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Chinese Guidebook for Application and Approval of Imported Medical Device Registration Market 2016 Share, Trend, Segmentation and Forecast

Friday, November 4, 2016 2:17
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(Before It's News)

Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations for imported medical device 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 medical device market.

Request a sample report @ https://www.wiseguyreports.com/sample-request/5302-latest-chinese-guidebook-for-application-and-approval-of-imported-medical-device-registration-from-regulations-to-practices-2014-edition

Report Highlights

An overview of the latest Chinese applicable regulations for imported overseas medical device registration and recordation.

What the Chinese regulations on medical devices are undergoing earthshaking changes?

An overview of organizational structure of Chinese regulatory authorities for imported medical device registration and recordation to give the direction of gateway for imported medical device registration and recordation.

The knowledge preparation before application of imported overseas medical device registration and recordation to let overseas medical device manufacturer understand the unique Chinese approach for medical device registration and lay the knowledge foundation for the practical operation.

The latest Chinese regulations for application for imported medical device recordation, which is applicable to Class I imported overseas medical devices.

The latest Chinese regulations for application and approval for imported medical device registration, which is applicable to Class II and II imported overseas medical devices.

The detailed Chinese medical device classification.

The rights of human subjects and every party’s responsibilities in clinical trials for imported overseas medical devices in China.

The practical guidance for application of imported overseas medical device 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 medical device registration, also from how to compile application documents, how to conduct clinical trials for imported overseas medical devices to the application for approval of imported overseas medical device registration to smoothly navigate complex regulatory requirements step by step.

The practical guidance for alteration registration and renewal registration of imported overseas medical devices, 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 latest Chinese involving with the imported overseas medical device registration and recordation, which cover “Regulations for the Supervision and Administration of Medical Devices (2014 Edition)”, “Measures for the Administration of Medical Device Registration(2014 Edition)”, “Regulations on the Administration of the Instructions and Labels of Medical Devices (2014 Edition)”, “Provisions for Clinical Trials of Medical Devices”, and “Rules for Medical Device Classification”.

Complete report details @ https://www.wiseguyreports.com/reports/5302-latest-chinese-guidebook-for-application-and-approval-of-imported-medical-device-registration-from-regulations-to-practices-2014-edition

               

Key points in table of content

Chapter 1 Executive Summary.4
Chapter 2 Analysis and Research for Radical Change of Chinese Regulations on Medical Devices.8

2.1. What Chinese Regulations on Medical Devices are Undergoing Earthshaking Changes?.8
2.2. What is the Reason to Drive Chinese Regulations on Medical Devices Radical Change?.11
Chapter 3 Chinese Applicable Regulations for Medical Device Registration.14
Chapter 4 An Overview of Chinese Regulatory Authorities for Imported Medical Device Registration.16

4.1. CFDA’s Main Responsibilities.17
4.2. CFDA’s Organizational Structure.19
Figure 4.2.1. CFDA’s Organizational Structure.20
Table 4.2.1. CFDA’s affiliated organizations.21
4.3. Roadmap of Application and Approval for Imported Medical Device Registration.25
Figure 4.3.1. Roadmap of Examination and Approval for Imported Overseas Medical Device Registration.27 
Chapter 5 Knowledge Preparation before Application of Imported Medical Device Registration.28
5.1. Definitions.28
5.2. Classified Administration for Registration and Recordation of Medical Devices.29
5.3. What Medical devices may be exported into China.30
5.4. Regulations on Applicant or Filer for Imported Medical Device Registration or Recordation.30 
5.5. Product Technical Requirements.31
5.6. Registration Tests.32
5.7. Clinical Evaluation.33
Chapter 6 Medical Device Classification.36
6.1. Guidelines and Principles for Medical Device Classification.36
6.1.1. Guidelines for Medical Device Classification.37
6.1.2. Principles for Medical Device Classification.38
6.2. Judgment Table for Medical Device Classification.41
Table 6.2. Judgment Table for Medical Device Classification.42
Chapter 7 Rights of Human Subjects and Every Party’s Responsibilities in Clinical Trials for Imported Medical Devices.46
7.1.Rights and Interests of Human Subject.46
7.2.The Responsibilities for Implementer of Clinical Trials.47
7.3.    The Responsibilities for Medical Institutions and Personnel of Clinical Trials.48
Chapter 8 Application for Imported Medical Device Recordation.51
Chapter 9 Application and Approval for Imported Medical Device Registration.53

9.1. Application and Approval for Imported Medical Device Registration.53
9.2. Matters of Medical Device Registration.59
9.3. Administrative Reconsideration.60
9.4. Medical Device Registration Certificate and its Valid Time Limitation.60
Chapter 10 Application and Approval for Alteration Registration of Imported Medical Devices.62
Chapter 11 Application and Approval for Renewal Registration of Imported Medical Devices.63
Chapter 12 Supervision and Administration for Application and Approval of Imported Medical Device Registration.64
Chapter 13 Practical Guidance for Application of Imported Medical Device Recordation.65

13.1. Application for Imported Medical Device Recordation.66
13.1.1. Recordation Form of Class I Medical Device.66
Table 13.1.1 . Recordation Form of Class I Medical Device.67
13.1.2. List of Recordation Documents and Requirements for Recordation Documents .71
13.1.3. Requirements for Formal Examination of Recordation From and Documents .74
13.1.4. Operation Practices for Formal Examination of Recordation Documents.75
13.1.5. Recordation Certificate.77
Table 13.1.5. Recordation Certificate.77
13.2. Application for Alteration Recordation of Imported Medical Device.78
13.2.1. Form of Recordation Information.79
Table 13.2.1. Form of Recordation Information of Class I Medical Device.79
13.2.2. List of Alteration Recordation Documents and Requirements for Alteration Recordation Documents.81 
13.2.3. Operation Practices for Formal Examination of Alteration Recordation Information.83
Chapter 14 Practical Guidance for Application and Approval of Imported Medical Device Registration.85
14.1. Application Form for Registration of Imported Medical Device.86
Table 14.1. Application Form for Registration of Imported Medical Device.86
14.2. List of Registration Documents and Requirements for Registration Documents.93 
14.3. How to Compile the Product Technical Requirements.99
Table 14.3. Format Requirements for Product Technical Requirements of Medical Devices.102
14.4. How to Conduct the Clinical Trials for Medical Device.103
14.4.1. Application Form for Medical Device Clinical Trial.104 
Table 14.4.1. Application Form for Medical Device Clinical Trial.105
14.4.2. Notice of Medical Device Clinical Trials.108
14.4.3. Clinical Trials Protocol and Format of Clinical Trial Protocol for Medical Devices.109
Table 14.4.3. Format of Clinical Trial Protocol for Medical Devices.111
14.4.4. Clinical Trial Report and Format of Clinical Trial Report for Medical Devices.116
Table 14.4.4. Format of Clinical Trial Report for Medical Device.117
14.5. Submission of Application Documents.121
Chapter 15 Practical Guidance for Alteration Registration and Renewal Registration of Imported Medical Devices. 122
15.1. Practical Guidance for Alteration Registration of Imported Medical Devices.122
15.2. Practical Guidance for Renewal Registration of Imported Medical Devices.126
Chapter 16 Appendices.130
Appendix 1 Regulations for the Supervision and Administration of Medical Devices (2014 Edition).130
Appendix 2 Measures for the Administration of Medical Device Registration (2014 Edition).157
Appendix 3 Regulations on the Administration of the Instructions and Labels of Medical Devices (2014 Edition).177
Appendix 4 Provisions for Clinical Trials of Medical Devices.183
Appendix 5 Rules for Medical Device Classification.191

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