Summary
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.
The organizations of this guidebook are arranged as follows. Chapter 2 provides the analysis and research for radical change of Chinese regulations on in-vitro diagnostic reagents. Chapter 3 introduces the framework of the latest Chinese applicable regulations for in-vitro diagnostic reagent registration to provide a comprehensive and thorough knowledge of the latest Chinese regulations for in-vitro diagnostic reagent registration. Chapter 4 provides an overview of the Chinese regulatory authorities - China Food and Drug Administration (CFDA) being responsible for approval for imported overseas in-vitro diagnostic reagent registration and recordation to give the direction of gateway for imported overseas in-vitro diagnostic reagent registration and recordation. Chapter 5 elaborates the 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. Chapter 6 elaborates the classification and naming principles for in-vitro diagnostic reagents to let overseas in-vitro diagnostic reagent manufacturer understand the Chinese in-vitro diagnostic reagent classification and nomenclature, because the imported overseas in-vitro diagnostic reagent registration must be in compliance with such classification and nomenclature of in-vitro diagnostic reagents. Chapter 7 introduces 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 step by step. Chapter 8 introduces the requirements for compilation of instruction of in-vitro diagnostic reagent registration. Chapter 9 introduces the regulations for application for imported in-vitro diagnostic reagent recordation, which is applicable to Class I imported overseas in-vitro diagnostic reagents. Chapter 10 provides the regulations for application and approval for imported in-vitro diagnostic reagent registration, which is applicable to Class II and III imported overseas in-vitro diagnostic reagents. Chapter 11 introduces the regulations for application and approval for alteration registration of imported overseas in-vitro diagnostic reagents. Chapter 12 introduces the regulations for renewal registration of imported overseas in-vitro diagnostic reagents. Chapter 13 introduces the regulations for supervision and administration for application and approval of imported overseas in-vitro diagnostic reagent registration and recordation. Chapter 14 provides 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. Chapter 15 provides 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. Chapter 16 provides 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. Chapter 17 Appendices provide a complete set of full text in English of the latest Chinese regulations for imported overseas in-vitro diagnostic reagent registration.
The audiences of this guidebook are overseas in-vitro diagnostic reagent manufacturers wishing to enter into the Chinese in-vitro diagnostic reagent market, and multinational in-vitro diagnostic reagent companies have penetrated into the Chinese in-vitro diagnostic reagent market, and their senior executive officers engaging in regulatory affairs expecting to understand how to apply for registration of their in-vitro diagnostic reagent products in China, how to comply with the latest Chinese regulations for in-vitro diagnostic reagent registration. After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive and thorough knowledge of the latest Chinese regulations on imported in-vitro diagnostic reagent registration but also the practical operation how to comply with the latest Chinese regulations. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas and multinational in-vitro diagnostic reagent manufacturers and producers to achieve a successful entry into the Chinese medical device market, and smoothly operate their products in China.
Report Highlights
Who should buy this report?
Chapter 1 Executive Summary 5
Chapter 2 Analysis and Research for Radical Change of Chinese Regulations on In Vitro Diagnostic Reagents 9
2.1. What the Chinese regulations on in-vitro diagnostic reagents are undergoing earthshaking changes? 9
2.2. What is the reason to drive Chinese regulations on in-vitro diagnostic reagents radical change? 11
Chapter 3 Latest Chinese Applicable Regulations for In-vitro Diagnostic Reagent Registration 14
Chapter 4 An Overview of Chinese Regulatory Authorities for Imported In-vitro Diagnostic Reagent Registration 17
4.1. CFDA’s Main Responsibilities 17
4.2. CFDA’s Organizational Structure 20
Figure 4.2.1. CFDA’s Organizational Structure 21
Table 4.2.1. CFDA’s affiliated organizations 22
Chapter 5 General Regulations for Imported In-vitro Diagnostic Reagent Registration 28
5.1. Definitions 29
5.2. Classified Administration for Registration and Recordation of In-vitro Diagnostic Reagents 30
5.3. What in-vitro diagnostic reagents may be exported into China? 31
5.4. Regulations on Applicant or Filer for Imported In-vitro Diagnostic Reagent Registration or Recordation 31
5.5. Product Technical Requirements 32
5.6. Registration Tests 33
5.7. Clinical Evaluation 34
Chapter 6 Classification and Naming Principles for In-vitro Diagnostic Reagents 39
6.1. Classification for In-vitro Diagnostic Reagents 39
Table 6.1. Judgment Table for Medical Device Classification 40
6.2. Naming Principles for In-vitro Diagnostic Reagents 46
Chapter 7 Clinical Trials of In-vitro Diagnostic Reagents 46
7.1. Basic Principles of Clinical Trials 47
7.1.1. Basic Requirements 47
7.1.2. Requirements for Clinical Trial Institutions and Personnel 48
7.2. Principles of Clinical Trial Design 49
7.2.1. Clinical Trial Scheme 49
7.2.2. Clinical Trial Methods 49
7.2.2.1. The Clinical Trial Methods for New Diagnostic Reagent Products 49
7.2.2.2. The Clinical Trial Methods for Products that Same Species Approved to be sold on Market 51
7.2.2.3. The Clinical Trial Methods for Products of Change Application and Approval for Registration 51
7.2.2.4. The Clinical Trial Methods for Imported In-vitro Diagnostic Reagent Registration 52
7.2.3. Sample Size of Clinical Trial 52
7.2.3.1. General Requirements 52
7.2.3.2. Special Requirements 53
7.2.4. Requirements for Signature and Seal of Clinical Trial Scheme 54
7.3. Clinical Trial Report 54
7.4. Clinical Trial Protocol 57
Chapter 8. Compilation of Instruction of In-vitro Diagnostic Reagent Registration 59
Chapter 9 Application for Imported In-vitro Diagnostic Reagent Recordation 64
Chapter 10 Application and Approval for Imported In-vitro Diagnostic Reagent Registration 67
10.1. Application and Approval for Imported In-vitro Diagnostic Reagent Registration 67
10.2. Matters of In-vitro Diagnostic Reagent Registration 73
10.3. Administrative Reconsideration 73
10.4. Medical Device Registration Certificate and its Valid Time Limitation 74
Chapter 11 Application and Approval for Alteration Registration of Imported In-vitro Diagnostic Reagents 75
Chapter 12 Application and Approval for Renewal Registration of Imported In-vitro Diagnostic Reagents 78
Chapter 13 Supervision and Administration for Application and Approval of Imported In-vitro Diagnostic Reagent Registration and Recordation 79
Chapter 14 Practical Guidance for Application of Imported In-vitro Diagnostic Reagent Recordation 80
14.1. Application for Imported In-vitro Diagnostic Reagent Recordation 81
14.1.1. Recordation Form of Class I Medical Device 81
Table 14.1.1. Recordation Form of Class I Medical Device 82
14.1.2. List of Recordation Documents and Requirements for Recordation Documents 85
14.1.3. Requirements for Formal Examination of Recordation Form and Documents 89
14.1.4. Operation Practices for Formal Examination of Recordation Documents 90
14.1.5. Recordation Certificate 91
Table 14.1.5 Recordation Certificate 92
14.2. Application for Alteration Recordation of Imported In-vitro Diagnostic Reagent 92
14.2.1. Form of Recordation Information 93
Table 14.2.1. Form of Recordation Information of Class I In-vitro Diagnostic Reagent 94
14.2.2. List of Alteration Recordation Documents and Requirements for Alteration Recordation Documents 96
14.2.3. Operation Practices for Formal Examination of Alteration Recordation Information 97
Chapter 15 Practical Guidance for Application and Approval of Imported In-vitro Diagnostic Reagent Registration 99
15.1. Application Form for Registration of Imported In-vitro Diagnostic Reagent 100
Table 15.1. Application Form for Registration of Imported In-vitro Diagnostic Reagent 100
15.2. List of Application Registration Documents and Requirements for Application Registration Documents 106
Table 15.2. The application documents for the initial application of imported in-vitro diagnostic reagent registration 106
15.3. How to Compile the Product Technical Requirements 114
Table 15.3. Format Requirements for Product Technical Requirements of Medical Devices 117
15.4. Submission of Application Documents 118
15.5. Medical Device Registration Certificate (for In-vitro Diagnostic Reagent ) 119
Table 15.5. Medical Device Registration Certificate (for In-vitro Diagnostic Reagent) 120
Chapter 16 Practical Guidance for Alteration Registration and Renewal Registration of Imported In vitro Diagnostic Reagent 122
16.1. Practical Guidance for Alteration Registration of Imported In vitro Diagnostic Reagent 122
16.1.1. List of Alteration Registration Documents and Requirements for Alteration Registration Documents for Alteration of Registration Matters 124
16.1.2 List of Alteration Registration Documents and Requirements for Alteration Registration Documents for Alteration of License Matters 126
16.1.3. Alteration Document of Medical Device Registration (for In-vitro Diagnostic Reagent) 131
Table 16.1.3. Alteration Document of Medical Device Registration (for In- vitro Diagnostic Reagent) 131
16.2. Practical Guidance for Renewal Registration of Imported In -vitro Diagnostic Reagent 133
Chapter 17 Appendices 137
Appendix 1 Regulations for the Supervision and Administration of Medical Devices (2014 Edition) 137
Appendix 2 Measures for the Administration of In Vitro Diagnostic Reagent Registration (2014 Edition) 163
Appendix 3 Rules for Medical Device Classification (2014) 187
Appendix 4 Technical Guidance Principles for Clinical Trials of In-vitro Diagnostic Reagents (2014 Edition) 191
Appendix 5 Guidance Principles for Compilation of Instruction of In-vitro Diagnostic Reagents (2014 Edition) 200
List of Tables
Table 4.2.1. CFDA’s affiliated organizations.
Table 6.1. Judgment Table for Medical Device Classification.
Table 14.1.1. Recordation Form of Class I Medical Device.
Table 14.1.5 Recordation Certificate.
Table 14.2.1. Form of Recordation Information of Class I In-vitro Diagnostic Reagent.
Table 15.1. Application Form for Registration of Imported In-vitro Diagnostic Reagent.
Table 15.2. The application documents for the initial application of imported in-vitro diagnostic reagent registration.
Table 15.3. Format Requirements for Product Technical Requirements of Medical Devices.
Table 15.5. Medical Device Registration Certificate (for In-vitro Diagnostic Reagent).
Table 16.1.3. Alteration Document of Medical Device Registration (for In- vitro Diagnostic Reagent).
List of Figures
Figure 4.2.1. CFDA’s Organizational Structure
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