• EnglishEnglish
    • Deutsch Deutsch
    • Italiano Italiano
    • Français Français
    • 日本語 日本語
    • 한국어 한국어

CISEMA - China Zertifizierung, Einkauf und Qualitätssicherung

  • Services
    • NMPA Registration – Medical Devices and IVDs
    • NMPA Registration – Cosmetics
    • NMPA Registration – Health Food
    • DMF (Drug Master Filing) – Pharmaceutical Products
    • CCC (China Compulsory Certification) – Industrial and consumer goods
    • CML (China Manufacture Licence) – Pressure vessels
    • Others
      • Sourcing and Quality Control
      • Logistics and Customs Support
      • Sales Support
  • About us
    • Company Profile
    • Partners
    • Testimonials
  • Locations
  • Events
    • Trade Fairs & Conferences
    • Seminars
    • Webinars
  • News & Information
    • Regulatory News
      • Medical Devices and IVDs
      • Cosmetics
      • DMF
      • CCC
      • Pressure Vessels
    • Publications
    • Brochure
    • Online Shop
Contact
  • Home
  • News
  • News
  • NMPA Registration in China
  • Medical Device
  • Global Regulators Forum Accepts China’s Proposal on “Post-Market Clinical Follow-Up Studies” and Seeks Industry Comment

Global Regulators Forum Accepts China’s Proposal on “Post-Market Clinical Follow-Up Studies” and Seeks Industry Comment

Tuesday, 24 November 2020 / Published in Medical Device, News, NMPA Registration in China

Global Regulators Forum Accepts China’s Proposal on “Post-Market Clinical Follow-Up Studies” and Seeks Industry Comment

On October 11, the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) published the Post-Market Clinical Follow-Up Studies for Medical Devices (draft) on the official website of the IMDRF (International Medical Device Regulator Forum).

The proposal document (in English and Chinese) provides guidance in relation to:
– The circumstances where a post-market clinical follow-up (PMCF) study is indicated
– The general principles of PMCF studies involving medical devices
– The design and implementation of PMCF studies
– The use of information from PMCF studies

Although PMCF studies are not intended to replace the premarket data necessary for market authorization, it is one of the several options available in a post-market surveillance program and can contribute to the risk management process.

The acceptance by IMDRF of China’s proposal on PMCF studies is significant, because it shows the growing global leadership and maturity of the Chinese regulator and medical device industry. It is also likely to soon result in updated regulation of PMCF studies in China. Such studies are an important supplement to a manufacturer’s post-market compliance.

IMDRF is a voluntary group formed by regulators from the global medical device industry. The public consultation is currently open for comments until December 11, 2020. Let us know if you would like to send us your comments on the draft, and together we can submit a strong proposal to the CMDE and IMDRF.

By Jacky Li. Contact Cisema if you would like to learn more.

Tagged under: CMDE, IMDRF, Medical Devices, PMCF, post-market clinical follow up, post-market surveillance, risk management

What you can read next

Updates on the Medical Device Classification Catalogue in China
Public Consultation on Overseas Inspection for Cosmetics
China – CCC Certification Obligation Lifted for Numerous Products

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Search

Categories

  • Fairs & Events
  • News
    • CCC
    • CEL
    • CML, SELO
    • Medical Devices Listing in Hong Kong
    • NMPA Registration in China
      • Cosmetics
      • Drug Master Filing
      • Health Food
      • Medical Device
    • RoHS
  • Publications
  • Seminars
  • Webinars

Recent Posts

  • Cisema Webinar: Greater Bay Area Initiative and China NMPA Registration for Medtech

    On April 15, 2021, Cisema will cohost a webinar...
  • Cisema to attend CMEF 2021

    Once again, Cisema will be participating in the...
  • Cisema Webinar Series: NMPA Registration of Medical Devices in China

    In the first webinar of the series, we were del...
  • New Regulatory Updates Concerning Health Food Filing

    On February 20, 2021, the SAMR (State Administr...
  • New Regulatory Controls to Support the CSAR Including Animal Testing Exemptions

    On March 4, 2021, the NMPA announced the Provis...

Archive

Cisema

With twelve locations and over ninety highly qualified employees, Cisema can offer you optimal support in China.

Services

  • Certification
  • Sourcing and Quality Control
  • Logistics and Customs Support
  • Sales Support

Dialogue

  • Contact us
  • Events
  • News & Information
  • Partners

Company

  • GTC
  • Privacy Statement
  • Legal Notice
  • About us
  • Locations
  • GET SOCIAL

© 2021 Cisema. All rights reserved.

TOP