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Latest Guidebook for Chinese Special Examination and Approval Procedures for Innovative Medical Devices (2019 Edition): speed up overseas innovative medical devices entry into Chinese market

Report Summary:
Executive Summary

Facing a gigantic population and rapid population aging, China’s regulatory framework for medical devices is undergoing radical changes. In order to promote the implementation of a strategy of healthy China, transform the treating diseases as focal points into the people’s health as centre, prevent and control the major diseases, actively respond to the aging of the population and accelerate the development of aged healthcare service to give the populace with a full range and full-cycle health and medical services for lifetime, the Chinese “National Medical Products Administration (NMPA)” issued the latest modified version of “Special Examination and Approval Procedures for Innovative Medical Devices” on November 2, 2018, and implemented on December 1, 2018. Its aim is to encourage research and innovation of medical devices, promote the popularization and application of new technologies for medical devices to finally meet the growing medical care needs.

Chinese special examination and approval procedures for innovative medical devices established a fast-track approval path and an interactive mechanism between the Chinese drug regulatory authorities and the applicant for innovative medical devices, which reduces risk from the review uncertainty and approval delays that avoid to exhaust applicant's time and energy. This fast-track approval path and an interactive mechanism between the Chinese drug regulatory authorities and the applicant for innovative medical devices offer a huge business opportunity for the foreign medical device manufacturers to achieve a successful entry into Chinese healthcare market and smoothly operate their business in China.

How to grasp the opportunity to speed up your innovative medical device product approval? The overseas and multinational medical device manufacturers must have a comprehensive knowledge of the Chinese special examination and approval procedures for innovative medical devices.The Chinese regulatory approach is unique.

“Latest Guidebook for Chinese Special Examination and Approval Procedures for Innovative Medical Devices (2019 Edition): speed up overseas innovative medical devices entry into Chinese market” provided a comprehensive knowledge of the latest Chinese special examination and approval procedures for innovative medical devices to guide your practical operation how to comply with the Chinese regulations.

The organizations of this guidebook are arranged as follows. Chapter 2 introduces what innovative medical devices are applicable to Chinese special examination and approval procedures. Chapter 3 introduces who are the Chinese regulatory authorities for special examination and approval of overseas innovative medical devices. Chapter 4 elaborates the special regulations for overseas applicant. Chapter 5 introduces how many application dossiers for an oversea innovative medical device should be prepared. Chapter 6 provides the practical guidance for application of special examination and approval procedures of overseas innovative medical devices. Chapter 7 elaborates the benefits from special examination and approval procedures of innovative medical devices: priority processing and interactive mechanism. Chapter 8 conclusions give significant suggestions for overseas and multinational medical device manufacturers to acquire the qualifications of special examination and approval procedures for overseas innovative medical devices. Chapter 9 appendices provide a full set of the English and Chinese bilingual forms relating to the overseas applicant applying for special examination and approval procedures of overseas imported innovative medical device and information communication and exchange of overseas imported innovative medical device with the Chinese drug regulatory authorities, and the feedback letter from the Chinese drug regulatory authorities.

The audiences of this guidebook are overseas medical device manufacturers wishing to enter into the Chinese medical device market, and multinational medical device companies have penetrated into the Chinese medical device market, and their senior executive officers engaging in regulatory affairs expecting to understand how to apply for registration of their medical device products in China and how to comply with the latest Chinese regulations for medical device registration.

After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive knowledge of the latest Chinese special examination and approval of overseas innovative medical devices but also the practical operation how to comply with the latest Chinese special examination and approval of overseas innovative medical devices. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas and multinational medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market and smoothly operate their products in China.

Major Market Players:

Reasons To Buy
The Chinese “National Medical Products Administration (NMPA)” issued the latest “Special Examination and Approval Procedures for Innovative Medical Devices” on November 2, 2018, and implemented on December 1, 2018. Chinese special examination and approval procedures for innovative medical devices established a fast-track approval path and an interactive mechanism between the Chinese drug regulatory authorities and the applicant for innovative medical devices, which reduces risk from the review uncertainty and approval delays that avoid to exhaust applicant's time and energy. This fast-track approval path and an interactive mechanism between the Chinese drug regulatory authorities and the applicant for innovative medical devices offer a huge business opportunity for the foreign medical device manufacturers to achieve a successful entry into Chinese healthcare market and smoothly operate their business in China. How to grasp the opportunity to speed up your innovative medical device product approval? The overseas and multinational medical device manufacturers must have a comprehensive knowledge of the Chinese special examination and approval procedures for innovative medical devices. The Chinese regulatory approach is unique.
“Latest Guidebook for Chinese Special Examination and Approval Procedures for Innovative Medical Devices (2019 Edition): speed up overseas innovative medical devices entry into Chinese market” provided a comprehensive knowledge of the latest Chinese special examination and approval procedures for innovative medical devices to guide your practical operation how to comply with the Chinese regulations. It is an essential resource for overseas and multinational medical device manufacturers to speed up overseas innovative medical devices entry into Chinese market, which provides not only a comprehensive knowledge of the latest Chinese special examination and approval procedures for innovative medical devices but also the practical operation how comply with the latest Chinese regulations to smoothly navigate complex regulatory requirements.


Report Highlights
—What overseas imported innovative medical devices are applicable to Chinese special examination and approval procedures?
—Who are the Chinese regulatory authorities for special examination and approval of overseas imported innovative medical devices?
—The Chinese special regulations for overseas applicant.
—How many application dossiers for special examination and approval procedures of an oversea imported innovative medical device should be prepared?
—The detailed practical guidance for application of special examination and approval procedures of overseas imported innovative medical devices to smoothly navigate complex regulatory requirements.
—What are the benefits from Special Examination and Approval of Innovative Medical Devices: Priority Processing and Interactive Mechanism.
—The significant suggestions for overseas and multinational medical device manufacturers to acquire the qualifications of special examination and approval procedures for overseas imported innovative medical devices.
—A full set of the English and Chinese bilingual forms relating to the overseas applicant applying for special examination and approval procedures of overseas imported innovative medical device and information communication and exchange of overseas imported innovative medical device with the Chinese drug regulatory authorities, and the feedback letter from the Chinese drug regulatory authorities.

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Contents.

Chapter 1 Executive Summary

Chapter 2 What Innovative Medical Devices are Applicable to Chinese Special Examination and Approval Procedures

Chapter 3 Who are Chinese Regulatory Authorities for Special Examination and Approval of Overseas Innovative Medical Devices

Chapter 4 Special Regulations for Overseas Applicant

Chapter 5 How Many Application Dossiers for Oversea Innovative Medical Device should be Prepared
5.1. Content Requirements for Application Materials
5.2. Format Requirements for Application Materials
5.3 Other Special Requirements for Application Materials

Chapter 6 Practical Guidance for Application of Special Examination and Approval Procedures of Overseas Imported Innovative Medical Devices
Figure 1 Application Process for Special Examination and Approval Procedures of Overseas Imported Innovative Medical Device
Figure 2 Application Process for Communication and Exchange of Overseas Imported Innovative Medical Device

Chapter 7 What are the benefits from Special Examination and Approval Procedures of Innovative Medical Devices: Priority Processing and Interactive Mechanism
Figure 3. Overview of the Benefits of Special Examination and Approval Procedures for Overseas Imported Innovative Medical Devices

Chapter 8 Conclusion: Sincere Advice

Chapter 9 Appendices
Annex 1 Application Form for Special Examination and Approval of Innovative Medical Device
Annex 2 Application Form for Information Communication and Exchange of Innovative Medical Device
Annex 3 Feedback Letter for Application of Information Communication and Exchange of Innovative Medical Device

Research Process

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

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.

ANALYSIS

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.

MARKET ESTIMATION

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.