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.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Store » Research and Development » How to Get IVD Approval Through CFDA - Webinar Recording/Transcript

Other Options

Audio Recording/Transcript - Jan. 17, 2018

$287.00

Audio Recording/Transcript - Jan. 17, 2018

$258.00

Audio Recording/Transcript - Jan. 17, 2018

$244.00

Audio Recording/Transcript - Jan. 17, 2018

$230.00

Audio Recording/Transcript - Jan. 17, 2018

$215.00

How to Get IVD Approval Through CFDA - Webinar Recording/Transcript

$287.00
Research and Development

Product Details

How to Get IVD Approval Through CFDA: Key Premarket Submission Tips

Marketing into Asia just got more complicated for device and IVD makers. The China FDA (CFDA) has changed the rules significantly on IVDs, and further changes are expected. Plus, lest you forget, most IVDs require clinical trials in China. (They’re clinically exempt in the U.S. and the E.U.)

FDAnews has invited China FDA expert Grace Fu Palma to bring you up to speed. Her 90-minute presentation is a must for the medical device and IVD community wanting a piece of China’s booming IVD market (20% growth year after year!). Prepare to dig deep into these key topics:

  • CFDA IVD registration requirements and how they differ from FDA classifications
  • How to prepare samples to pass local IVD approval tests
  • Differences in motivation and criteria between U.S. and China IVD regulatory schemes
  • Changes in the clinical trial exemption catalog
  • Changes in CFDA #650 medical device supervision and monitoring in regard to registration of legal agents
  • And much more!

That’s a lot of ground to cover in just 90 minutes. China’s regulators have been busy:

  • Clinical trial exempt list catalog was released on Oct. 30, 2017
  • Clinical trial exempt IVD CER requirements if not clinical trial were promulgated Nov. 8, 2017
  • Medical device supervision and monitoring (#650) registration legal agent status is expected to be changed soon

Success in the booming China IVD market requires a thorough understanding of how that nation regulates IVDs and how those regulations are changing. This webinar can help protect your competitive edge.

  • 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 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing