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China’s Guidebook for Application and Approval of Imported Medical Device Registration

April 2012

With a huge population, growing economy, and healthcare aimed at covering 1.2 billion people, China could soon become the second-largest medical device market. But although China is a WTO member, its administrative measures are far from transparent. Many are downright variable, requiring great finesse with the cultural and political environments.

Any cost-benefit analysis for entering the Chinese device market must include the risk presented by these difficult and changing rules.

That’s why a new guide to the process can make such a difference to your success.

In this clear yet comprehensive new resource developed by Access China Management Consulting Ltd., FDAnews provides an English-language guide that makes it easier to navigate the Chinese medical device registration system.

China’s Guidebook for Application and Approval of Imported Medical Devices pulls together the latest relevant Chinese administrative and departmental regulations, as well as provisions for medical device registration. Step by step, it guides overseas medical device manufacturers and producers on what the regulations require and how to navigate China’s cultural and political realities to make a successful application and win approval.

Buy now to get the clear and current information you need to enter China’s medical devices market, including:

  • An overview of SFDA: The main responsibilities and organizational structure of China’s State Food and Drug Administration, which oversees imported medical device applications and approval

  • The latest laws and regulations: English translations of all the pertinent  Chinese requirements, including the Regulations for the Supervision and Administration of Medical Devices, the Measures for the Administration of Labels and Packing Marks of Medical Devices, the Provisions for Clinical Trials of Medical Devices, and the Provisions for Medical Device Classification

  • An overview of the entire process: Guidance on what to expect and how to approach each step from application to approval, including both the initial application as well as re-registration

  • Guidance on classification: Explanation of the Chinese medical devices classification system, including its guidelines, principles and criteria for classification.

  • Guidance for clinical trials: How to comply with specific registration requirements for clinical trials involving imported medical devices

Don’t let China’s complexity and cultural differences wall you off from a huge market for your medical devices.  Learn exactly what it takes to get your devices registered successfully.

China’s Guidebook for Application and Approval of Imported Medical Devices is offered by FDAnews in PDF format.

Your purchase is nonrefundable. All sales are final.

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