In recent years, China’s healthcare market landscape and regulatory framework is undergoing rapid changes. Facing a gigantic population and rapid population aging as well as growing medical care demand, the Chinese government, on one side, accelerated the priority approval of innovative drugs and medical devices and relaxed the market access for overseas drugs and medical devices, on other side, intensified the supervision and administration for drugs and medical devices on the post—marketed and the marketing authorization approval.
In January 2018, predecessor of the National Medical Products Administration (NMPA), China Food and Drug Administration (CFDA) issued the “Technical Guideline for Accepting Overseas Clinical Trial Data of Medical Devices” to attempt speeding up marketing authorization approval for overseas medical devices in China. At present, National Medical Products Administration (NMPA) is firmly enforcing this Guideline. Indubitably, this is an opportunity that the foreign medical device manufacturers let their medical devices successful entry the Chinese healthcare market. However, the Guideline clearly stated that overseas clinical trial data should not only comply with the ethical principles, legal principles and scientific principles but also the China’s GCP for Medical Devices. The Guideline elaborated the Chinese Drug Regulatory Authority on the considering factors and technical requirements for accepting overseas clinical trial data from the aspects of technical review requirements, differences of trial population and clinical trial conditions. In fact, during in the process of granting marketing authorization approval for overseas medical devices in China, not only the overseas clinical trial data of medical devices submitted by the overseas medical device manufacturer should comply with the China’s GCP for Medical Devices, but also the overseas medical device manufacturer should designate an agency with legal person status within the territory of China or its representative office stationed in China to act as its agent to apply for communication and exchange with the Center for Medical Device Evaluation of NMPA (hereinafter called as CMDE). If the overseas medical device manufacturer can reach a consensus with the CMDE on overseas clinical trial data of medical devices submitted, then the overseas medical device manufacturer has got half the results for marketing authorization approval. All these efforts, however, must be established on base complying with the China’s GCP for Medical Devices and the considering factors and technical requirements for overseas clinical trial data by Chinese Drug Regulatory Authority.
Chinese regulatory approach is unique, which is different from that of US-EU. Chinese Drug Regulatory Authority administers and controls over this procedure of granting marketing authorization approval for overseas medical devices by exorbitant administrative measures and complex regulations. Moreover, the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas medical device manufacturers. As a result, in order to smoothly pass this procedure of granting marketing authorization approval by submitted the overseas clinical trial data of medical devices, the overseas medical device manufacturers and their senior executive officers engaging in regulatory affairs need a comprehensive and thorough knowledge of China’s GCP for Medical Devices.
Key HighLights
A comprehensive knowledge of the latest China’s Good Clinical Practice (GCP) for Medical Devices, from the general regulations, preparation before clinical trial, guarantee of rights and interests of subjects, clinical trial protocol, responsibilities of ethics committee, responsibilities of sponsor, responsibilities of clinical trial institutions and investigators, records and reports, management of investigational medical devices, management of basic documents to the inspection key points for medical device clinical trials and principles of judgment in compliance with China's GCP for Medical Devices to navigate China’s Medical Device Good Clinical Practice (GCP) with article by article and clause by clause. A comprehensive knowledge of the latest China’s Good Clinical Practice (GCP) for Medical Devices let the overseas medical device manufacturers lay a solid foundation of knowledge for using overseas clinical trial data to apply for marketing authorization for overseas medical devices in China.
Why should you 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.
• Senior executive officers engaging in regulatory affairs expecting to understand how to use the overseas clinical trial data to apply for marketing authorization in China for their overseas medical devices,
• Senior executive officers engaging in regulatory affairs expecting to understand how to apply for clinical trials for their overseas medical devices in China, and how to comply with the latest Chinese GCP for Medical Devices to successfully apply for marketing authorization in China for their overseas medical devices.
Chapter 1 Executive Summary.
Part One China’s Good Clinical Practice (GCP) for Medical Devices.
Chapter 2 General Regulations.
2.1. General Regulations.
2.2. Definitions.
Chapter 3 Preparation before Clinical Trial.
Chapter 4 Guarantee of Rights and Interests of Subjects.16
Chapter 5 Clinical Trial Protocol.22
Chapter 6 Responsibilities of Ethics Committee.24
Chapter 7 Responsibilities of Sponsor.28
Chapter 8 Responsibilities of Clinical Trial Institutions and Investigators.34
Chapter 9 Records and Reports.39
Chapter 10 Management of Investigational Medical Devices .42
Chapter 11 Management of Basic Documents.43
Chapter 12 Inspection Key Points for Medical Device Clinical Trials and Principles of Judgment in Compliance with China's GCP for Medical Devices.44
12.1. Inspection Key Points and Content for Medical Device Clinical Trials.45
Table 12.1. Inspection Key Points and Content for Medical Device Clinical Trials.45
12.2. Principles of Judgment in Compliance with China's GCP for Medical Devices.56
Part Two Guidance of Practical Operation for Using Overseas Clinical Trial Data to Apply for Marketing Authorization in China.58
Chapter 13 Chinese Drug Regulatory Authority on Special Regulations for Overseas Medical Device Manufacturers.58
Chapter 14 Chinese Drug Regulatory Authority on Basic Principles for Accepting Overseas Clinical Trial Data for Medical Devices.60
Chapter 15 Chinese Drug Regulatory Authority on Criteria for Accepting Overseas Clinical Trial Data for Medical Devices.62
Chapter 16 Chinese Drug Regulatory Authority on Considered Factors and Technical Requirements for Accepting Overseas Clinical Trial Data for Medical Devices.64
Chapter 17 How Overseas Applicants Apply for an Interactive Mechanism of Communication and Exchange with the CMDE.67
Chapter 18 How Overseas Applicants Communicate and Exchange with the CMDE to Conclude the Minutes of Communication and Exchange Meeting.70
Part Three Appendices.75
Chapter 19 Form and Document Text relating to Communication and Exchange between the Overseas Applicant and the CMDE.75
Annex 1 Application Form of Communication and Exchange Meeting for Pre-Clinical Trial Approval Application.75
Annex 2 Communication and Exchange Meeting Minutes Template.77
Chapter 20 Exemplary Document Texts relating to China’s GCP for Medical Devices.79
Annex 3 Exemplary Text of Ethical Review and Approval Form of Application for Medical Device Clinical Trial.80
Annex 4 Exemplary Text of Informed Consent Form.86
Annex 5 Exemplary Text of Case Report Form for Medical Device Clinical Trial.92
Annex 6 Exemplary Text of Clinical Trial Protocol.98
Annex 7 Exemplary Text of Clinical Trial Report.109
Annex 8 Basic Document Directory for Clinical Trial of Medical Device that must be Preserved.115
Annex 1 Application Form of Communication and Exchange Meeting for Pre-Clinical Trial Approval Application
Annex 2 Communication and Exchange Meeting Minutes Template.
Annex 3 Exemplary Text of Ethical Review and Approval Form of Application for Medical Device Clinical Trial
Annex 4 Exemplary Text of Informed Consent Form
Annex 5 Exemplary Text of Case Report Form for Medical Device Clinical Trial
Annex 6 Exemplary Text of Clinical Trial Protocol
Annex 8 Basic Document Directory for Clinical Trial of Medical Device that must be Preserved
Table 12.1. Inspection Key Points and Content for Medical Device Clinical Trials.
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