The Regulation of Medical Devices in China

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

2

• OVERVIEW
• Administrative Organizations and Regulations
• Medical Device Standardization
• Supervision over Medical Device Manufacturing
• Medical Device Vigilance

3

• 1. Administrative Organizations and Regulations

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)

5
Organizational Structure of SFDA
State Council
SFDA
General Office
Dept. of Drug Registration
Dept. of Drug Market Compliance
Dept. of Drug Safety Inspection
Dept. of Medical Devices
Dept. of Personnel Education
Dept. of International Cooperation
Dept. of Policy Regulation
Dept. of Food Safety Supervision
Dept. of Food Safety Coordination
6

• Department of Medical Devices
• ? Division of Standardization
• ? Division of Product Registration
• ? Division of Safety Supervision
  
• Department of Drug Market Compliance

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

8
MD Regulatory System in China

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

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.

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)

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• (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)

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)

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

14

• Medical Device Registration
• (presented by Mr. Chang Yongheng)
  
• Medical Device Standardization
• Supervision over Medical Device Manufacturing
• Medical Device Vigilance

15

• 2. Medical Device Standardization

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)

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"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.

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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.

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• 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)

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• EXAMPLES
• GB9706.1-1995 idt IEC60601.11988
• Medical Electrical Equipment Part 1.
  General requirements for safety
• GB/T16886-2001 idt ISO109931997
• Biological evaluation of medical devices
• YY/T0316-2003 idt ISO149712000
• Medical devices-Application of risk
  management to medical devices
• YY/T0287-2003 idt ISO134852003
• Medical devices-Quality Management
  Systems-Requirements for Regulatory Purposes

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)

22

• Qualification certification for testing centers
• 2004 27 testing centers certified
• other 7 inspections completed

23

• 3. Supervision over Medical Device Manufacturing

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)

25
Medical Device Manufacturing Enterprise
Licensing Informing Manufacturer of Class
II, III product Manufacturer of Class I II
III product
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)
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• 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

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

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

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

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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

32
Framework of GMP Regulation

• General rules
• Implementation guidelines (by category)
• Detailed implementation rules on product
  manufacturing (by product)

33
Working Progress? Sterile device? Implantable
deviceWorking Plan

• Responsibility for GMP
• SFDA
• Local agencies in provincial and below

34

• 4. Medical Device Vigilance
• ----Monitoring and Reevaluation

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)

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)

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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)
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• Technical Supporting Organizations

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• 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

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Participants Beijing, Shanghai, Guangdong
province plus other 5
hospitals and 8 manufactures Totally50
manufactures 232 distributors
268 hospitals were involved
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)
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Suspect Adverse Events Case Report
National Center for ADR Monitoring
Serious injury, 10 days
Death, at once
Provincial Center for MD Adverse Events
monitoring
Serious injury, 10 days
Death, at once
Manufacturers, distributors, user facilities
43
Summary Report for Manufacturers
National Center for ADR Monitoring
20 days
Provincial Center for MD Adverse Events Monitoring
Quarterly
Manufacturers
44
Examples

• Polyacrylamide Hydrogel
• Cornea Contact Lens (OK Lens)

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

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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

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Main Contents

• Issued by
• SFDA MOH
• Definitions
• adverse event, reportable adverse event,
  adverse event monitoring, re-evaluation
• Organizations and Responsibility

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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

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Manufacturer
Distributor
User Facility
IR-5,15d FR-20d SR-each yr (Class?,?)
IR-5,15d
IR-5,15d
Provincial Technical Center for Medical Device
Adverse Events Monitoring
IR-5,15d FR-15d SR-30d
National Center for Adverse Drug Reactions
Monitoring
PSR
PSR
MOH
SFDA
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Main Contents

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

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Main Contents

• Control of Serious Adverse Events
• Distributor, User Facility
• Manufacturer
• Regulatory Agency
• Penalties
• Manufacturer, Distributor, User Facility
• Medical Institution (Hospital, Clinic etc)

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

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• 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

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For more information

• http//www.sfda.gov.cn
• http//www.cmdi.gov.cn
• My Email sfdawlm_at_126.com
• wlanming_at_sina.com

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