Medical Device Inspections in China - Webinar CD/Transcript

Quantity Discounts
1 - 2
3 - 4
5 - 6
7 - 9
10 - 9999

Medical Device Inspections in China

If you’re doing business in China or want to — you need to know the latest device inspection requirements for manufacturing devices in China or importing them into the country.

John Balzano, a leading authority on China medical device regulation, will provide an analytical introduction to China’s medical device regulations including GMPS, self-inspections, foreign inspections and enforcement trends and requirements for importing devices.

In 90 minutes, you’ll gain a practical understanding of the following compliance issues:

  • Implementation of the new GMPs, including the procedural rules for inspections, preparation, communicating with inspectors, resolving issues, and potential penalties.
  • Transfer of manufacturing sites and amendment of manufacturing and device licenses.
  • Policies and rules on contract manufacturing for medical devices.
  • Handling self-inspections and evaluations of past compliance, including recent examples.
  • Issues in importation, testing and new trends in e-commerce.

Order today to gain a comprehensive understanding of the regulations that will affect your operations in China.

  • Consultants/service providers
  • Engineering and design controls teams
  • Compliance officers
  • Executive management
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • QA/QC personnel
  • R&D staff
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Strategic planning and business development staff
  • Attorneys/legal department

John Balzano, Special Counsel, Covington and Burling, LLP
John Balanzo practices in the firm’s New York office in the 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.