FDAnews Announces — Understanding China’s Medical Device Regulations Webinar, April 12, 2016

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There has been an explosion of new and revamped regulations for medical devices in China. John Balzano, a leading authority on U.S. and China medical device regulation, will break it all down in one 90-minute webinar.

Understanding China’s Medical Device Regulations
April 12, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/understandingchinasmdreg    

There has been an explosion of new and revamped regulations for medical devices in China.

John Balzano, a leading authority on U.S. and China medical device regulation, will break it all down in one 90-minute webinar. Attendees will 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.

For companies that do business in or with China, this is a must-attend webinar.

Meet the Presenter:
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.

Who Will Benefit:

  • Device Companies
  • CROs

Webinar Details:
Understanding China’s Medical Device Regulations
April 12, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/understandingchinasmdreg    

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/understandingchinasmdreg
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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