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Latest Guidebook for China’s Good Clinical Practice (GCP) for Medical Devices: How to Use Overseas Clinical Trial Data to Apply for Marketing Authorization in China (2019 Edition)

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.

The aim of this Guidebook is to guide the overseas medical device manufacturers how to acquire a comprehensive and thorough knowledge of China’s GCP for Medical Devices, and how to use the overseas clinical trial data to apply for marketing authorization in China for overseas medical devices.

“Latest Guidebook for China’s Good Clinical Practice (GCP) for Medical Devices: How to Use Overseas Clinical Trial Data to Apply for Marketing Authorization in China” is an essential resource for overseas medical device manufacturers to use overseas clinical trial data to successfully apply for marketing authorization in China for overseas medical devices, which provided not only a comprehensive knowledge of the latest Chinese GCP for Medical Devices, but also a detailed guidance of practical operation how use overseas clinical trial data to apply for marketing authorization in China for overseas medical devices, and in compliance with the Chinese Drug Regulatory Authority on the considering factors and technical requirements for overseas clinical trial data, including how establish an interactive mechanism between the overseas medical device manufacturers and the CMDE to reduce risk from the review uncertainty and approval delays that avoid to exhaust overseas applicant's time and energy.

This Guidebook is composed of three parts. The organizations of this guidebook are arranged as follows. Part One China’s Good Clinical Practice for Medical Devices. Chapter 2 introduces the general regulations of the Chinese GCP for medical devices. Chapter 3 elaborates the preparation before clinical trial. Chapter 4 expounds the guarantee of rights and interests of subjects. Chapter 5 expounds the clinical trial protocol. Chapter 6 elaborates the responsibilities of ethics committee. Chapter 7 elaborates the responsibilities of sponsor. Chapter 8 elaborates the responsibilities of clinical trial institutions and investigators. Chapter 9 expounds the records and reports for clinical trial. Chapter 10 expounds the management of investigational medical devices for clinical trial. Chapter 11 expounds the management of basic documents for clinical trial. Chapter 12 elaborates the inspection key points for medical device clinical trial and the principles of judgment in compliance with the Chinese GCP for medical devices. Part Two Guidance of Practical Operation for Using Overseas Clinical Trial Data to Apply for Marketing Authorization in China. Chapter 13 elaborates the Chinese Drug Regulatory Authority on special regulations for overseas medical device manufacturers. Chapter 14 expounds the Chinese Drug Regulatory Authority on basic principles for accepting overseas clinical trial data. Chapter 15 expounds the Chinese Drug Regulatory Authority on criteria for accepting overseas clinical trial data. Chapter 16 expounds the Chinese Drug Regulatory Authority on the considering factors and technical requirements for accepting overseas clinical trial data. Chapter 17 elaborates how overseas medical device manufacturers apply for an interactive mechanism of communication and exchange with the CMDE. Chapter 18 elaborates how overseas medical device manufacturers communicate and exchange with the CMDE to reach the minutes of the communication and exchange meeting. Part Three Appendices including a full set of the English and Chinese bilingual application forms that are stipulated by the Center for Medical Device Evaluation (CMDE) of NMPA, and a full set of the English and Chinese bilingual exemplary document texts that are stipulated by the Chinese Drug Regulatory Authority, which are the essential documents to support China's GCP for Medical Devices. Chapter 19 Form and Document Text relating to the communication and exchange between the overseas medical device manufacturer and the CMDE, including the "Application Form of Communication and Exchange Meeting for Pre-Clinical Trial Approval Application” and “Template of Minutes for Communication and Exchange Meeting”. Chapter 20 Exemplary Document Texts relating to China’s GCP for Medical Devices, including the “Ethical Review and Approval Form of Application for Medical Device Clinical Trial”, “Text of Informed Consent Form”, “Text of Case Report Form for Medical Device Clinical Trial”, “Text of Clinical Trial Protocol for Medical Device”, “Text of Clinical Trial Report of Medical Device”, and “Basic Document Directory for Clinical Trial of Medical Device that must be Preserved”.

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 use the overseas clinical trial data to apply for marketing authorization in China for their overseas medical devices, 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.

After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive knowledge of the latest Chinese GCP for Medical Devices but also the guidance of practical operation how to use the overseas clinical trial data to apply for marketing authorization in China for their overseas 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 business in China.

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Contents.1
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
2.2. Definitions.10
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

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.