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Latest guidebook for Chinese Medical Device Recall Regulations (2014 Edition) - Product Image

Latest guidebook for Chinese Medical Device Recall Regulations (2014 Edition)

  • Published: February 2014
  • Region: China
  • 34 Pages
  • Access China Management Consulting Ltd

Summary:

China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, medical devices represented dynamical growth since 2000s. By 2013, total value of medical devices on Chinese healthcare market has reached 179 billion RMB.

Medical devices have been widely used in the process of disease prevention, diagnosis, therapy, care and rehabilitation. It is estimated that Chinese medical device market will be likely to be more than 340 billion RMB by 2015, and will surpass Japan to become the second largest medical device market following the United States. The Chinese medical device market will attract more and more overseas medical device manufacturers and producers to penetrate such market.

If you search on website of the Chinese regulatory authority of medical devices, China Food and Drug Administration, you may find there are many announcements of medical devices recall for those that made by overseas and multinational READ MORE >

Chapter 1 Introduction.

Chapter 2 An Overview of Chinese Regulatory Authorities for Medical Device Recall.

Chapter 3 General Regulations for Medical Device Recall.
3.1. Definitions.
3.2. Who, Where and How to Submit Medical Device Recall Report?.
3.3. Investigation and Evaluation of Medical Device Defects.
3.4. Classification for Medical Device Recall .

Chapter 4 Voluntary Recall of Medical Devices.
4.1. Regulations for Voluntary Recall of Medical Devices.
4.2. Entire Process of Voluntary Recall of Medical Devices.

Chapter 5 Mandatory Recall of Medical Devices.
5.1. Regulations for Mandatory Recall of Medical Devices.
5.2. Entire Process of Mandatory Recall of Medical Devices.

Chapter 6 Legal Liabilities.

Chapter 7 Remedy for Patient.

Chapter 8 Case Study U.S. Philips Medical Systems (Cleveland), Inc. Recall Single Photon Emission Computed Tomography System

Chapter 9 Appendix.
9.1. Medical Device Recall Event Report Form.
9.2. Recall Program Implementation Report.
9.1. Medical Device Recall Event Report Form.
9.2. Recall Program Implementation Report.

List Of Figures:

Figure 2.1. Organizational Structure of Chinese Regulatory Authorities for Medical Device Recall.
Figure 4.2. Entire Process of Voluntary Recall of Medical Devices.
Figure 5.2. Entire Process of Mandatory Recall of Medical Devices.

Note: Product cover images may vary from those shown

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