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.
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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
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
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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. CFDAs Main Responsibilities.17
4.2. CFDAs 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
6.2. 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
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