China’s Medical Device Regulations - Webinar CD/Transcript

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China’s Medical Device Regulations: Keys to Selling More in a Hot Market

China, the hottest medical device market on the planet, is welcoming U.S. devicemakers. A push is on to streamline importation of medical devices, including letting U.S. drugmakers set up production in China and collaborate with local manufacturers.

The price is a familiar one: Compliance with China’s regulations. They’re complicated, and — no surprise — changing fast.

Looks like time to call a lawyer. A China specialist, specifically — one who spends every working day with Chinese device regulation on behalf of clients like you. Or better yet...

Over 90 information-packed minutes, John Balzano Esq. of Covington & Burling’s New York office  will guide you through China’s regulatory maze, including changes to GMPs, self-inspections, foreign inspections, and enforcement actions and campaigns. In recent months, China’s FDA (CFDA) has taken the following actions:

  • Proposed a new medical device classification catalogue
  • Set forth priority and expedited pathways for devices to serve unmet clinical needs
  • Issued regulations on device clinical trials, procedures and positive lists for applying for exemptions from the in-country clinical trial requirement
  • Made moves affecting post-marketing surveillance, including new recall regulations and proposals for new adverse event regulations
  • And much more.

Don’t turn your back on a nation of 1.4 billion and an economy growing nearly 6.7% a year. Learn the China rules ... and get your share of the China market.

  • Executive management
  • Strategic planning and business development
  • Engineering/design controls
  • QA/QC/QR
  • Manufacturing directors and supervisors
  • R&D
  • Compliance officers
  • Regulatory affairs
  • Risk management specialists
  • Personnel new to the industry
  • Legal counsel
  • Consultants/service providers

John Balzano is special counsel in the New York office of Covington and Burling LLP, representing clients in the drug, biologics, device (including in vitro diagnostics), cosmetic and food spaces. He specializes in compliance with China Food and Drug Administration (CFDA) and the National Health and Family Planning Commission (NHFPC) regulation, and advises clients on developing strategies to bring products to market in China.