Latest Chinese Guidebook for Application and Approval of Imported In-Vitro Diagnostic Reagent Registration: From Regulations to Practices (2014 Edition)
China’s regulatory framework for in-vitro diagnostic reagents is undergoing earthshaking changes. The country’s new leaders have recognized that the regulations for supervision and administration of in-vitro diagnostic reagents are far from perfect along with rapid population growth and thriving economy over the past 30 years. Chinese state council issued the latest “Regulations for the Supervision and Administration of Medical Devices” on February 12, 2014, and it has come into force as June 1, 2014. Before long, China Food and Drug Administration issued a series of the latest regulations on in-vitro diagnostic reagents on July 30, 2014 respectively, and they will come into force as October 1, 2014. The overseas in-vitro diagnostic reagents exporting into China market will be subject to administration of overall new regulations on in-vitro diagnostic reagent registration since October 1, 2014.
China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth as well as an ageing population, 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 2013, total value of in-vitro diagnostic reagents on Chinese healthcare market has reached 3.5 billion US dollars, an increase of 22.9% over 2012 level. It is estimated that Chinese in-vitro diagnostic reagent market is likely to be more than 5.5 billion US dollars until 2015, and it is one of segment market of the most growth potentiality. The Chinese in-vitro diagnostic reagent market is attracting more and more in-vitro diagnostic reagents produced by overseas and multinational manufacturers to penetrate such market.
However, China’s radical change of regulatory framework for in-vitro diagnostic reagents will bring overseas and multinational in-vitro diagnostic reagent manufacturers the maximum challenges and opportunities. How do you in compliance with the latest Chinese regulations on in-vitro diagnostic reagents? How do you operate business smoothly in China? To enter such a lucrative in-vitro diagnostic reagent market, overseas and multinational in-vitro diagnostic reagent manufacturers must have a comprehensive and thorough knowledge of the latest Chinese regulations on in-vitro diagnostic reagent registration. Otherwise, the restrictive legal requirements and approval delays eat up your time and energy to achieve a successful entry into such a lucrative in-vitro diagnostic reagent market, and cause trouble for your business smoothly in China.
Latest Chinese Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration: From Regulations to Practices (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations for imported in-vitro diagnostic reagent registration but also introduced the practical operation how to comply with the Chinese regulations to guide you achieve a successful approval for your products entry into the Chinese in-vitro diagnostic reagent market.
Report Highlights
China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth as well as an ageing population, 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 2013, total value of in-vitro diagnostic reagents on Chinese healthcare market has reached 3.5 billion US dollars, an increase of 22.9% over 2012 level. It is estimated that Chinese in-vitro diagnostic reagent market is likely to be more than 5.5 billion US dollars until 2015, and it is one of segment market of the most growth potentiality. The Chinese in-vitro diagnostic reagent market is attracting more and more in-vitro diagnostic reagents produced by overseas and multinational manufacturers to penetrate such market.
However, China’s radical change of regulatory framework for in-vitro diagnostic reagents will bring overseas and multinational in-vitro diagnostic reagent manufacturers the maximum challenges and opportunities. How do you in compliance with the latest Chinese regulations on in-vitro diagnostic reagents? How do you operate business smoothly in China? To enter such a lucrative in-vitro diagnostic reagent market, overseas and multinational in-vitro diagnostic reagent manufacturers must have a comprehensive and thorough knowledge of the latest Chinese regulations on in-vitro diagnostic reagent registration. Otherwise, the restrictive legal requirements and approval delays eat up your time and energy to achieve a successful entry into such a lucrative in-vitro diagnostic reagent market, and cause trouble for your business smoothly in China.
Latest Chinese Guidebook for Application and Approval of Imported In-vitro Diagnostic Reagent Registration: From Regulations to Practices (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations for imported in-vitro diagnostic reagent registration but also introduced the practical operation how to comply with the Chinese regulations to guide you achieve a successful approval for your products entry into the Chinese in-vitro diagnostic reagent market.
Report Highlights
- An analysis and research for radical change of Chinese regulations on in-vitro diagnostic reagents.
- An overview of the latest Chinese applicable regulations for for in-vitro diagnostic reagent registration.
- An overview of organizational structure of Chinese regulatory authorities for imported overseas in-vitro diagnostic reagent registration and recordation to give the direction of gateway for imported overseas in-vitro diagnostic reagent registration.
- The Chinese general regulations for imported overseas in-vitro diagnostic reagent registration to let overseas in-vitro diagnostic reagent manufacturer understand the unique Chinese approach for in-vitro diagnostic reagent registration and lay the knowledge foundation for the practical operation.
- The detailed Chinese classification and naming principles for in-vitro diagnostic reagents.
- The Chinese unique requirements for clinical trials of in-vitro diagnostic reagents, from the basic principles of clinical trials, the clinical trial design, scheme and methods, the sample size of clinical trial, to the clinical trial report and protocol.
- The requirements for compilation of instruction of in--vitro diagnostic reagent registration in China.
- The practical guidance for application of imported overseas in-vitro diagnostic reagent recordation, from how to compile recordation documents, how to apply for recordation to how to handle alteration recordation to smoothly navigate complex regulatory requirements step by step.
- The practical guidance for application and approval of imported overseas in-vitro diagnostic reagent registration, also from how to compile application documents, how to compile the product technical requirements, how to apply for approval of imported overseas in-vitro diagnostic reagent registration to how to submit application documents to smoothly navigate complex regulatory requirements step by step.
- The practical guidance for alteration registration and renewal registration of imported overseas in-vitro diagnostic reagents, also from how to compile application documents to how to submit application documents step by step.
- A complete set of full text in English of the latest Chinese regulations for imported overseas in-vitro diagnostic reagent registration, which cover “Regulations for the Supervision and Administration of Medical Devices”, “Measures for the Administration of In Vitro Diagnostic Reagent Registration”, “Rules for Medical Device Classification”, “Technical Guidance Principles for Clinical Trials of In--vitro Diagnostic Reagents” and “Guidance Principles for Compilation of Instruction of In--vitro Diagnostic Reagents ”.
CHAPTER 1 EXECUTIVE SUMMARY
CHAPTER 2 ANALYSIS AND RESEARCH FOR RADICAL CHANGE OF CHINESE REGULATIONS ON IN VITRO DIAGNOSTIC REAGENTS
2.1. What the Chinese regulations on in-vitro diagnostic reagents are undergoing earthshaking changes?
2.2. What is the reason to drive Chinese regulations on in-vitro diagnostic reagents radical change?
CHAPTER 3 LATEST CHINESE APPLICABLE REGULATIONS FOR IN-VITRO DIAGNOSTIC REAGENT REGISTRATION
CHAPTER 4 AN OVERVIEW OF CHINESE REGULATORY AUTHORITIES FOR IMPORTED IN-VITRO DIAGNOSTIC REAGENT REGISTRATION
4.1. CFDA’s Main Responsibilities
4.2. CFDA’s Organizational Structure
Figure 4.2.1. CFDA’s Organizational Structure
Table 4.2.1. CFDA’s affiliated organizations
CHAPTER 5 GENERAL REGULATIONS FOR IMPORTED IN-VITRO DIAGNOSTIC REAGENT REGISTRATION
5.1. Definitions
5.2. Classified Administration for Registration and Recordation of In-vitro Diagnostic Reagents
5.3. What in-vitro diagnostic reagents may be exported into China?
5.4. Regulations on Applicant or Filer for Imported In-vitro Diagnostic Reagent Registration or Recordation
5.5. Product Technical Requirements
5.6. Registration Tests
5.7. Clinical Evaluation
CHAPTER 6 CLASSIFICATION AND NAMING PRINCIPLES FOR IN-VITRO DIAGNOSTIC REAGENTS
6.1. Classification for In-vitro Diagnostic Reagents
Table 6.1. Judgment Table for Medical Device Classification
6.2. Naming Principles for In-vitro Diagnostic Reagents
CHAPTER 7 CLINICAL TRIALS OF IN-VITRO DIAGNOSTIC REAGENTS
7.1. Basic Principles of Clinical Trials
7.1.1. Basic Requirements
7.1.2. Requirements for Clinical Trial Institutions and Personnel
7.2. Principles of Clinical Trial Design
7.2.1. Clinical Trial Scheme
7.2.2. Clinical Trial Methods
7.2.2.1. The Clinical Trial Methods for New Diagnostic Reagent Products
7.2.2.2. The Clinical Trial Methods for Products that Same Species Approved to be sold on Market
7.2.2.3. The Clinical Trial Methods for Products of Change Application and Approval for Registration
7.2.2.4. The Clinical Trial Methods for Imported In-vitro Diagnostic Reagent Registration.52
7.2.3. Sample Size of Clinical Trial
7.2.3.1. General Requirements
7.2.3.2. Special Requirements
7.2.4. Requirements for Signature and Seal of Clinical Trial Scheme
7.3. Clinical Trial Report
7.4. Clinical Trial Protocol
CHAPTER 8. COMPILATION OF INSTRUCTION OF IN--VITRO DIAGNOSTIC REAGENT REGISTRATION
CHAPTER 9 APPLICATION FOR IMPORTED IN--VITRO DIAGNOSTIC REAGENT RECORDATION
CHAPTER 10 APPLICATION AND APPROVAL FOR IMPORTED IN--VITRO DIAGNOSTIC REAGENT REGISTRATION
10.1. Application and Approval for Imported In--vitro Diagnostic Reagent Registration
10.2. Matters of In-vitro Diagnostic Reagent Registration
10.3. Administrative Reconsideration
10.4. Medical Device Registration Certificate and its Valid Time Limitation
CHAPTER 11 APPLICATION AND APPROVAL FOR ALTERATION REGISTRATION OF IMPORTED IN-VITRO DIAGNOSTIC REAGENTS
CHAPTER 12 APPLICATION AND APPROVAL FOR RENEWAL REGISTRATION OF IMPORTED IN-VITRO DIAGNOSTIC REAGENTS
CHAPTER 13 SUPERVISION AND ADMINISTRATION FOR APPLICATION AND APPROVAL OF IMPORTED IN-VITRO DIAGNOSTIC REAGENT REGISTRATION AND RECORDATION
CHAPTER 14 PRACTICAL GUIDANCE FOR APPLICATION OF IMPORTED IN-VITRO DIAGNOSTIC REAGENT RECORDATION
14.1. Application for Imported In-vitro Diagnostic Reagent Recordation
14.1.1. Recordation Form of Class I Medical Device
Table 14.1.1. Recordation Form of Class I Medical Device
14.1.2. List of Recordation Documents and Requirements for Recordation Documents
14.1.3. Requirements for Formal Examination of Recordation Form and Documents
14.1.4. Operation Practices for Formal Examination of Recordation Documents
14.1.5. Recordation Certificate
Table 14.1.5 Recordation Certificate
14.2. Application for Alteration Recordation of Imported In-vitro Diagnostic Reagent
14.2.1. Form of Recordation Information
Table 14.2.1. Form of Recordation Information of Class I In-vitro Diagnostic Reagent
14.2.2. List of Alteration Recordation Documents and Requirements for Alteration Recordation Documents
14.2.3. Operation Practices for Formal Examination of Alteration Recordation Information
CHAPTER 15 PRACTICAL GUIDANCE FOR APPLICATION AND APPROVAL OF IMPORTED IN-VITRO DIAGNOSTIC REAGENT REGISTRATION
15.1. Application Form for Registration of Imported In-vitro Diagnostic Reagent
Table 15.1. Application Form for Registration of Imported In-vitro Diagnostic Reagent
15.2. List of Application Registration Documents and Requirements for Application Registration Documents
Table 15.2. The application documents for the initial application of imported in-vitro diagnostic reagent registration
15.3. How to Compile the Product Technical Requirements
Table 15.3. Format Requirements for Product Technical Requirements of Medical Devices
15.4. Submission of Application Documents
15.5. Medical Device Registration Certificate (for In-vitro Diagnostic Reagent )
Table 15.5. Medical Device Registration Certificate (for In-vitro Diagnostic Reagent)
CHAPTER 16 PRACTICAL GUIDANCE FOR ALTERATION REGISTRATION AND RENEWAL REGISTRATION OF IMPORTED IN VITRO DIAGNOSTIC REAGENT
16.1. Practical Guidance for Alteration Registration of Imported In vitro Diagnostic Reagent
16.1.1. List of Alteration Registration Documents and Requirements for Alteration Registration Documents for Alteration of Registration Matters
16.1.2 List of Alteration Registration Documents and Requirements for Alteration Registration Documents for Alteration of License Matters
16.1.3. Alteration Document of Medical Device Registration (for In-vitro Diagnostic Reagent)
Table 16.1.3. Alteration Document of Medical Device Registration (for In- vitro Diagnostic Reagent)
16.2. Practical Guidance for Renewal Registration of Imported In -vitro Diagnostic Reagent
CHAPTER 17 APPENDICES
Appendix 1 Regulations for the Supervision and Administration of Medical Devices (2014 Edition)
Appendix 2 Measures for the Administration of In Vitro Diagnostic Reagent Registration (2014 Edition)
Appendix 3 Rules for Medical Device Classification (2014)
Appendix 4 Technical Guidance Principles for Clinical Trials of In--vitro Diagnostic Reagents (2014 Edition)
Appendix 5 Guidance Principles for Compilation of Instruction of In--vitro Diagnostic Reagents (2014 Edition)
CHAPTER 2 ANALYSIS AND RESEARCH FOR RADICAL CHANGE OF CHINESE REGULATIONS ON IN VITRO DIAGNOSTIC REAGENTS
2.1. What the Chinese regulations on in-vitro diagnostic reagents are undergoing earthshaking changes?
2.2. What is the reason to drive Chinese regulations on in-vitro diagnostic reagents radical change?
CHAPTER 3 LATEST CHINESE APPLICABLE REGULATIONS FOR IN-VITRO DIAGNOSTIC REAGENT REGISTRATION
CHAPTER 4 AN OVERVIEW OF CHINESE REGULATORY AUTHORITIES FOR IMPORTED IN-VITRO DIAGNOSTIC REAGENT REGISTRATION
4.1. CFDA’s Main Responsibilities
4.2. CFDA’s Organizational Structure
Figure 4.2.1. CFDA’s Organizational Structure
Table 4.2.1. CFDA’s affiliated organizations
CHAPTER 5 GENERAL REGULATIONS FOR IMPORTED IN-VITRO DIAGNOSTIC REAGENT REGISTRATION
5.1. Definitions
5.2. Classified Administration for Registration and Recordation of In-vitro Diagnostic Reagents
5.3. What in-vitro diagnostic reagents may be exported into China?
5.4. Regulations on Applicant or Filer for Imported In-vitro Diagnostic Reagent Registration or Recordation
5.5. Product Technical Requirements
5.6. Registration Tests
5.7. Clinical Evaluation
CHAPTER 6 CLASSIFICATION AND NAMING PRINCIPLES FOR IN-VITRO DIAGNOSTIC REAGENTS
6.1. Classification for In-vitro Diagnostic Reagents
Table 6.1. Judgment Table for Medical Device Classification
6.2. Naming Principles for In-vitro Diagnostic Reagents
CHAPTER 7 CLINICAL TRIALS OF IN-VITRO DIAGNOSTIC REAGENTS
7.1. Basic Principles of Clinical Trials
7.1.1. Basic Requirements
7.1.2. Requirements for Clinical Trial Institutions and Personnel
7.2. Principles of Clinical Trial Design
7.2.1. Clinical Trial Scheme
7.2.2. Clinical Trial Methods
7.2.2.1. The Clinical Trial Methods for New Diagnostic Reagent Products
7.2.2.2. The Clinical Trial Methods for Products that Same Species Approved to be sold on Market
7.2.2.3. The Clinical Trial Methods for Products of Change Application and Approval for Registration
7.2.2.4. The Clinical Trial Methods for Imported In-vitro Diagnostic Reagent Registration.52
7.2.3. Sample Size of Clinical Trial
7.2.3.1. General Requirements
7.2.3.2. Special Requirements
7.2.4. Requirements for Signature and Seal of Clinical Trial Scheme
7.3. Clinical Trial Report
7.4. Clinical Trial Protocol
CHAPTER 8. COMPILATION OF INSTRUCTION OF IN--VITRO DIAGNOSTIC REAGENT REGISTRATION
CHAPTER 9 APPLICATION FOR IMPORTED IN--VITRO DIAGNOSTIC REAGENT RECORDATION
CHAPTER 10 APPLICATION AND APPROVAL FOR IMPORTED IN--VITRO DIAGNOSTIC REAGENT REGISTRATION
10.1. Application and Approval for Imported In--vitro Diagnostic Reagent Registration
10.2. Matters of In-vitro Diagnostic Reagent Registration
10.3. Administrative Reconsideration
10.4. Medical Device Registration Certificate and its Valid Time Limitation
CHAPTER 11 APPLICATION AND APPROVAL FOR ALTERATION REGISTRATION OF IMPORTED IN-VITRO DIAGNOSTIC REAGENTS
CHAPTER 12 APPLICATION AND APPROVAL FOR RENEWAL REGISTRATION OF IMPORTED IN-VITRO DIAGNOSTIC REAGENTS
CHAPTER 13 SUPERVISION AND ADMINISTRATION FOR APPLICATION AND APPROVAL OF IMPORTED IN-VITRO DIAGNOSTIC REAGENT REGISTRATION AND RECORDATION
CHAPTER 14 PRACTICAL GUIDANCE FOR APPLICATION OF IMPORTED IN-VITRO DIAGNOSTIC REAGENT RECORDATION
14.1. Application for Imported In-vitro Diagnostic Reagent Recordation
14.1.1. Recordation Form of Class I Medical Device
Table 14.1.1. Recordation Form of Class I Medical Device
14.1.2. List of Recordation Documents and Requirements for Recordation Documents
14.1.3. Requirements for Formal Examination of Recordation Form and Documents
14.1.4. Operation Practices for Formal Examination of Recordation Documents
14.1.5. Recordation Certificate
Table 14.1.5 Recordation Certificate
14.2. Application for Alteration Recordation of Imported In-vitro Diagnostic Reagent
14.2.1. Form of Recordation Information
Table 14.2.1. Form of Recordation Information of Class I In-vitro Diagnostic Reagent
14.2.2. List of Alteration Recordation Documents and Requirements for Alteration Recordation Documents
14.2.3. Operation Practices for Formal Examination of Alteration Recordation Information
CHAPTER 15 PRACTICAL GUIDANCE FOR APPLICATION AND APPROVAL OF IMPORTED IN-VITRO DIAGNOSTIC REAGENT REGISTRATION
15.1. Application Form for Registration of Imported In-vitro Diagnostic Reagent
Table 15.1. Application Form for Registration of Imported In-vitro Diagnostic Reagent
15.2. List of Application Registration Documents and Requirements for Application Registration Documents
Table 15.2. The application documents for the initial application of imported in-vitro diagnostic reagent registration
15.3. How to Compile the Product Technical Requirements
Table 15.3. Format Requirements for Product Technical Requirements of Medical Devices
15.4. Submission of Application Documents
15.5. Medical Device Registration Certificate (for In-vitro Diagnostic Reagent )
Table 15.5. Medical Device Registration Certificate (for In-vitro Diagnostic Reagent)
CHAPTER 16 PRACTICAL GUIDANCE FOR ALTERATION REGISTRATION AND RENEWAL REGISTRATION OF IMPORTED IN VITRO DIAGNOSTIC REAGENT
16.1. Practical Guidance for Alteration Registration of Imported In vitro Diagnostic Reagent
16.1.1. List of Alteration Registration Documents and Requirements for Alteration Registration Documents for Alteration of Registration Matters
16.1.2 List of Alteration Registration Documents and Requirements for Alteration Registration Documents for Alteration of License Matters
16.1.3. Alteration Document of Medical Device Registration (for In-vitro Diagnostic Reagent)
Table 16.1.3. Alteration Document of Medical Device Registration (for In- vitro Diagnostic Reagent)
16.2. Practical Guidance for Renewal Registration of Imported In -vitro Diagnostic Reagent
CHAPTER 17 APPENDICES
Appendix 1 Regulations for the Supervision and Administration of Medical Devices (2014 Edition)
Appendix 2 Measures for the Administration of In Vitro Diagnostic Reagent Registration (2014 Edition)
Appendix 3 Rules for Medical Device Classification (2014)
Appendix 4 Technical Guidance Principles for Clinical Trials of In--vitro Diagnostic Reagents (2014 Edition)
Appendix 5 Guidance Principles for Compilation of Instruction of In--vitro Diagnostic Reagents (2014 Edition)
