Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration

Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration

Category : Medical Devices
January  2013  Pages : 179



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China is one of the fastest growing global economies with a fourth population in the world, and is one of the largest healthcare markets round the world. Along with sustained economic and population growth, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, in-vitro diagnostic reagents represented dynamical growth since 2007. By 2010, total value of in-vitro diagnostic reagents on Chinese healthcare market has reached 1.5 billion US dollars, an increase of 13.3% over 2009 level.
 
In 2009, the Chinese government vigorously launched “China’s Health-Care Reform”, developed an ambitious blueprint, in which health care system will cover about 1.2 billion people by 2011. The in-vitro diagnostic reagents have been widely used in the process of disease prevention, diagnosis, treatment monitoring, prognosis observation, health status evaluation and inherited disease prediction. It is estimated that Chinese in-vitro diagnostic reagent market is likely to be more than 20.8 billion RMB until 2015, and it is one of segment market of the most growth potentiality. The Chinese in-vitro diagnostic reagent market will attract more and more in-vitro diagnostic reagents produced by overseas manufacturers and producers to penetrate such market.
 
To enter such a lucrative in-vitro diagnostic reagent market, the first obstacle faced by overseas in-vitro diagnostic reagents manufacturers and producers is how to file the application for their imported in-vitro diagnostic reagent registration with Chinese regulatory authorities for in-vitro diagnostic reagents. In China, the process of application and approval for imported in-vitro diagnostic reagent registration is very complex, because the Chinese regulatory authorities for in-vitro diagnostic reagents administer and control this process by exorbitant administrative measures and regulations, moreover, these exorbitant administrative regulations are variable and lack of transparency. 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 in-vitro diagnostic reagents manufacturers and producers. Therefore, a detailed guidance of practical operation for application and approval of imported in-vitro diagnostic reagent registration and a comprehensive and thorough knowledge of the latest Chinese laws and regulations for imported in-vitro diagnostic reagent registration have been become an essential prerequisite for overseas in-vitro diagnostic reagents manufacturers and producers to achieve a successful application for their products entry into the Chinese in-vitro diagnostic reagent market.
 
China’s Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration is an essential resource for overseas in-vitro diagnostic reagents manufacturers and producers to achieve a successful application for their products entry into the Chinese in-vitro diagnostic reagent market. It provides not only a detailed guidance of practical operation for application and approval of imported in-vitro diagnostic reagent registration but also a comprehensive and thorough knowledge of the latest Chinese regulations for imported in-vitro diagnostic reagent registration to guide overseas in-vitro diagnostic reagents manufacturers and producers step by step to pass through the entirely legal procedures of application and approval for imported in-vitro diagnostic reagent registration smoothly.  
 
Report Highlights

  • An overview of the main responsibilities and organization structure of the SFDA (The State Food and Drug Administration) that is current Chinese regulatory authority being responsible for application and approval for imported in-vitro diagnostic reagent registration.
  • A framework of latest applicable Chinese laws and regulations for imported medical device registration to provide a comprehensive and thorough knowledge of the latest Chinese laws and regulations for imported in-vitro diagnostic reagent registration.
  • The general regulations for application and approval of imported in-vitro diagnostic reagent registration to provide a guidance of practical operation for application and approval of imported medical device registration.
  • An overview of entire process of application and approval for imported in-vitro diagnostic reagent registration, including the procedures of the initial application and approval for imported in-vitro diagnostic reagent registration, the application and approval for imported in-vitro diagnostic reagent re-registration.
  • The Chinese in-vitro diagnostic reagent classification, including the classification and the naming principles.
  • The guidance of clinical trials for imported in-vitro diagnostic reagent registration, including the detailed requirements for the clinical trial of imported in-vitro diagnostic reagent registration, from the basic principles of clinical trials, the trial methods, the clinical trial report and the clinical trial protocol.
  • The guidance of requirements for documents of application and approval of in-vitro diagnostic reagent registration, including the requirements on documents for the initial application of imported in-vitro diagnostic reagent registration, the requirements on documents for the application of imported in-vitro diagnostic reagent re-registration, and the requirements on documents for the application of change registration.
  • An entire set of the Chinese and English bilingual version of Application Form of Imported In-vitro Diagnostic Reagent Registration, including the Initial Application Form of Imported In-vitro Diagnostic Reagent Registration, the Application Form of Imported In-vitro Diagnostic Reagent Re-registration, the Application Form of Imported In-vitro Diagnostic Reagent Change Registration
  • The significant suggestions for overseas medical devices manufacturers and producers looking to achieve a successful application for their in-vitro diagnostic reagent registration in China.
  • The English versions of full latest Chinese administrative regulations and departmental regulations and provisions for in-vitro diagnostic reagent registration to facilitate overseas in-vitro diagnostic reagents manufacturers and producers to acquire a comprehensive knowledge of latest applicable Chinese regulations for imported in-vitro diagnostic reagent registration, including the Regulations for the Supervision and Administration of Medical Devices, the Measures for the Administration of Medical Device Registration, the Measures for the Administration of In-vitro Diagnostic Reagent Registration, the Principles on the Technical Guidance of Clinical Study of In--vitro Diagnostic Reagents, the Principles Guiding the Compiling of Instruction Manual of In--vitro Diagnostic Reagents.

 
Who should buy this report?

  • Senior executive officers engaging in regulatory and registration affairs for imported in-vitro diagnostic reagent registration in China.
  • Non-Chinese Companies wishing to enter a lucrative imported in-vitro diagnostic reagent market in China.
  • Non-Chinese Companies interested in understanding the latest Chinese regulations on application and approval for imported in-vitro diagnostic reagent registration.
  • Non-Chinese medical devices manufacturers and producers.

Table of Contents



Preface…1

Table of Contents.3

Chapter 1 Executive Summary.6

Chapter 2 An Overview of Chinese Regulatory Authorities for Medical Devices and In-vitro Diagnostic Reagents -- State Food and Drug Administration (SFDA).10


2.1. SFDA’s Main Responsibilities.10

2.2. SFDA’s Organization Structure 11

Figure 2.2. SFDA’s Organization Structure ….11

Table 2.2. SFDA’s Affiliated Organizations..13

Chapter 3 Chinese Laws and Regulations for Imported In-vitro diagnostic Reagent Registration….16

3.1. Chinese Legislation.16

3.2. Latest Applicable Administrative Regulations, and Departmental

Regulations, Provisions, Measures, and Guidance for In-vitro Diagnostic Reagent Registration……16

Chapter 4 General Regulations for Application and Approval of Imported In--vitro Diagnostic Reagent Registration……20

4.1. Definitions ……20

4.2. Regulatory Authorities for In-vitro Diagnostic Reagents …...20

4.3. Classified Registration and Administration of In-vitro Diagnostic Reagents …21

4.4. Medical Device Registration Certificate for In-vitro Diagnostic Reagent and its Valid Time Limitation…21

4.5. Application and Approval for Imported In-vitro Diagnostic Reagent Registration.22

4.5.1. Application and Approval for Initial Registration ….22

4.5.2. Product Standards and Registration Inspection ….23

4.5.3. Clinical Trial…24

4.5.4. Procedure of Application and Approval of In-vitro Diagnostic Reagent Registration.27

4.6. Application and Approval for Imported In-vitro Diagnostic Reagent Re-registration……29

4.7. Application and Approval for Change of In-vitro Diagnostic Reagent Registration….30

4.8. Withdrawal, Return and Review of Registration Application…..32

Chapter 5 Entire Process of Application and Approval for Imported In-vitro Diagnostic Reagent Registration.33

5.1. Process of Initial Application and Approval for Class II or III Imported In-vitro Diagnostic Reagent Registration …..33

Figure 5.1. Process of Initial Application and Approval for Class II or III Imported In-vitro Diagnostic Reagent Registration…34

5.2. Process of Application and Approval for Imported In-vitro Diagnostic Reagent Re-registration.35

Figure 5.2. Process of Application and Approval for Imported In-vitro Diagnostic Reagent Re-registration ….35

Chapter 6 Classification and Naming Principles for In-vitro Diagnostic Reagents…..36

6.1. Classification of In-vitro Diagnostic Reagents……36

6.2. Naming Principles for In-vitro Diagnostic Reagents…38

Chapter 7 Clinical Trials of In-vitro Diagnostic Reagents.39

7.1. Basic Principles of Clinical Trials ….40

7.1.1. Basic Requirements…..40

7.1.2. Requirements for Clinical Research Units and Personnel……40

7.2. Principles of Design for Clinical trials…..41

7.2.1. Trial Methods …..41

7.2.2. Sample Size of Clinical Trial …..43

7.3. Clinical Trial Report…...44

7.3.1. The First Chapter……44

7.3.2. Content of Body and Report Format….45

7.4. Clinical Trials Protocol.47

Chapter 8. Manual and Package, label for Application and Approval of In--vitro Diagnostic Reagent Registration.49

8.1. Manual for Application and Approval of In--vitro Diagnostic Reagent Registration.49

8.2. Package, Label for Application and Approval of In--vitro Diagnostic Reagent Registration..51

Chapter 9. Documents for Application and Approval of In-vitro Diagnostic Reagent Registration…53

9.1. The Documents for the Initial Application of Imported In-vitro Diagnostic Reagent Registration.53

9.1.1. The Documents for the Initial Application of In-vitro Diagnostic Reagent Registration.53

Table 9.1.1. The documents for the initial application of Imported

in-vitro diagnostic reagent registration…..53

9.1.2. Application Form of Imported In-vitro Diagnostic Reagent Registration..54

Table 9.1.2. Application Form of Imported In-vitro Diagnostic Reagent Registration..54

9.1.3. The Requirements for Application Documents and Materials…59

9.2. The Documents for the Application of Imported In-vitro Diagnostic Reagent Re-registration…64

9.2.1. Application Form of Imported In-vitro Diagnostic Reagent Re-registration……64

Table 9.2.1. Application Form of Imported In-vitro Diagnostic Reagent Re-registration…65

9.2.2. Qualification Certificates……69

9.2.3. A Summary Report for Product Quality, Clinical Use Situation and Adverse Events within the Validity Period of Medical Device Registration Certificate….70

9.2.4.A Statement for Applying Re-registration Product Whether Change with Original Registration Product……70

9.2.5. Assessment Report of the Quality Management System…..70

9.3. The Documents for Application of Change Registration of Imported In-vitro Diagnostic Reagent.70 

9.3.1. Application Form of Imported In-vitro Diagnostic Reagent Change Registration..71

Table 9.3.1. Application Form of Imported In-vitro Diagnostic Reagent Change Registration.71

9.3.2. Qualification Certificates…76

9.3.3. Qualification Certificates for Change Registration Issues…77

9.3.4. The Requirements on Documents and Materials for the Application Change Permission Issues.78

Chapter 9 Conclusion..80

Chapter 10 Appendices 86

Appendix 1 Regulations for the Supervision and Administration of Medical Devices.86

Appendix 2 Measures for the Administration of Medical Device Registration……102

Appendix 3 Measures for the Administration of In-vitro Diagnostic Reagent Registration (Interim)….. 136

Appendix 4 Principles on the Technical Guidance of Clinical Study of In--vitro Diagnostic Reagents….155

Appendix 5 Principles Guiding the Compiling of Instruction Manual of In--vitro Diagnostic Reagents..170

Appendix 6 Provisions for the Instructions, Labels and Package of Medical Devices….175


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