Understanding China's Medical Device Regulations - Webinar CD/Transcript

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Understanding China’s Medical Device Regulations

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.

John Balzano, a leading authority on U.S. and China medical device regulation, will break it all down for you in one 90-minute webinar CD and transcript. You’ll come away with a practical understanding of:

  • Significant changes in the basic requirements for registering a medical device in China;
  • Major changes in CFDA’s basic GxPs, including in the areas of manufacturing, distribution, and use of devices in medical institutions.  It will also discuss the role of other agencies, such as the National Health and Family Planning Commission, in policing unregistered devices;
  • How China is implementing its blueprint for drug and device reform released late last year; and
  • Impact of the proposal for medical device adverse event reporting and how the changes to the Advertisement Law in 2015 can affect the way devices are advertised and labeled.
  • Device Companies
  • CROs

John Balzano is special counsel in the New York office of Covington and Burling, LLP and practices in the firm’s food and drug group.  Mr. Balzano represents companies and industry associations on U.S. and China regulatory and policy matters in the drug, biologic, medical device (including in vitro diagnostics), cosmetic and food spaces.  He assists companies with compliance with the regulations of the China Food and Drug Administration (CFDA) and the National Health and Family Planning Commission (NHFPC) and advises on how to develop strategies for bringing their products to market in China.