Chapter 1 Executive Summary.4
Part One China’s Good Clinical Practice (GCP) for Medical Devices.8
Chapter 2 General Regulations.9
2.1. General Regulations.9
Chapter 3 Preparation before Clinical Trial.15
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
The research starts with the extensive procurement process of data/information and statistics from company annual reports, government websites, statistic agencies, and paid databases. This information creates a base for the study. This information also helps to define the scope and to narrow down the area for study for the market. This raw information is processed and analysed to extract crisp data points which currently affect or are likely to affect the industry over the forecast period. After analysing the information, a proprietary market estimation & forecast technique is applied, which generates the quantitative figures/sizes of the market/sub-segments in the current scenario as well as for over the forecast period. After populating the market sizes & estimates, numbers are verified with the industry participants and key opinion leaders. The wide network of industry participants performs a value addition in the research and verify the numbers & estimates of the study. In the last stage of the research process, a final report is prepared which is then published on different websites as well as distributed through various channels. Below figure contains the different stages of the whole research performed to produce the report.
After populating the market sizes & estimates, numbers are verified with the industry participants and key opinion leaders. The wide network of industry participants performs a value addition in the research and verify the numbers & estimates of the study. In the last stage of the research process, a final report is prepared which is then published on different websites as well as distributed through various channels. Below figure contains the different stages of the whole research performed to produce the report.
Data mining is one of the extensive stages of our research process. It involves the procurement of market data and related information through different verified & credible sources. This step helps to obtain the raw information about the supply chain of the industry, the monetary process of different Products & End-Uses, the pool of market participants & the nature of the industry and the scope of the study. The data mining stage comprises both primary as well as secondary sources of information. Some of the key data sources are as follows:
Secondary Research In the process of secondary research, various sources are referred to identify and collect industry trends and information for the research process. We at having access to some of the most diversified and extensive paid databases which give us the most accurate data/information on markets sizes, Products and pricing.
In the primary research process for data mining, various key industry participants from both supply and demand side are interviewed to obtain both qualitative as well as quantitative information on the market. In-depth interviews with key primary respondents, including industry professionals, subject matter experts (SMEs), industry consultants, and C-level executives of major companies are conducted to obtain critical qualitative and quantitative aspects pertaining to the market, as well as to assess the prospects for market growth over the forecast period.
This step involves the analysis & mapping of all the information procured from the previous step. This step also encompasses the scrutiny of data discrepancies observed across various data sources and finalising the appropriate data for estimation and forecasting. This analysis is done by our experienced panel of industry analysts.
Understanding and penetrating the market in terms of valuation is a crucial task in the process of business research. This again becomes significantly important while investing and choosing the business opportunities. In this regard, we perform two ways market sizing approach simultaneously namely top-down and bottom-up approaches. In this step, we place different data points, numeric attributes, information, and industry trends at an appropriate space in order to deduce the estimates & forecast values over the coming years. We use different mathematical models to estimate the market sizes of different economies and segments. Each of which is further summed up to define the total market. We own a proprietary tool for market estimations which helps us to comprehend market size estimates & forecasts for different markets and industries. Below figure explains the process of market estimation using independent tool employed by our analysts to get the sizing off the market.