Latest Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices (2014 Edition)

  • ID: 3005916
  • Report
  • Region: China
  • 199 Pages
  • Access China Management Consulting Ltd
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China’s regulatory framework for medical devices is undergoing radical changes. The country’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, which has come into force as of June 1, 2014. Before long, China Food and Drug Administration (hereafter called as CFDA) issued the latest “Measures for the Administration of Medical Device Registration”, which has come into force as of October 1, 2014.The overseas medical devices exporting into China market are subject to administration of overall new regulations on medical device registration since October 1, 2014.

The Chinese concept of clinical evaluation and clinical trial for medical device registration is unique, which is distinct from the clinical trial 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 do you conduct the clinical evaluation and clinical trial for your products exporting into the Chinese market?

To enter such a lucrative medical device market, overseas and multinational medical device manufacturers must have a comprehensive and thorough knowledge of the latest Chinese regulations on medical device clinical evaluation and clinical trial. Otherwise, the restrictive legal requirements and approval delays eat up your development time and budget.

Latest Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations on clinical evaluation and clinical trial for imported medical device registration but also introduced the practical operation how to comply with the Chinese GCP to guide you use the Chinese trial venues to keep medical device development lean and achieve a successful approval for your products entry into the Chinese medical device market.
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Chapter 1 Executive Summary.

Chapter 2 Latest Chinese Applicable Regulations for Clinical Evaluation and Clinical Trial of Medical Device Registration.

Chapter 3 What Chinese Regulations on Medical Device Registration are
Undergoing Radical Changes ---- A Comprehensive Comparative Analysis.
3.1. What Chinese Regulations on Imported Medical Device Registration are Undergoing Radical Changes?.
3.2. What Overseas Medical Devices Need to Conduct the Clinical Evaluation or Clinical Trial for Imported Medical Device Registration?.

Chapter 4 An Overview of Chinese Regulatory Authorities for Clinical Evaluation and Clinical Trial of Imported Medical Device 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 Knowledge Preparation before Conducting Clinical Evaluation and Clinical Trial for Imported Medical Device Registration.
5.1. Definitions.
5.2. Classified Administration for Registration and Recordation of Medical Devices.
5.3. What Medical devices may be exported into China?.
5.4. Regulations on Applicant or Filer for Imported Medical Device Registration or Recordation.
5.5. Product Technical Requirements.
5.6. Registration Tests.
5.7. Clinical Evaluation.

Chapter 6 Medical Device Classification.
6.1. Guidelines and Principles for Medical Device Classification.
6.1.1. Guidelines for Medical Device Classification.
6.1.2. Principles for Medical Device Classification.
6.2. Judgment Table for Medical Device Classification.
Table 6.2. Judgment Table for Medical Device Classification.

Chapter 7 Rights of Human Subjects and Every Party's Responsibilities in Clinical Trials for Imported Medical Devices.
7.1.Rights and Interests of Human Subject.
7.2.The Responsibilities for Implementer of Clinical Trials.
7.3. The Responsibilities for Clinical Trial Institutions and Personnel of Clinical Trials.

Chapter 8 Clinical Evaluation and Clinical Trial of Imported Medical Device Registration.

Chapter 9 Practical Guidance for Applying for Clinical Trials of Imported Medical Device Registration.
9.1. Application Form for Approval of Medical Device Clinical Trial.
Table 9.1. Application Form for Approval of Medical Device
Clinical Trial.
9.2. Requirements for Application Documents for Approval of Medical Device Clinical Trial.63
9.3. How to Compile the Product Technical Requirements.66
Table 9.3. Format of Product Technical Requirements of Medical Devices.
9.4. Notice of Medical Device Clinical Trials.
9.5. Clinical Trials Protocol and Format of Clinical Trial Protocol for Medical Devices.
Table 9.5. Format of Clinical Trial Protocol for Medical Devices.
9.6. How Many of Medical Devices need to Conduct Clinical Trial and Approval within Chinese territory.
Table 9.6. Catalogue of Class III Medical Devices Need to Clinical Trial Approval.
9.7. Submission of Application Documents.
9.8. Approval Document for Medical Device Clinical Trial.
Table 9.8. Approval Document for Medical Device Clinical Trial.

Chapter 10 Practical Guidance for Conducting Clinical Evaluation of Imported Medical Device Registration.
10.1. Requirements for Clinical Evaluation of Product listed into the Catalogue of Exempted Clinical Trial Medical Devices.
10.2. General Requirements for Conducting Clinical Evaluation by Comparation of Clinical Data of Medical Device with Same Varieties.
10.2.1. Basic Principles.
10.2.2. Comparison and Judgment of Clinical Data of Medical Device with Same Varieties.
10.2.3. Path of Evaluation.
10.2.4. Collection of Clinical Data for Medical Devices of Same Varieties.
10.2.5. Clinical Evaluation based on Clinical Data of Medical Devices of Same Varieties.
10.3. Requirements for Clinical Evaluation by Conducting Clinical Trials.
10.4. Practical Guidance for Conducting Clinical Evaluation of Imported Medical Device Registration.
10.4.1. Clinical Evaluation of Contrasting Product Applying for Registration with Products listed into the Catalogue of Exempted Clinical Trial Medical Devices.
Table 10.4.1. Contrast Table of Content between the product applying for registration and the product listed into the Catalogue of Exempted Clinical Trial Medical Devices.
10.4.2. Clinical Evaluation based on Clinical Data of Medical Devices with Same Varieties.
Table 10.4.2.1.Contrast Items and Conclusion Requirements for the product applying for registration comparing with the products of same varieties.
Table 10.4.2.2. Contrast Content between the product applying for registration and the products of same varieties.
Table 10.4.2.4. Path of Clinical Evaluation based on Clinical Data of Medical Devices with Same Varieties.
Annex 10.4.2.5. Proposed Essential Factors for Retrieve and Screen of Literatures.
Figure 10.4.2.5.Proposed Screening Process of Literatures.
Table 10.4.2. 6. Scheme of Retrieve and Screen of Literatures.
Table 10.4.2.7. Report of Retrieve and Screen of Literatures.
Table 10.4.2.8. Content and Format of Clinical Evaluation Report based on Clinical Data of Medical Devices of Same Varieties.

Chapter 11 Appendices.
Appendix 1 Regulations for the Supervision and Administration of Medical Devices (2014 Edition).
Appendix 2 Measures for the Administration of Medical Device Registration (2014 Edition).
Appendix 3 Regulations on the Administration of the Instructions and Labels of Medical Devices (2014 Edition).
Appendix 4 Rules for Medical Device Classification (2014 Edition).
Appendix 5 Provisions for Clinical Trials of Medical Devices.
Appendix 6 Technical Guidance Principles for Clinical Evaluation of Medical Devices.

Table 4.2.1. CFDA’s affiliated organizations.
Table 6.2. Judgment Table for Medical Device Classification.
Table 9.1. Application Form for Approval of Medical Device
Clinical Trial.
Table 9.3. Format of Product Technical Requirements of Medical Devices.
Table 9.5. Format of Clinical Trial Protocol for Medical Devices.
Table 9.6. Catalogue of Class III Medical Devices Need to Clinical Trial Approval.
Table 9.8. Approval Document for Medical Device Clinical Trial.
Table 10.4.1. Contrast Table of Content between the product applying for registration and the product listed into the Catalogue of Exempted Clinical Trial Medical Devices.
Table 10.4.2.1.Contrast Items and Conclusion Requirements for the product applying for registration comparing with the products of same varieties.
Table 10.4.2.2. Contrast Content between the product applying for registration and the products of same varieties.
Table 10.4.2.4. Path of Clinical Evaluation based on Clinical Data of Medical Devices with Same Varieties.
Table 10.4.2. 6. Scheme of Retrieve and Screen of Literatures.
Table 10.4.2.7. Report of Retrieve and Screen of Literatures.
Table 10.4.2.8. Content and Format of Clinical Evaluation Report based on Clinical Data of Medical Devices of Same Varieties.

Figure 4.2.1. CFDA’s Organizational Structure.
Figure 10.4.2.5.Proposed Screening Process of Literatures.
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Report Highlights

- An overview of the latest Chinese applicable regulations for clinical evaluation and clinical trial of medical device registration.

- A comprehensive comparative analysis ---- what Chinese regulations on medical device registration are undergoing radical changes.

- An overview of organizational structure of Chinese regulatory authorities for clinical evaluation and clinical trial of imported overseas medical devices registration to give the direction of gateway for application for approval of clinical trial for imported overseas medical device registration.

- The knowledge preparation before consucting the clinical evaluation and clinical trial for imported overseas medical device registration 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 detailed Chinese classification for medical devices.

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

- The unique Chinese regulations for clinical evaluation and clinical trial of imported overseas medical device registration to help overseas medical device manufacturers to remove their confusion.

- The practical guidance for applying for clinical trials of imported overseas medical device registration, from what imported overseas medical devices need to conduct clinical trial and approval within Chinese territory, how to apply for clinical trial of imported overseas medical device registration, how to compile the product technical requirements, how to compile application documents to how to acquire the approval document for clinical trial of imported overseas medical device registration to smoothly navigate complex regulatory requirements step by step.

- The practical guidance for conducting clinical evaluation of imported overseas medical device registration, also from what imported overseas medical devices need to conduct clinical evaluation of imported overseas medical device registration, what requirements are for conducting clinical evaluation of imported overseas medical device registration, how to conduct the clinical evaluation of imported overseas medical device registration to how to compile application documents to smoothly navigate complex regulatory requirements step by step.

- A complete set of full text in English of the latest Chinese applicable regulations for medical device clinical evaluation and clinical trial of imported overseas medical device registration, which include “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)”, “Rules for Medical Device Classification (2014 Edition)” , “Provisions for Clinical Trials of Medical Devices” and “Technical Guidance Principles for Clinical Evaluation of Medical Devices”.

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