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 » China FDA Exempts ‘Equivalent’ Devices from Clinical Trials

China FDA Exempts ‘Equivalent’ Devices from Clinical Trials

May 29, 2015

Devicemakers won’t have to stage new clinical trials of their devices to gain approval in China if they can demonstrate that they’re basically equivalent to devices already on the market, Chinese regulators say.

To get around the trial requirement, devicemakers must submit data from a trial of an older device to which the newer one is being compared. Two devices may be deemed equivalent if the differences in their operating principles, structures, materials, production processes, safety evaluation, applicable national or industry standards and intended use are so minor as to not affect the device’s safety or efficacy, a new guideline released by the China Food and Drug Administration says.

The guideline also exempts so-called catalog products from clinical trials. Evidence shows they are equivalent to items on the CFDA’s formal list of devices exempted from clinical studies.

For most devices requiring clinical trials, the manufacturers may submit data from overseas studies as long as the trial design meets Chinese standards for sample size, control group selection and end point. The data must also show that the device is equally effective across different ethnic groups. That does not apply to certain Class III devices, which require Chinese trial data, the CFDA says.

For lower-risk products, literature reviews conducted in major scientific databases and empirical data collected from clinical use of the device, including adverse event reports, may be acceptable, the agency adds.

View the guideline, in Chinese, at www.fdanews.com/06-01-15-china.pdf. — Elizabeth Orr

Regulatory Affairs Research and Development

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • WhiteHouse.gif

    President Biden Issues Executive Order on U.S. Supply Chain

  • roche.gif

    Priority Healthcare Settles Diabetes Test Lawsuit with Roche for $43 Million

  • Effective text

    Pfizer/BioNTech Vaccine Equally Effective for All Age Groups, Israeli Study Says

  • Siemens Healthineers logo

    Siemens Healthineers’ COVID-19 Antigen Lab Test Receives CE Mark

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • 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