2022Navi Mumbai, October 16, 2014 -- /EPR NETWORK/ -- Bharat Book Bureau presents the new report, on "Latest Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices (2014 Edition)". The report highlight the 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.
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.
Executive Summary
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.
Reasons To Buy
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.
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 conducting 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.
Table of contents
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
Chapter 4 An Overview of Chinese Regulatory Authorities for Clinical Evaluation and Clinical Trial of Imported Medical Device Registration.
Chapter 5 Knowledge Preparation before Conducting Clinical Evaluation and Clinical Trial for Imported Medical Device Registration.
Chapter 6 Medical Device Classification.
Chapter 7 Rights of Human Subjects and Every Party's Responsibilities in Clinical Trials for Imported Medical Devices.
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.
Chapter 10 Practical Guidance for Conducting Clinical Evaluation of Imported Medical Device Registration.
List of Tables
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.
List of Figures
Figure 4.2.1. CFDA’s Organizational Structure.
Figure 10.4.2.5.Proposed Screening Process of Literatures.
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