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Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices

Category : Medical Devices  | Published Date : Aug-2014 | Pages : 194
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Synopsis

Now, Chinese regulations on medical devices are undergoing earthshaking changes. Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration:From Regulations to Practices 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.

Summary

Now, Chinese regulations on medical devices are undergoing earthshaking changes. China’s new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid economic and population growth over the pasted three decades. Chinese state council issued the latest “Regulations for the Supervision and Administration of Medical Devices”  to try to completely change such imperfect status. China Food and Drug Administration issued the latest “Measures for the Administration of Medical Device Registration”, “Regulations on the Administration of the Instructions and Labels of Medical Devices”, “Measures for the Supervision and Administration of Medical Device Production”, “Measures for the Supervision and Administration of Medical Device Distribution” and “Measures for the Administration of IVD registration” on July 30, 2014 respectively, and they will come into force as October 1, 2014. The radical change of regulations on medical devices, especially for the latest “Measures for the Administration of Medical Device Registration” will bring overseas and multinational medical device manufacturers the maximum challenges and opportunities.

Those medical devices have not been granted the certificate of marketing authorization of medical device issued by the government authorities of the country or region of origin will be intercepted outside the door of Chinese medical device market. 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 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.

Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices 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.

The organizations of this guidebook are arranged as follows. Chapter 2 provides the analysis and research for radical change of Chinese regulations on medical devices. Chapter 3 introduces the framework of the latest applicable Chinese regulations for medical device registration to provide a comprehensive and thorough knowledge of the latest Chinese regulations for medical device registration. Chapter 4 provides an overview of the Chinese regulatory authorities - China Food and Drug Administration (CFDA) being responsible for application and approval for imported overseas medical device registration and recordation to give the direction of gateway for imported overseas medical devices registration and recordation. Chapter 5 elaborates the knowledge preparation before application of 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. Chapter 6 elaborates the medical device classification to let overseas medical device manufacturer understand the Chinese medical device classification, because the imported overseas medical device registration must be in compliance with such classification of medical devices. Chapter 7 introduces the rights of human subjects and every party’s responsibilities in clinical trials for imported overseas medical devices in China. Chapter 8 introduces the regulations for application for imported medical device recordation, which is applicable to Class I imported overseas medical devices. Chapter 9 provides the regulations for application and approval for imported medical device registration, which is applicable to Class II and II imported overseas medical devices. Chapter 10 introduces the regulations for application and approval for alteration registration of imported overseas medical devices. Chapter 11 introduces the regulations for renewal registration of imported overseas medical devices. Chapter 12 introduces the regulations for supervision and administration for application and approval of imported overseas medical device registration. Chapter 13 provides 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. Chapter 14 provides the practical guidance for application and approval of imported overseas medical device registration, 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. Chapter 15 provides 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. Chapter 16 Appendices provide a complete set of full text in English of the latest Chinese regulations involving with the imported overseas medical device registration

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 of their medical device products in China, how to comply with the latest Chinese regulations for medical device 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 medical device 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 medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market, and smoothly operate their products in China.

Scope

The latest Chinese regulations for imported medical device registration and 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.

Reasons To Buy

  • Now, Chinese regulations on medical devices are undergoing earthshaking changes. Those medical devices have not been granted the certificate of marketing authorization of medical device issued by the government authorities of the country or region of origin will be intercepted outside the door of Chinese medical device market. 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 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.
  • Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration:From Regulations to Practices 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.

Who should buy this report?

  • Overseas medical device manufacturers wishing to enter into the Chinese medical device market.
  • Multinational medical device manufacturers have penetrated into the Chinese medical device market.
  • Companies interested in understanding the latest Chinese laws and regulations for medical device product clinical trials.
  • Senior executive officers engaging in regulatory affairs for exporting medical devices into Chinese lucrative medical device market.
  • Senior executive officers engaging in conducting clinical trials for exporting medical devices into Chinese lucrative medical device market.

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 lates Chinese regulations for application for imported medical device recordation, which is applicable to Class I imported overseas medical devices.
  • The lates 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”, “Measures for the Administration of Medical Device Registration”, “Regulations on the Administration of the Instructions and Labels of Medical Devices”, “Provisions for Clinical Trials of Medical Devices”, and “Rules for Medical Device Classification”.

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
4.3. Roadmap of Application and Approval for Imported Medical Device Registration 25

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

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
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
13.2. Application for Alteration Recordation of Imported Medical Device 78
13.2.1. Form of Recordation Information 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
14.2. List of Registration Documents and Requirements for Registration Documents 93
14.3. How to Compile the Product Technical Requirements 99
14.4. How to Conduct the Clinical Trials for Medical Device 103
14.4.1. Application Form for Medical Device Clinical Trial 104
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
14.4.4. Clinical Trial Report and Format of Clinical Trial Report for Medical Devices 116
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

List of Tables

Table 4.2.1. CFDA’s affiliated organizations 21
Table 6.2. Judgment Table for Medical Device Classification 42
Table 13.1.1 . Recordation Form of Class I Medical Device 67
Table 13.1.5. Recordation Certificate 77
Table 13.2.1. Form of Recordation Information of Class I Medical Device 79
Table 14.1. Application Form for Registration of Imported Medical Device 86
Table 14.3. Format Requirements for Product Technical Requirements of Medical Devices 102
Table 14.4.1. Application Form for Medical Device Clinical Trial 105
Table 14.4.3. Format of Clinical Trial Protocol for Medical Devices 111
Table 14.4.4. Format of Clinical Trial Report for Medical Device 117

List of Figures

Figure 4.2.1. CFDA’s Organizational Structure 20
Figure 4.3.1. Roadmap of Examination and Approval for Imported Overseas Medical Device Registration 27

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Publisher Name : Access China Management Consulting Ltd

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