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Published Date: November 2014
Page Count: 190
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Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China (2014 Edition)

Summary Table of contents
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

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