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

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. OVERVIEW
Administrative Organizations and
Regulations
Medical Device Standardization
Supervision over Medical Device
Manufacturing
Medical Device Vigilance
State Food and Drug Administration,China 2

3. 1. Administrative Organizations
and Regulations
State Food and Drug Administration,China 3

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. 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. 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. 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. 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. 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. 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. (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. 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. 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. 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. 2. Medical Device Standardization
State Food and Drug Administration,China 15

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. 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. 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. 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. 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. 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. • Qualification certification for testing centers
2004: 27 testing centers certified;
other 7 inspections completed
State Food and Drug Administration,China 22

23. 3. Supervision over Medical
Device Manufacturing
State Food and Drug Administration,China 23

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 4. Medical Device Vigilance
----Monitoring and Reevaluation
State Food and Drug Administration,China 34

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. 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. 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. • Technical Supporting Organizations
State Food and Drug Administration,China 38

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. 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. • 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. 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. 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. Examples
Polyacrylamide Hydrogel
Cornea Contact Lens (OK Lens)
State Food and Drug Administration,China 44

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. 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. 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. 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. 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. Main Contents
Re-evaluation of Product
Manufacturers
Regulatory Agencies and
their Technical Organizations
State Food and Drug Administration,China 50

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. 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. 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. 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. State Food and Drug Administration,China 55