Request for Sample

Latest guidebook for Chinese Medical Device Recall Regulations (2019 Edition)

Report Summary:
China is one of the fastest growing global economies with one fifth population in the world. Nowadays, China has become the world's second largest healthcare market after the United States. 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 government, on one side, accelerated the priority approval of innovative medical devices and relaxed the market access for overseas medical devices, on other side, intensified the supervision and administration for medical devices on the post—market. In China, today medical devices have been widely used in the process of disease prevention, diagnosis, therapy, care and rehabilitation. However, large and medium-sized medical devices, high-end medical equipments and high-value medical materials are mainly relying on imported, such as the high-tech and high-valued imaging systems and navigation and positioning systems. In which the high-end and high-value medical devices are almost monopolized by GE, Siemens, Philips and other overseas and multinational companies. If you search on website of the Chinese regulatory authority--“National Medical Products Administration (NMPA)”, you may find there are many announcements of medical devices recall for those that made by overseas and multinational medical device manufacturers, because the overseas imported medical devices account for about half of the high-tech and high-valued products in Chinese medical device market. In order to meet the growing medical needs and ensure the safety of the people, the predecessor of the National Medical Products Administration (NMPA), China Food and Drug Administration (CFDA) issued the latest modified version of “Administrative Measures on Medical Device Recall” on January 25, 2017, which has been implemented on May 1, 2017. At present, National Medical Products Administration (NMPA) is firmly enforcing the “Administrative Measures on Medical Device Recall”. How do the overseas medical device manufacturers handle an overseas imported medical device recall smoothly in China? When is recall reporting voluntary vs. mandatory? What are characteristics and strategy of the recall that the overseas medical device manufacturers must consider when making the recall determination? How do the overseas medical device manufacturers comply with the Chinese latest medical device recall regulations? How do the overseas medical device manufacturers operate business smoothly in China? The overseas and multinational medical device manufacturers and their senior executive officers engaging in regulatory affairs need a comprehensive and thorough knowledge of the Chinese latest regulations on medical device recall. Otherwise the overseas and multinational medical device manufacturers and their imported medical devices would lose a huge medical device market in China. The regulations on medical device recall between China and US-EU are different. Moreover, the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas and multinational medical device manufacturers.

Latest guidebook for Chinese Medical Device Recall Regulations (2019 Edition) is an essential resource for overseas and multinational medical device manufacturers to handle a medical device recall smoothly in China, which provides not only a comprehensive knowledge of the Chinese latest medical device recall regulations, but also a detailed practical guidance for the overseas and multinational medical device manufacturers to handle an overseas imported medical device recall smoothly in China.

The organizations of this guidebook are arranged as follows. Chapter 2 provides the organizational structure of Chinese regulatory authorities for medical device recall. Chapter 3 provides the Chinese special regulations for overseas medical device manufacturers. Chapter 4 provides the general regulations for medical device recall, which cover the definitions relating to medical device recall, the practical guidance for who, where and how to submit medical device recall report, the investigation and evaluation of medical device defects, the classification for medical device recall, as well as information release for recalled medical device. Chapter 5 introduces the detailed regulations for voluntary recall of medical device, from the time limits of recall notifying, the indispensable content of the recall notification, the investigation and evaluation report, the recall plan, the periodical recall implementation report, disposal of recalled medical device to the recall summary report for terminating recall to guide you smoothly complete the recall, as well as a panoramic view of entire process of voluntary recall of medical device to let you understand at a glance. Chapter 6 elaborates the mandatory recall of medical device, which covering how would trigger a mandatory recall of medical device, what the contents of recall order issued by the drug regulatory authorities will be contained, how the medical device manufacturer copes with a mandatory recall of medical device, and how to handle a mandatory recall of medical device smoothly in China, as well as a panoramic view of entire process of mandatory recall of medical device exhibited also to let you understand at a glance. Chapter 7 introduces the detailed legal liabilities for the medical device manufacturers, the marketing or distributing enterprises and the user facilities of medical devices, and the drug regulatory authorities and their staff for a medical device recall. Chapter 8 introduces the remedy for patient. Chapter 9 introduces two typical cases of overseas imported medical device recall to expose practical operation. Chapter 10 provides a full set of the English and Chinese bilingual forms that are stipulated by the National Medical Products Administration (NMPA) to facilitate for you to operate them.

The audiences of this guidebook are overseas medical device manufacturers wishing to enter into the Chinese medical device market, and multinational medical device manufacturers have penetrated into the Chinese medical device market, and their senior executive officers engaging in regulatory affairs expecting to understand the Chinese latest medical device recall regulations. After have skimmed through this guidebook, audiences can clearly acquire a comprehensive and thorough knowledge of the Chinese latest medical device recall regulations. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas and multinational medical device manufacturers to achieve a successful entry into the Chinese medical device market, and smoothly operate their business in China.

Major Market Players:
GE Ultrasound Korea Ltd.
GE Medical Systems Trade & Development (Shanghai) Co. Ltd.
Medtronic Navigation Inc.
Medtronic (Shanghai) Management Co. Ltd.

Reasons To Buy
The Chinese regulatory authority has enacted the latest modified version of “Administrative Measures on Medical Device Recall” on January 25, 2017, which has been implemented on May 1, 2017. At present, National Medical Products Administration (NMPA) is firmly enforcing the “Administrative Measures on Medical Device Recall”. How do the overseas medical device manufacturers handle an overseas imported medical device recall smoothly in China? When is recall reporting voluntary vs. mandatory? What are characteristics and strategy of the recall that the overseas medical device manufacturers must consider when making the recall determination? How do the overseas medical device manufacturers comply with the Chinese latest medical device recall regulations? How do the overseas medical device manufacturers operate business smoothly in China? The regulations on medical device recall between China and US-EU are different. The overseas and multinational medical device manufacturers and their senior executive officers engaging in regulatory affairs need a comprehensive and thorough knowledge of the Chinese latest regulations on medical device recall. Latest guidebook for Chinese Medical Device Recall Regulations (2019 Edition) is an essential resource for overseas and multinational medical device manufacturers to handle a medical device recall smoothly in China, which provides not only a comprehensive knowledge of the Chinese latest medical device recall regulations, but also a detailed practical guidance for the overseas and multinational medical device manufacturers to handle an overseas imported medical device recall smoothly in China.
—An overview of organizational structure of Chinese regulatory authorities for medical device recall, which delineates a clear pathway for the overseas and multinational medical device manufacturers to submit the medical device recall reporting.
—Chinese special regulations for overseas medical device manufacturers, which tell the overseas medical device manufacturers must designate an agencies with legal person status within the territory of China or their representative office stationed in China to act as their agents to handle the adverse event of overseas imported medical device and recall the overseas imported medical device on the post-market in China. China’s regulatory approach is different from that of the US-EU
—The detailed general regulations for medical device recall, which cover the definitions relating to medical device recall, the practical guidance for who, where and how to submit medical device recall report, the investigation and evaluation of medical device defects, the classification for medical device recall, as well as information release for recalled medical device.
—The detailed regulations for voluntary recall of medical device, from the time limits of recall notifying, the indispensable content of the recall notification, the investigation and evaluation report, the recall plan, the periodical recall implementation report, disposal of recalled medical device to the recall summary report for terminating recall to guide you smoothly complete the recall, as well as a panoramic view of entire process of voluntary recall of medical device to let you understand at a glance.
—The mandatory recall of medical device, which covering how would trigger a mandatory recall of medical device, what the contents of recall order issued by the drug regulatory authorities will be contained, how the medical device manufacturer copes with a mandatory recall of medical device, and how to handle a mandatory recall of medical device smoothly in China, as well as a panoramic view of entire process of mandatory recall of medical device exhibited also to let you understand at a glance.
—The detailed legal liabilities for the medical device manufacturers, the marketing or distributing enterprises and the user facilities of medical devices, and the drug regulatory authorities and their staff for a medical device recall.
—How do remedy for patient.
—Two typical cases studies of overseas imported medical device recall to expose practical operation.
—A full set of the English and Chinese bilingual forms that are stipulated by the National Medical Products Administration (NMPA) to facilitate for you to operate them.

3 Reports

USD 8,250
  • PDF
  • EXCEL DATA (NO)
  • PPT (NO)
  • HARD COPY (NO)
  • 15% FREE CUSTOMISATION
  • 5 USERS
  • 3 ANALYST CALL
  • Add to cart

6 Reports

USD 15,000
  • PDF
  • EXCEL DATA
  • PPT (NO)
  • HARD COPY (NO)
  • 20% FREE CUSTOMISATION
  • 10 USERS
  • 12 ANALYST CALL
  • Add to cart

9 Reports

USD 20,250
  • PDF
  • EXCEL DATA
  • PPT
  • HARD COPY (NO)
  • 25% FREE CUSTOMISATION
  • 20 USERS
  • 22 ANALYST CALL
  • Add to cart

12 Reports

USD 24,000
  • PDF
  • EXCEL DATA
  • PPT
  • HARD COPY (NO)
  • 30% FREE CUSTOMISATION
  • UNLIMITED
  • 36 ANALYST CALL
  • Add to cart

Content
Chapter 1 Introduction
Chapter 2 An Overview of Chinese Regulatory Authorities for Medical Device Recall
Figure 2.1. Organizational Structure of Chinese Regulatory Authorities for Medical Device Recall
Chapter 3 Chinese Special Regulations for Overseas Medical Device Manufacturers
Chapter 4 General Regulations for Medical Device Recall
4.1. Definitions
4.2. Who, Where and How to Submit Medical Device Recall Report?
4.3. Investigation and Evaluation of Medical Device Defects
4.4. Classification for Medical Device Recall
4.5. Information Release for Recalled Medical Device
Chapter 5 Voluntary Recall of Medical Device
5.1. Voluntary Recall of Medical Device
5.2. Entire Process of Voluntary Recall of Medical Device
Figure 5.2. An Entire Process of Voluntary Recall of Medical Device
Chapter 6 Mandatory Recall of Medical Device
6.1. Mandatory Recall of Medical Device
6.2. Entire Process of Mandatory Recall of Medical Device
Figure 6.2. An Entire Process of Mandatory Recall of Medical Device
Chapter 7 Legal Liabilities
Chapter 8 Remedy for Patients
Chapter 9 Case Study
Case 1: GE Ultrasound Korea Ltd. Voluntarily Recalls Color Ultrasound Diagnostic Apparatus
Case 2: Medtronic Navigation Inc. Changes Recall Corrective Actions and Quantity for Surgical Navigation Systems and Brain Surgery Navigation System
Chapter 10 Appendices
10.1. Annex 1. Medical Device Recall Event Report Form
10.2. Annex 2.Recall Program Implementation Report

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.