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Latest Guide to Chinese Medical Device GMP Regulations

China is one of the fastest growing global economies with a fourth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, medical devices represented dynamical growth since 2000s. By 2010, total value of medical devices on Chinese healthcare market has reached 120 billion RMB. It is estimated that within the next few years, Chinese medical device market will be likely to be more than 600 billion RMB, and will surpass Japan to become the second largest medical device market following the United States. The Chinese medical device market will attract more and more overseas medical device manufacturers and producers to penetrate such market.

To enter the Chinese lucrative medical device market, the first obstacle faced by overseas medical device manufacturers and producers is how to comply with the Chinese Good Manufacturing Practice (GMP) Regulations for Medical Devices. Lack of knowledge of the Chinese laws and administrative regulations, and the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas medical device manufacturers and producers. Therefore, a comprehensive and thorough knowledge of the latest Chinese Good Manufacturing Practice (GMP) Regulations for Medical Devices has been become an essential prerequisite for overseas medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market, so more and more overseas medical device companies and multinational medical device companies, and their senior executive officers engaging in regulatory affairs expect to understand the latest Chinese Medical Device GMP regulations.

‘Latest Guide to Chinese Medical Device GMP Regulations’ is an essential resource for overseas medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market, which provides a detailed guidance of comprehensive and thorough knowledge of the latest Chinese Good Manufacturing Practice (GMP) Regulations for Medical Devices.

The Chinese regulatory authorities for medical devices, the State Food and Drug Administration(SFDA) issued the latest Medical Device GMP regulations in December 2009, including the Good Manufacturing Practice (GMP) for Medical Devices (Interim), the Regulations on Inspection of Good Manufacturing Practice (GMP) for Medical Devices (Interim), the Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Sterile Medical Devices (Interim), and the Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Implantable Medical Devices (Interim), which all came into effect as of January 1, 2011.

The organizations of this guidebook are arranged as follows. Chapter 2 provides the organizational structure of Chinese regulatory authorities for medical device GMP regulations. Chapter 3 provides an overview of Good Manufacturing Practice (GMP) for Medical Devices, which are comprehensive regulations to regulate a manufacturer's quality management system throughout the process - from design, development and manufacturing to sales and after-sale service. Chapter 4 introduces the details of the Regulations on Inspection of Good Manufacturing Practice (GMP) for Medical Devices. Chapter 5 introduces the Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Sterile Medical Devices in detail. Chapter 6 provides the detailed comprehensive guidance of Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Implantable Medical Devices.

Guidebook Highlights

  • An overview of Good Manufacturing Practice (GMP) for Medical Devices.
  • The details of Regulations on Inspection of Good Manufacturing Practice (GMP) for Medical Devices.
  • The Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Sterile Medical Devices
  • The Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Implantable Medical Devices
  • A full set of the English and Chinese bilingual application and inspection forms of Good Manufacturing Practice for Medical Devices.
  • An overview of the entire application and inspection procedure for Medical Device GMP.
  • The comprehensive inspection items and inspection contents of GMP for Sterile Medical Device and Implantable Medical Device.

Table of Contents

Table of Contents

Chapter 1 - Introduction

Chapter 2 - Chinese Regulatory Authorities for Medical Device GMP Regulations

  • Figure 2.1. Organizational Structure of Chinese Regulatory Authorities for Medical Device GMP Regulations

Chapter 3 - An Overview of Good Manufacturing Practice (GMP) for Medical Devices

  • 3.1. General Provisions
  • 3.2. Glossary
  • 3.3. Management Responsibilities
  • 3.4. Management of Resources
  • 3.5. Documents and Records
  • 3.6. Design and Development
  • 3.7. Purchase
  • 3.8. Manufacturing Management
  • 3.9. Monitoring and Measurement
  • 3.10. Distribution and Service
  • 3.11. Control of Disqualified Products
  • 3.12. Customer Complaint and Adverse Event Monitoring
  • 3.13. Analysis and Improvement

Chapter 4 - Inspection of Good Manufacturing Practice (GMP) for Medical Devices

  • 4.1. Regulatory Authorities for Medical Device GMP Inspection
  • 4.2. Application and Material Review
  • 4.3. On-site Inspection
  • 4.4. Inspection Conclusion
  • 4.5. Supervision for Inspection
  • 4.6. Management for Inspectors
  • 4.7. Appendixes
    • 4.7.1. Application Form of Inspection for Good Manufacturing Practice for Medical Devices (Appendix 1)
    • 4.7.2. Review Form of Inspection Materials for Medical Device Good Manufacturing Practices (Appendix 2)
    • 4.7.3. Record Form of On-site Inspection for Medical Device Good Manufacturing Practices (Appendix 3)
    • 4.7.4. Summary Form of On-site Inspection for Medical Device Good Manufacturing Practices (Appendix 4)
    • 4.7.5. Opinion Form of On-site Inspection for Medical Device Good Manufacturing Practices (Appendix 5)
    • 4.7.6. Notice of Medical Device Good Manufacturing Practice Inspection Results (Appendix 6)
    • 4.7.7. Opinions on Supervision and Inspection for Medical Device Good Manufacturing Practices (Appendix 7)
  • 4.8. An Overview of Application and Inspection Procedure for Medical Device GMP
    • Figure 4.8.1. Application and Inspection Procedure for High-risk
    • Class III Medical Device GMP ( regulated by CDC)
    • Figure 4.8.2. Application and Inspection Procedure for Class II and III
    • Medical Device GMP ( regulated by FDAs at provincial level)

Chapter 5 - Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Sterile Medical Devices

  • 5.1. Implementation Guidelines of Good Manufacturing Practice (GMP) for Sterile Medical Devices
    • 5.1.1. General Provisions
    • 5.1.2. Glossary
    • 5.1.3. Management Responsibilities
    • 5.1.4.Management of Resources
    • 5.1.5. Documents and Records
    • 5.1.6. Design and Development
    • 5.1.7. Purchase
    • 5.1.8. Manufacturing Management
    • 5.1.9. Monitoring and Measurement
    • 5.1.10. Distribution and Service
    • 5.1.11. Control of Disqualified Products
    • 5.1.12. Customer Complaint and Adverse Event Monitoring
    • 5.1.13. Analysis and Improvement
  • 5.2. Inspection Criteria of Good Manufacturing Practice (GMP) for Sterile Medical Devices
    • 5.2.1. Inspection Method
      • Table 5.2.1. Form of Inspection Results Evaluation for Sterile Medical Device GMP
    • 5.2.2. Inspection Items and Inspection Contents
      • Table 5.2.2. Form of Inspection Items and Inspection Contents for Sterile Medical Device GMP
  • 5.3. Appendix: Setting Principles of Sterile Medical Device Production Clean Room (Area)
    • Table 5.3. Air Cleanliness Level of Clean Rooms (Areas)

Chapter 6 - Implementation Guidelines and Inspection Criteria of Good Manufacturing Practice (GMP) for Implantable Medical Devices

  • 6.1. Implementation Guidelines of Good Manufacturing Practice (GMP) for Implantable Medical Devices
    • 6.1.1. General Provisions
    • 6.1.2. Glossary
    • 6.1.3. Management Responsibilities
    • 6.1.4. Management of Resources
    • 6.1.5. Documents and Records
    • 6.1.6. Design and Development
    • 6.1.7. Purchase
    • 6.1.8. Manufacturing Management
    • 6.1.9. Monitoring and Measurement
    • 6.1.10. Distribution and Service
    • 6.1.11. Control of Disqualified Products
    • 6.1.12. Customer Complaint and Adverse Event Monitoring
    • 6.1.13. Analysis and Improvement
  • 6.2. Inspection Criteria of Good Manufacturing Practice (GMP) for Implantable Medical Devices
    • 6.2.1. Inspection Method
      • Table 6.2.1. Form of Inspection Results Evaluation for Implantable Medical Device GMP
    • 6.2.2. Inspection Items and Inspection Contents
      • Table 6.2.2. Form of Inspection Items and Inspection Contents for Implantable Medical Device GMP
  • 6.3. Appendix: Setting Principles of Sterile Implantable Medical Device Production Clean Room (Area)
    • Table 6.3. Air Cleanliness Level of Clean Rooms (Areas)
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