China’s Guidebook for Application and Approval of Imported Medical Device Registration

Published : January 2012
No. of Pages : 154

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Report Summary

In 2009, the Chinese government vigorously launched China’s Health-Care Reform, developed an ambitious blueprint, in which health care system will cover about 1.2 billion people by 2011. Medical devices have been widely used in the process of disease prevention, diagnosis, therapy, care and rehabilitation. It is estimated that within the next few years, Chinese medical device market is likely to be more than 600 billion RMB, and will surpass Japan to become the second largest medical device market following the United States. The Chinese medical devices market will attract more and more medical devices produced by overseas manufacturers and producers to penetrate such market.

To enter Chinese lucrative medical device market, the first obstacle faced by overseas medical devices manufacturers and producers is how to file the application for their imported medical device registration with Chinese regulatory authorities for medical devices.

In China, the process of application and approval for imported medical device registration is very complex, because the Chinese regulatory authorities for medical devices administer and control this process by exorbitant administrative measures and regulations, moreover, these exorbitant administrative regulations are variable and lack of transparency. Lack of knowledge of the Chinese laws and administrative regulations, and the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas medical devices manufacturers and producers. Therefore, a detailed guidance of practical operation for application and approval of imported medical device registration and a comprehensive and thorough knowledge of the latest Chinese laws and regulations for imported medical device registration have been become an essential prerequisite for overseas medical devices manufacturers and producers to achieve a successful application for their products entry into the Chinese medical device market.

China’s Guidebook for Application and Approval of Imported Medical Device Registration is an essential resource for overseas medical devices manufacturers and producers to achieve a successful application for their products entry into the Chinese medical device market, which provides not only a detailed guidance of practical operation for application and approval of imported medical device registration but also comprehensive and thorough knowledge of the latest Chinese laws and regulations for imported medical device registration to guide overseas medical devices manufacturers and producers step by step to pass through the entirely legal procedures of application and approval for imported medical device registration smoothly.

Report Highlights

An overview of the main responsibilities and organization structure of the SFDA (The State Food and Drug Administration) that is current Chinese regulatory authority being responsible for application and approval for imported medical device registration.
A framework of latest applicable Chinese laws and regulations for imported medical device registration to provide a comprehensive and thorough knowledge of the latest Chinese laws and regulations for imported medical device registration.
The general regulations for application and approval of imported medical device registration to provide a guidance of practical operation for application and approval of imported medical device registration.
An overview of entire process of application and approval for imported medical device registration, including the procedures of the initial application and approval for imported medical device registration, the application and approval for imported medical devices re-registration.
The Chinese medical devices classification, including the guidelines and principles, and the criteria for medical devices classification.
The guidance of clinical trials for imported medical device registration.
The requirements for documents of application and approval for imported medical device registration to guide you prepare complex documents for application and approval for imported medical device registration.
The significant suggestions for overseas medical devices manufacturers and producers looking to achieve a successful application for their medical device registration in China.
The English versions of full latest Chinese administrative regulations and departmental regulations and provisions for medical device registration to facilitate overseas medical devices manufacturers and producers to acquire a comprehensive knowledge of latest applicable Chinese regulations for imported medical device registration, including the Regulations for the Supervision and Administration of Medical Devices, the Measures for the Administration of Medical Device Registration, the Regulations on the Administration of the Manuals, Labels and Packing Marks of Medical Devices, the Provisions for Clinical Trials of Medical Devices, and the Provisions for Medical Device Classification.

Who should buy this report?

Senior executive officers engaging in regulatory and registration affairs for medical device registration in China.
Non-Chinese Companies wishing to enter a lucrative medical device market in China.
Non-Chinese Companies interested in understanding the latest Chinese regulations on application and approval for imported medical device registration.
Non-Chinese medical devices manufacturers and producers.

Table of Contents

Preface 1

Table of Contents 3

Chapter 1 Executive Summary 6

Chapter 2 An Overview of Chinese Regulatory Authorities for Medical Devices -- State Food and Drug Administration (SFDA) 9
2.1. SFDA’s Main Responsibilities 9
2.2. SFDA’s Organization Structure 10
Figure 2.2. SFDA’s Organization Structure 11
Table 2.2. SFDA’s Affiliated Organizations 12

Chapter 3 Chinese Laws and Regulations for Imported Medical Device Registration 15
3.1. Chinese Legislation 15
3.2. Latest Applicable Administrative Regulations, and Departmental Regulations, Provisions, Measures, and Guidance 15

Chapter 4 General Regulations for Application and Approval of Imported Medical Device Registration 18
4.1. Definitions 18
4.2. Regulatory Authorities for Medical Devices 18
4.3. Classified Registration and Administration of Medical Devices 18
4.4. Medical Device Registration Certificate and its Valid Time Limitation 19
4.5.Application and Approval for Imported Medical Device Registration 19
4.5.1. Application and Approval for Initial Registration 19
4.5.2. Application and Approval for Re-registration 26
4.5.3. Modification and Re-issuance of Medical Device Registration Certificate 27

Chapter 5 Entire Process of Application and Approval for Imported Medical Device Registration 28
5.1. Process of Initial Application and Approval for Class II or III Imported Medical Device Registration 28
Figure 5.1. Process of Initial Application and Approval for Class II or III Imported Medical Device Registration 29
5.2. Process of initial Application and Approval for Class I Imported Medical Device Registration 30
Figure 5.2. Process of initial Application and Approval for Class I Imported Medical Device Registration 30
5.3. Process of Application and Approval for Class II or III Imported Medical Device Re-registration 30
Figure 5.3. Process of Application and Approval for Class II or III Imported Medical Device Re-registration 31
5.4. Process of Application and Approval for Class I Imported Medical Device Re-registration 31
Figure 5.4. Process of Application and Approval for Class I Imported Medical Device Re-registration 32

Chapter 6 Medical Device Classification 33
6.1. Guidelines and Principles for Medical Device Classification33
6.1.1. Guidelines for Medical Device Classification33
6.1.2. Principles for Medical Device Classification34
6.2. Criteria for Medical Device Classification35
Table 6.2 Criteria for Medical Device Classification36

Chapter 7 Clinical Trials of Medical Devices 39
7.1. Clinical Trial Requirements for Imported Medical Device Registration 39
7.2. Assurance of Rights and Interests of Human Subjects 40
7.3. Clinical Trials Protocol 41
7.4. Implementation of Clinical Trials 42
7.5. Medical Institutions and Personnel of Clinical Trials 43
7.6. Clinical Trials Report 43
7.7. Format of Clinical Trials Protocol for Medical Devices 44
7.8. Format of Clinical Trials Report for Medical Devices 48

Chapter 8 Documents for Application and Approval of Imported Medical Device Registration 51
8.1. Form of Medical Device Registration Record 52
8.2. Requirements on Application Documents for the Initial Registration of Imported Medical Devices .52
8.3. Requirements on Application Documents for the Re-registration of Imported Medical Devices 55
8.4. Requirements on Application Documents for the Initial Registration of Class I Imported Medical Devices without Foreign Sales License for Medical Devices 57
8.5. Requirements on Application Documents for the Initial Registration of Class II and III Imported Medical Devices without Foreign Sales License for Medical Devices 59
8.6. Requirements on Application Documents for the Modification of Medical Device Registration Certificate 61
8.7. Requirements on Application Documents for the Re-issuance of Medical Device Registration Certificate 63
8.8. Provisions on Itemization of Clinical Trial Documents for Medical Device Registration 64
Table 8.8. Provisions on Itemization of Clinical Trial Documents for Medical Device Registration 64

Chapter 9 Conclusion 69

Chapter 10 Appendices 74

Appendix 1 Regulations for the Supervision and Administration of Medical Devices 74

Appendix 2 Measures for the Administration of Medical Device Registration 90

Appendix 3 Regulations on the Administration of the Manuals, Labels and Packing Marks of Medical Devices 124

Appendix 4 Provisions for Clinical Trials of Medical Devices 128

Appendix 5 Provisions for Medical Device Classification 151

China’s Guidebook for Application and Approval of Imported Medical Device Registration

Published By: Access China Management Consulting Ltd

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