China Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation

May 22, 2015, 07:45 ET from Research and Markets

DUBLIN, May 20, 2015 /PRNewswire/ -- Research and Markets(http://www.researchandmarkets.com/research/28m7nx/guide_to_prepare) has announced the addition of the "Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China (2014 Edition) " report to their offering.

The Chinese medical device market is one of segment market of the most growth potentiality, which is attracting more and more overseas medical device manufacturers and producers to penetrate such market. It is estimated that Chinese medical device market will be likely to be more than 340 billion RMB (about 57 billion US dollars) by 2015, and will surpass Japan to become the second largest medical device market behind the United States.

However, China's regulatory framework for medical devices is undergoing radical changes. China's new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid population growth and thriving economy over the past 30 years. Chinese state council issued the latest Regulations for the Supervision and Administration of Medical Devices on February 12, 2014, and it has come into force as of June 1, 2014. China Food and Drug Administration issued the latest Measures for the Administration of Medical Device Registration, and it has come into force as of October 1, 2014. The overseas medical devices exporting into China market should be subject to administration of overall new regulations since October 1, 2014.

Guide to Prepare Application Dossiers for Oversea Medical device registration and recordation in China (2014 Edition) not only provided a comprehensive and thorough knowledge of the overall new requirements of application dossiers for medical device registration or recordation in China but also provided the guidance of practical operation for how to achieve a successful approval for your products entry into the Chinese medical device market.

Key Topics Covered:

Chapter 1 Executive Summary.

Chapter 2 What Chinese Regulations on Medical Device are Undergoing

Chapter 3 Latest Chinese Applicable Regulations for Medical Device Registration and Recordation.

Chapter 4 Knowledge Preparation of Preparing Application Dossiers for Imported Oversea Medical Device Registration or Recordation.

Chapter 5 How Many Application Dossiers for Imported Oversea Medical Device Recordation should be Prepared.

Chapter 6 Requirements for Application Dossiers of Imported Oversea Medical Device Recordation.

Chapter 7 How Many Application Dossiers for Imported Oversea Medical Device Registration should be Prepared.

Chapter 8 Requirements for Application Dossiers of Imported Oversea Medical Device Registration.

Chapter 9 List of Basic Requirements for Safety and Effectiveness of Medical Device Product.

Chapter 10 How to Compile the Product Technical Requirements.

Chapter 11 How to Apply for Registration Test.

Chapter 12 How to Compile the Instructions and Labels of Medical Devices.

Chapter 13 How to Conduct the Clinical Evaluation for Imported Overseas Medical Device Registration in China.

Chapter 14 How to Conduct the Clinical Trials of Imported Medical Device Registration in China.

Chapter 15 Submission of Application Dossiers and Approval Process.

Chapter 16 Appendices.

For more information visit http://www.researchandmarkets.com/research/28m7nx/guide_to_prepare

Media Contact: Laura Wood , +353-1-481-1716, press@researchandmarkets.net

SOURCE Research and Markets



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