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  4. > Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China (2014 Edition)

Executive Summary

The Chinese medical device market is one of segment market of the most growth potentiality, which is attracting more and more overseas medical device manufacturers and producers to penetrate such market. It is estimated that Chinese medical device market will be likely to be more than 340 billion RMB (about 57 billion US dollars) by 2015, and will surpass Japan to become the second largest medical device market behind the United States.

However, China’s regulatory framework for medical devices is undergoing radical changes. China’s new leaders have recognized that the regulations for supervision and administration of medical devices 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 of June 1, 2014. China Food and Drug Administration issued the latest “Measures for the Administration of Medical Device Registration”, and it has come into force as of October 1, 2014. The overseas medical devices exporting into China market should be subject to administration of overall new regulations since October 1, 2014.

The Chinese administration system for medical device registration undergone significant changes. Chinese authorities have begun to strengthen the supervision and administration of its medical device market. To strictly examine and approve the application dossiers for oversea medical device registration in China has become as the key threshold of oversea medical device exporting into China. The Chinese approach to administer medical device registration is unique. The application and approval process, clinical evaluation and clinical trial, the requirements for application dossiers are distinct from in U.S. and EU countries.How do you in compliance with the latest Chinese regulations on medical devices? How do you operate business smoothly in China? How to seize a bigger Chinese medical device market? The preparation of application dossiers compliance with overall new regulations becomes as the key for oversea medical device entry into Chinese medical device market. The overseas and multinational medical device manufacturers must have a comprehensive and thorough knowledge of the latest Chinese regulations on medical device registration. Otherwise, the restrictive legal requirements and approval delays eat up your time and energy to achieve a successful entry into such a lucrative medical device market, and cause trouble for your business smoothly in China.

Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China (2014 Edition) not only provided a comprehensive and thorough knowledge of the overall new requirements of application dossiers for medical device registration or recordation in China but also provided the guidance of practical operation for how to achieve a successful approval for your products entry into the Chinese medical device market.

The organizations of this guidebook are arranged as follows. Chapter 2 provides a comprehensively comparative analysis to introduce what the Chinese regulations on medical device are undergoing radical changes. Chapter 3 introduces the framework of the latest applicable Chinese regulations for medical device registration and recordation to provide a comprehensive and thorough knowledge of the latest Chinese regulations for medical device registration and recordation. Chapter 4 elaborates the knowledge preparation before application of imported overseas medical device registration or recordation to let overseas medical device manufacturer understand the unique Chinese approach for medical device registration or recordation and lay the knowledge foundation for the practical operation. Chapter 5 introduces how many application dossiers for imported oversea medical device recordation should be prepared. Chapter 6 introduces the comprehensive and detailed requirements for application dossiers of imported oversea medical device recordation. Chapter 7 introduces how many application dossiers for imported oversea medical device registration should be prepared. Chapter 8 introduces the comprehensive and detailed requirements for application dossiers of imported oversea medical device registration. Chapter 9 provides a list of basic requirements for safety and effectiveness of medical device product, which is overall new requirements for imported overseas medical device registration in China. Chapter 10 elaborates the compilation of product technical requirements, which are also overall new requirements for imported overseas medical device registration in China. Chapter 11 introduces how to apply for registration test of imported overseas medical device. Chapter 12 elaborates the compilation of the instructions and labels of medical device. Chapter 13 provides the practical guidance for conducting the unique clinical evaluation for imported overseas medical device registration in China to help overseas medical device manufacturers to remove their confusion. Chapter 14 provides the practical guidance for conducting the clinical trials for imported overseas medical device registration in china, from what imported overseas medical devices need to conduct clinical trial and approval within Chinese territory, how to apply for clinical trial of imported medical device registration, how to compile application documents, how to select the clinical trial institutions and define every party's responsibilities in clinical trials to how to acquire the approval document for clinical trial of imported medical device registration to smoothly navigate complex regulatory requirements step by step. Chapter 15 introduces the approval process for imported overseas medical device registration to guide overseas and multinational medical device manufacturers how to submit the application dossiers, ultimately achieve a successful approval for products entry into the Chinese medical device market. Chapter 16 Appendices provide a complete set of full text in English of the latest Chinese regulations on medical devices, which over “Measures for the Administration of Medical Device Registration (2014Edition)”, “Regulations on the Administration of the Instructions and Labels of Medical Devices (2014 Edition)” “Rules for Medical Device Classification (2014Edition)”, “Compiling Guidelines of Product Technical Requirements for Medical Devices” and “Technical Guidance Principles for Clinical Evaluation of Medical Devices”.

The audiences of this guidebook are overseas medical device manufacturers wishing to enter into the Chinese medical device market, and multinational medical device companies have penetrated into the Chinese medical device market, and their senior executive officers engaging in regulatory affairs expecting to understand how to apply for registration or recordation of their medical device products in China, how to comply with the overall new Chinese regulations for medical device registration or recordation.

After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive and thorough knowledge of the overall new Chinese regulations on imported medical device registration and recordation but also the practical operation how to comply with the overall new requirements of application dossiers for overseas medical device registration and recordation in China. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas and multinational medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market, and smoothly operate their products in China.



Table Of Contents

Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China (2014 Edition)
Table of Contents.1

Chapter 1 Executive Summary.6

Chapter 2 What Chinese Regulations on Medical Device are Undergoing
Radical Changes ---- A Comprehensively Comparative Analysis.10
2.1. What Chinese Regulations on Medical Device are Undergoing Radical Changes?.10
2.2. What are Chinese Regulations on Medical Device Registration Significant Changes?.12
2.3. What are the Latest Requirements of Application Dossiers for Imported Overseas Medical Device Registration or Recordation in China?.14

Chapter 3 Latest Chinese Applicable Regulations for Medical Device Registration and Recordation.16

Chapter 4 Knowledge Preparation of Preparing Application Dossiers for Imported Oversea Medical Device Registration or Recordation.18
4.1. Definitions.19
4.2. Classified Administration for Registration and Recordation of Medical Devices.20
4.3. What Medical devices may be exported into China?.21
4.4. Regulations on Applicant or Filer for Imported Medical Device Registration or Recordation.21
4.5. Product Technical Requirements.22
4.6. Registration Tests.23
4.7. Clinical Evaluation.24

Chapter 5 How Many Application Dossiers for Imported Oversea Medical Device Recordation should be Prepared.26
Table 5 Titles of Application Dossiers for Imported Oversea Medical Device Recordation in China.27

Chapter 6 Requirements for Application Dossiers of Imported Oversea Medical Device Recordation.28
6.1?Recordation Form of Class I Medical Device.28
Table 6.1 . Recordation Form of Class I Medical Device.29
6.2. List of Application Dossiers for Recordation and Requirements for Application Dossiers for Recordation.33
6.2.1. Requirements of Content for Application Dossiers for Recordation.33
6.2.2. Requirements for Formal Examination of Recordation From and Application Dossiers for Recordation.37
6.2.3. Operation Practices for Formal Examination of Application Dossiers for Recordation.38
6.2.4. Recordation Certificate.40
Table 6.2.4. Recordation Certificate.40

Chapter 7 How Many Application Dossiers for Imported Oversea Medical Device Registration should be Prepared.41
Table 7 Titles of Application Dossiers for Imported Oversea Medical Device Registration in China.41

Chapter 8 Requirements for Application Dossiers of Imported Oversea Medical Device Registration.43
8.1?Application Form for Registration of Imported Medical Device.43
Table 8.1. Application Form for Registration of Imported Medical Device.44
8.2. Certificate Documents.46
8.3. List of basic requirements for safety and effectiveness of medical device Product.47
8. 4. Summary of Data.47
8.4.1. Summary.48
8. 4.2. Product Description.48
8. 4.3. Model and Specification.48
8.4.4. Interpretation of Package.48
8.4.5. Applicable People Group and Contraindications.49
8.4.6. Situation of Reference Similar Products or Previous Generation Product (if any).50
8.4.7. Other content should be noted.50

8.5. Research Data.51
8. 5.1. Research Data for Product Performance.51
8. 5.2. Evaluation Data of Biocompatibility.51
8.5.3. Research Data for Biological Safety.51
8.5.4. Research Data of Production Technical Process for Sterilization and Disinfection.52
8.5.5. Research Data for Valid Period and Packaging.52
8.5.6. Research Data for Preclinical Animals.52
8. 5.7. Research Data for Software.52
8. 5.8. Other Data.53
8. 6. Manufacturing Information.53
8.6.1. An overview of the production process for passive medical device.53
8.6.2. An overview of the production process for active medical device.53
8. 6.3. Description of Production Site.53
8. 7. Clinical Evaluation Data.54
8. 8. Analysis Data for Product Risk.54
8.9. Product Technical Requirements.54
8.10. Test Report for Product Registration.54
8. 11. Instruction (manual) of Product and Design sample drafts of label for minimum sale unit.55
8. 12. Declaration of Conformity.55

Chapter 9 List of Basic Requirements for Safety and Effectiveness of Medical Device Product.57
Table 9. List of Basic Requirements for Safety and Effectiveness of Medical Device Product.59
Chapter 10 How to Compile the Product Technical Requirements.75
10.1. Basic Requirements.75
10.2. Content Requirements.76
10.3. Format Requirements.77
Table 10.3. Format Requirements for Product Technical Requirements of Medical Devices.78
Chapter 11 How to Apply for Registration Test.79
Chapter 12 How to Compile the Instructions and Labels of Medical Devices.81
12.1. Definitions.82
12.2. Requirements of Content.82
Chapter 13 How to Conduct the Clinical Evaluation for Imported Overseas Medical Device Registration in China.87
13.1. Practical Guidance for Clinical Evaluation of Contrasting Product Applying for Registration with Products listed into the Catalogue of Exempted Clinical Trial Medical Devices.90
Table 13.1. Contrast Table of Content between the product applying for registration and the product listed into the Catalogue of Exempted Clinical Trial Medical Devices.91
13.2. Practical Guidance for Clinical Evaluation based on Clinical Data of Medical Devices with Same Varieties.91
Table 13.2.1.Contrast Items and Conclusion Requirements for the product applying for registration comparing with the products of same varieties.93
Table 13.2.2. Contrast Content between the product applying for registration and the products of same varieties.96
Figure 13. 2.3. Path of Clinical Evaluation based on Clinical Data of Medical Devices with Same Varieties.98
Annex 13.2.4. Proposed Essential Factors for Retrieve and Screen of Literatures.99
Figure13.2.4. Proposed Screening Process of Literatures.102
Table 13.2.5. Scheme of Retrieve and Screen of Literatures.103
Table 13.2.6.Report of Retrieve and Screen of Literatures.104
Table 13.2.7. Content and Format of Clinical Evaluation Report based on Clinical Data of Medical Devices of Same Varieties.107

Chapter 14 How to Conduct the Clinical Trials of Imported Medical Device Registration in China.112
14.1. How Many Medical Devices need to Conduct Clinical Trial and Approval within Chinese Territory?.112
Table 14.1. Catalogue of Class III Medical Devices Need to Clinical Trial Approval.114
14.2. Application Form for Approval of Medical Device Clinical Trial117
Table 14.2. Application Form for Approval of Medical Device Clinical Trial.117
14.3. Requirements for Application Documents for Approval of Medical Device Clinical Trial.122
14.4. How to Select the Clinical Trial Institutions.125
14.5. How to Define Every Party's Responsibilities in Clinical Trials126
14.5.1?The Responsibilities for Sponsor of Clinical Trials.127
14.5.2?The Responsibilities for Clinical Trial Institutions and Personnel of Clinical Trials.128
14.6. Notice of Medical Device Clinical Trials.130
14.7. Clinical Trials Protocol and Format of Clinical Trial Protocol for Medical Devices.131
Table 14.7. Format of Clinical Trial Protocol for Medical Devices.132
14.8. Submission of Application Documents.135
14.9. Approval Document for Medical Device Clinical Trial.136
Table 14.9. Approval Document for Medical Device Clinical Trial.138
14.10. Clinical Trial Report and Format of Clinical Trial Report for Medical Devices.140
Table 14.10. Format of Clinical Trial Report for Medical Device.141

Chapter 15 Submission of Application Dossiers and Approval Process.144
15.1. Formal Requirements for Application Dossiers for Registration.144
15.2. Operation Practices for Formal Examination of Application Dossiers for Registration.146
15.3. Approval Process.147
15.4. Medical Device Registration Certificate and its Valid Time Limitation.149

Chapter 16 Appendices.150
Appendix 1 Measures for the Administration of Medical Device Registration (2014 Edition).150
Appendix 2 Regulations on the Administration of the Instructions and Labels of Medical Devices (2014 Edition).168
Appendix 3 Rules for Medical Device Classification.173
Appendix 4 Compiling Guidelines of Product Technical Requirements for Medical Devices.181
Appendix 5 Technical Guidance Principles for Clinical Evaluation of Medical Devices.184




List of Tables

Table 5 Titles of Application Dossiers for Imported Oversea Medical Device Recordation in China.
Table 6.1 . Recordation Form of Class I Medical Device.
Table 6.2.4. Recordation Certificate
Table 7 Titles of Application Dossiers for Imported Oversea Medical Device Registration in China
Table 8.1. Application Form for Registration of Imported Medical Device
Table 9. List of Basic Requirements for Safety and Effectiveness of Medical Device Product
Table 10.3. Format Requirements for Product Technical Requirements of Medical Devices.
Table 13.1. Contrast Table of Content between the product applying for registration and the product listed into the Catalogue of Exempted Clinical Trial Medical Devices
Table 13.2.1.Contrast Items and Conclusion Requirements for the product applying for registration comparing with the products of same varieties.93
Table 13.2.2. Contrast Content between the product applying for registration and the products of same varieties
Table 13.2.5. Scheme of Retrieve and Screen of Literatures
Table 13.2.6.Report of Retrieve and Screen of Literatures.
Table 13.2.7. Content and Format of Clinical Evaluation Report based on Clinical Data of Medical Devices of Same Varieties.
Table 14.1. Catalogue of Class III Medical Devices Need to Clinical Trial Approval
Table 14.2. Application Form for Approval of Medical Device Clinical Trial
Table 14.7. Format of Clinical Trial Protocol for Medical Devices
Table 14.9. Approval Document for Medical Device Clinical Trial
Table 14.10. Format of Clinical Trial Report for Medical Device


List of Figures

Figure 13. 2.3. Path of Clinical Evaluation based on Clinical Data of Medical Devices with Same Varieties
Figure13.2.4. Proposed Screening Process of Literatures

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