Understanding CFDA’s New Regulations on Device Manufacturing
Thursday September 3, 2015 – 12:00PM EDT to 1:30PM EDT
This course is forecasted to be a 60 minute presentation with twenty to thirty minutes of Q&A.
John Balzano from Covington and Burling will present on developments in the regulation of medical device manufacturing in China over the last two years. In 2014, China overhauled its entire medical device regulatory system. That reform is related to a number of new measures to increase supervision of medical device manufacturers in China and raise the quality of domestically produced devices. This presentation will include an overview of the reformed manufacturing license system, new good manufacturing practices, contract manufacturing issues, and inspections and enforcement issues, as well as a perspective on potential future reforms.
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Quality Assurance
John C. Balzano
Covington & Burling LLP
John Balzano is Of Counsel in Covington and Burling’s New York office 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 and other regulatory issues, often as part of partnering or M&A deals.
In the medical device space, Mr. Balzano’s practice spans the lifecycle of the device from pre-clinical work through to post-marketing considerations and issues, including advertising and promotion and enforcement issues. Mr. Balzano also advises companies and industry associations on their advocacy strategy and understanding macro policy issues in China.