Table of Contents
Chapter 1 Executive Summary. 3
Chapter 2 China’s Healthcare Market Landscape and Rapidly Changing
Regulatory Framework: Opportunities and Challenges for Overseas and Multinational Pharmaceutical and Medical Device Manufacturers.6
2.1. China’s Healthcare Market Landscape.6
2.2. What is cause to drive the regulatory framework rapid Change?.7
Chapter 3 General Regulations for Medical Device Adverse Event Reporting, Monitoring and Re-evaluation.11
3.1.1. Medical Device Marketing Authorization Holders.12
3.1.2. Medical Device Adverse Event.12
3.1.3. Serious Injuries.12
3.1.4. Medical Device Group Adverse Event.12
3.1.5. Medical Device Adverse Event Monitoring.12
3.1.6. Key Monitoring of Medical Devices.12
3.1.7. Re-evaluation of Medical Devices.13
3.1.8. User Facilities.13
3.1.9. Medical and Health Institutions.13
3.1.10. Medical Device Registration and Recordation.13
3.2. General Regulations for Medical Device Adverse Event Reporting, Monitoring and Re-evaluation.13
Chapter 4 Regulatory Authorities and their Functions.14
4.1. Medical Device Adverse Event Monitoring Information Network.14
4.2. Regulatory Authorities’ Duties and Obligations.16
Chapter 5 MA Holders’ Duties and Obligations.18
Chapter 6 Medical Device Distributors’ and Medical Device User Facilities’ Duties and Obligations.19
Chapter 7 Medical Device Adverse Event Reporting and Evaluation.20
7.1. Basic Requirements.20
7.2. Medical Device Adverse Event Reporting.23
7.2.1. Individual Case Adverse Event Reporting.23
7.2.2. Group Adverse Event Reporting.25
7.2.3. Periodic Risk Assessment Reporting.28
7.3. An Entire Process of Medical Device Adverse Event Reporting for
Figure 7.3. An Entire Process of Medical Device Adverse Event Reporting for MA Holder.31
Chapter 8 Key Monitoring.32
Chapter 9 Control of Risk.33
Chapter 10 Re-Evaluation.36
Chapter 11 Supervision and Inspection.39
Chapter 12 An Overview of Chinese Monitoring Network for Medical Device Adverse Event Reporting and Monitoring.41
Figure 12.1.An Overview of Chinese Monitoring Network for Medical Device Adverse Event Reporting and monitoring.43
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.