Understanding China’s New Medical Device Regulations, 2016 Edition

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Understanding China's New
Medical Device Regulations
2016 Edition

China has dramatically revamped its medical device regulations in every major area including:

  • Research and development
  • Approval
  • Manufacturing
  • Distribution
  • Post-market surveillance

And its equivalent of the FDA, the CFDA, isn't close to being finished with ticketing advertising and promotion, adverse event reporting, and device classification for new regulation this year.

This new edition of Understanding China's New Medical Device Regulations includes a new updated chapter written by experts John Balzano and Christopher Chen of Covington and Burling, LLP that explains:

  • The Good Clinical Practices requirements that took effect on June 1, 2016
  • The recently released new clinical trial exemption catalogs
  • How the CFDA restructured its medical device adverse event regulations last December

You'll learn real specifics as you work your way through the incredible detail of this report, covering such areas as:

  • Changes in the basic requirements for registering a medical device in China, including moratoriums on devicemakers that fail to satisfy registration requirements and, in serious cases, even revoke their licenses.
  • CFDA's greater enforcement power to order recalls, terminate sales, freeze imports and, most importantly, issue larger penalties to and even shut down devicemakers.
  • New, more lenient rules governing the completion of manufacturing facilities before registering devices.
  • New guidance on when contract manufacturers can produce devices for another company.
  • And much more

Order your copy today and stay on top of China's medical device regulations.


PDF Edition

Available Format

PDF Edition — $397

Who Will Benefit

  • Regulatory affairs
  • Compliance
  • Legal

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