We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Store » Device Products » China’s Medical Device Regulations - Webinar CD/Transcript

Other Options

Audio CD/Transcript - Sept. 13, 2017

$287.00

Audio CD/Transcript - Sept. 13, 2017

$258.00

Audio CD/Transcript - Sept. 13, 2017

$244.00

Audio CD/Transcript - Sept. 13, 2017

$230.00

Audio CD/Transcript - Sept. 13, 2017

$215.00

China’s Medical Device Regulations - Webinar CD/Transcript

$287.00
Device Products

Product Details

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.

  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing