143 in 2004)

State Food and Drug Administration,China42 Manufacturers, distributors, user facilities Provincial Center for MD Adverse Events monitoring National Center for ADR Monitoring Serious injury, 10 days Serious injury, 10 days Death, at once Suspect Adverse Events Case Report

State Food and Drug Administration,China43 Manufacturers Provincial Center for MD Adverse Events Monitoring National Center for ADR Monitoring 20 days Quarterly Summary Report for Manufacturers

State Food and Drug Administration,China44 Examples Polyacrylamide Hydrogel Cornea Contact Lens (OK Lens)

State Food and Drug Administration,China45 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,China46 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,China47 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,China48 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,China49 ManufacturerDistributorUser Facility Provincial Technical Center for Medical Device Adverse Events Monitoring National Center for Adverse Drug Reactions Monitoring SFDA MOH IR-5,15d FR-20d SR-each yr (Class, ) IR-5,15d FR-15d SR-30d PSR

State Food and Drug Administration,China50 Main Contents Re-evaluation of Product Manufacturers Regulatory Agencies and their Technical Organizations

State Food and Drug Administration,China51 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,China52 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,China53 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,China54 For more information My

State Food and Drug Administration,China55