The Regulation of Medical
      Devices in China

             Wang Lanming
       Department of Medical Devices
State Foo...
OVERVIEW

 Administrative Organizations and
 Regulations
 Medical Device Standardization
 Supervision over Medical Device
...
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;
Lo...
Organizational Structure of SFDA

                                              State Council


                          ...
Department of Medical Devices
  ① Division of Standardization
 ② Division of Product Registration
 ③ Division of Safety & ...
SFDA Technical Organizations
 Medical Device Technical Evaluation Center;
 National Center for Adverse Drug Reactions
 Mon...
MD Regulatory System in China

 1.Regulation (issued by the State
   Council)
 2. SFDA Orders
 3.SFDA Documents



       ...
MD Regulations


 1.Regulation
  Regulation for the Supervision and
  Administration of Medical Devices
    State Council ...
2. SFDA Orders
(1) Provisions on Classification of Medical Devices (No.15)

(2) Provisions on Medical Device Registration ...
(6) Provisions on Medical Device Manufacturing Enterprise Quality
   System Inspection (No.22)

(7) Provisions on Single U...
3.SFDA Documents (Examples)
Product Classification Catalog of Medical Devices

Provisions on Cornea Contact Lens Distribut...
Provisions on Qualification Certification of Medical Device Testing
Center (Interim)

Detailed Rules on Medical Device Man...
Medical Device Registration

       (presented by Mr. Chang Yongheng)

Medical Device Standardization

Supervision over Me...
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)

P...
quot;Medical devicequot; Definition
       Any instrument, apparatus, appliance, material, or other
  article whether used...
MD Classification

 Class I Medical Devices: safety and effectiveness can
 be ensured through routine administration;
 Cla...
Medical Device Standards

Classification:
   Basic standard, Safety standard, Product standard;

   Compulsory standard (G...
EXAMPLES
 GB9706.1-1995 idt IEC60601.1:1988

 Medical Electrical Equipment Part 1. General requirements for safety

GB/T16...
Progress in Medical Device Standardization


• Formulation of National & SFDA standards
       national standards: 134;
  ...
• Qualification certification for testing centers


  2004: 27 testing centers certified;

        other 7 inspections com...
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)

Pro...
Medical Device Manufacturing
Enterprise Licensing & Informing
  Manufacturer of Class II, III product;

  Manufacturer of ...
General Conditions for MD Enterprise
Operation
  (1) Qualified technical staff;
  (2) Manufacturing location and environme...
Special Requirements for Enterprises of
Class II & III Products
(1) Qualification of the heads responsible for production,...
Additional Requirements for
Enterprises of Class III Products
 (1) No less than 2 internal auditors of Quality System;
 (2...
Daily Supervision for Manufacturers


 Provisions on the Daily Supervision for MD
 Manufacturing Enterprises (Interim)
 Ke...
Requirements for Quality System

 Detailed Rules on Medical Device Manufacturer

 Licensing Practice

 Provisions on Medic...
Principles on drafting GMP regulation

 1.Reference to the Standard YY/T0287- 2003 idt
 ISO 13485: 2003;
 2.Integrated wit...
Framework of GMP Regulation

  General rules

  Implementation guidelines (by category)

  Detailed implementation rules o...
Responsibility for GMP
 SFDA
 Local agencies in provincial and below

Working Progress
◊ Sterile device
◊ Implantable devi...
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)
Pro...
Progress in Medical Device Vigilance

  Regulatory System

Regulation for the Supervision and Administration of Medical
  ...
Provisions on Medical Device Manufacturing Supervision &
Administration (SFDA Order No.12)


Provisions on Medical Device ...
• 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;
     ...
Participants: Beijing, Shanghai, Guangdong province
            plus other 5 hospitals and 8 manufactures
    Totally:50 m...
• Adverse Events Reporting (2004.07- )

until December 31, 2004

 suspected case-reports: 817 (451 in 2004);

 summary rep...
Suspect Adverse Events Case Report


     National Center for ADR Monitoring

          Serious injury,
                  ...
Summary Report for Manufacturers



       National Center for ADR Monitoring

                 20 days


    Provincial C...
Examples


 Polyacrylamide Hydrogel

 Cornea Contact Lens (OK Lens)




            State Food and Drug Administration,Chi...
Principle on the establishment of
MDV system

      Go around one destination

 Pay attention to   two points for referenc...
Provisions on the Adverse Events
Monitoring and Re-evaluation of
Medical Devices (Draft)

     7 chapters, 41 Articles
 Ch...
Main Contents

  Issued by
       SFDA & MOH
  Definitions
      adverse event, reportable adverse
  event, adverse event ...
Main Contents

 Reporting and Assessment of Adverse
 Events
 Initial Report --- for manufacturer, distributor
 and user fa...
Manufacturer       Distributor                     User Facility
IR-5,15d
FR-20d                  IR-5,15d                ...
Main Contents


 Re-evaluation of Product
  Manufacturers
  Regulatory Agencies and
      their Technical Organizations


...
Main Contents
  Control of Serious Adverse Events
   Distributor, User Facility
   Manufacturer
   Regulatory Agency

  Pe...
Work Plan in 2005
Formulate “Provisions on the Reconditioned Medical Device

Administration

Formulate “Provisions on IVD ...
Formulate “Working Procedure for Drafting the SFDA Standards”

Formulate “Good Manufacturing Practices for Medical Devices...
For more information

  http://www.sfda.gov.cn
  http://www.cmdi.gov.cn

  My Email: sfdawlm@126.com
            wlanming@...
State Food and Drug Administration,China   55
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The Regulation Of Medical Device In China

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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

  1. 1. 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
  2. 2. OVERVIEW Administrative Organizations and Regulations Medical Device Standardization Supervision over Medical Device Manufacturing Medical Device Vigilance State Food and Drug Administration,China 2
  3. 3. 1. Administrative Organizations and Regulations State Food and Drug Administration,China 3
  4. 4. 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
  5. 5. 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
  6. 6. 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
  7. 7. 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
  8. 8. 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
  9. 9. 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
  10. 10. 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
  11. 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 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
  12. 12. 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
  13. 13. 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
  14. 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 14
  15. 15. 2. Medical Device Standardization State Food and Drug Administration,China 15
  16. 16. 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
  17. 17. 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
  18. 18. 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
  19. 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), SFDA standard (YY, YY/T), Registration product standard (ZCB) State Food and Drug Administration,China 19
  20. 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/T0316-2003 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
  21. 21. 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
  22. 22. • Qualification certification for testing centers 2004: 27 testing centers certified; other 7 inspections completed State Food and Drug Administration,China 22
  23. 23. 3. Supervision over Medical Device Manufacturing State Food and Drug Administration,China 23
  24. 24. 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
  25. 25. 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
  26. 26. 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
  27. 27. 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
  28. 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 28
  29. 29. 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
  30. 30. 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
  31. 31. 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
  32. 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 32
  33. 33. 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
  34. 34. 4. Medical Device Vigilance ----Monitoring and Reevaluation State Food and Drug Administration,China 34
  35. 35. 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
  36. 36. 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
  37. 37. 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
  38. 38. • Technical Supporting Organizations State Food and Drug Administration,China 38
  39. 39. • 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
  40. 40. 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
  41. 41. • 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
  42. 42. 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
  43. 43. 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
  44. 44. Examples Polyacrylamide Hydrogel Cornea Contact Lens (OK Lens) State Food and Drug Administration,China 44
  45. 45. 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
  46. 46. 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
  47. 47. 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
  48. 48. 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
  49. 49. 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
  50. 50. Main Contents Re-evaluation of Product Manufacturers Regulatory Agencies and their Technical Organizations State Food and Drug Administration,China 50
  51. 51. 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
  52. 52. 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
  53. 53. 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
  54. 54. 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
  55. 55. State Food and Drug Administration,China 55
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