Understanding China’s New Medical Device Regulations - Webinar CD/Transcript

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Understanding China’s New Medical Device Regulations

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

Many new Chinese regulations went into effect in late 2014, and already in 2015, more have been proposed, many of which will be finalized this year.

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.

Are you fully prepared for this onslaught of new regulations in China? Are you sure that you understand them sufficiently to avoid delays getting your products on the market … and maintain your existing licenses?

"I think so …" is NOT an adequate answer. But if it is your answer, help is available NOW that will make you feel 100% confident of yourself.

Order the FDAnews webinar CD and transcript Understanding China’s New Medical Device Regulations.  The leader, John Balzano, is a foremost authority on U.S. and China regulatory and policy matters in the medical device, drug, biologic, cosmetic, and food spaces.

Look at his incredible qualifications — and imagine how much you will learn from him. Mr. Balzono has been a professor of Chinese law at Boston University Law School and Yale Law School … senior fellow at the China Law Center of Yale Law School, where he conducted joint legislative research projects on food and drug and administrative law with various branches and agencies of the Chinese government … and now is special counsel to the food and drug group in the New York office of Covington and Burling, LLP.

Mr. Balzano covers how the new China rules for devices will be implemented, and addresses your 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
  • Revisions to how long a medical device’s certificate is valid
  • Changes and additions to the regulations that cover in vitro diagnostics
  • Emerging requirements for in-country clinical trials needed to enter the Chinese market (as well as exemptions to these requirements for certain devices)
  • New guidance on when contract manufacturers can be used to produce devices for a company
  • Simpler, new notification and licensing requirements for some distributors
  • Changes to the core post-marketing requirements for devicemakers … future changes that are pending … and opportunities for you to help influence those regulations

What you will learn: You'll come away from this 90-minute session understanding how the new regulations will affect your operations in China … the problems companies are already encountering with the new regulations … and how they’re solving those problems.

You'll profit by learning from the mistakes of your competitors — with the guidance of a top notch, acknowledged expert in medical device regulation in China.

What more could you possibly ask for?

  • 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.