FDAnews Announces: Understanding China’s New Medical Device Regulations Webinar, March 26, 2015

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There has been an explosion of new and revamped regulations for medical devices in China. John Balzano, a foremost authority on U.S. and China medical device regulations will cover how the new China rules for devices will be implemented, and address major concerns in detail during the Understanding China's New Medical Device Regulations webinar on March 26.

Understanding China’s New Medical Device Regulations
**FDAnews Webinar**
March 26, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/UnderstandingChinaMDRegs

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

These new regulations touch on all aspects of medical devices — research and development, approval, manufacturing, distribution, and post-market surveillance. And they affect all devices — those currently in development as well as those that are already on the market.

John Balzano, a foremost authority on U.S. and China medical device regulations will cover how the new China rules for devices will be implemented, and address major concerns in detail, including:

  • Changes in the basic requirements for registering a medical device in China (Some devices that previously needed registration no longer require it, while others do.)
  • Increased enforcement powers for the CFDA to order recalls, terminate sales, freeze imports, issue greater penalties to devicemakers and shut down devicemakers
  • New authority to impose a moratorium on a devicemaker who fails to satisfy registration requirements or even revoke licenses in serious cases
  • New requirements for elements that must be listed on a device’s label
  • Changes to medical device classification rules — including new requirements for registering Class I devices and new categories of devices
  • New, more lenient rules governing when a manufacturer must have its manufacturing facility completed before registering a device
  • And much more…

Attendees will come away from this 90-minute session understanding how the new regulations will affect operations in China … the problems companies are already encountering with the new regulations … and how they’re solving those problems.

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

Conference Details:
Understanding China’s New Medical Device Regulations
**FDAnews Webinar**
March 26, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/UnderstandingChinaMDRegs
Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/UnderstandingChinaMDRegs
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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