• 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 & DMF – Pharmaceuticals
    • NMPA Registration – Cosmetics
    • NMPA Registration – Health Food
    • CML (China Manufacture Licence) – Pressure vessels
    • CCC (China Compulsory Certification) – Industrial and consumer goods
    • Others
      • Sourcing and Quality Control
      • Logistics and Customs Support
      • Sales Support
  • Events
    • Trade Fairs & Conferences
    • Seminars
    • Webinars
  • News & Knowledge
    • Regulatory News
      • Medical Devices and IVDs
      • Cosmetics
      • Pharmaceuticals & DMF
      • CCC
      • Pressure Vessels
    • Whitepapers
    • FAQ – NMPA Registration – Medical Devices and IVDs
    • Newsletter Sign Up
    • Others
      • Publications
      • Online Shop
  • About us
    • Partners
    • Company Profile
    • Testimonials
  • Locations
  • Newsletter Sign Up
Contact
  • Home
  • News
  • News
  • NMPA Registration in China
  • Medical Device
  • Technical Review Guidelines in Draft for Medical Devices Clinical Trial Data Submission

Technical Review Guidelines in Draft for Medical Devices Clinical Trial Data Submission

Tuesday, 28 September 2021 / Published in Medical Device, News, NMPA Registration in China

Technical Review Guidelines in Draft for Medical Devices Clinical Trial Data Submission

On September 16, 2021, the CMDE (Center for Medical Device Evaluation) of the NMPA released the draft of Technical Review Guidelines for the Submission Requirements of Clinical Trial Data for Medical Devices.

Highlights

The submission of clinical trial data should follow the four basic principles below:

  • “Traceability” means that the statistical results reproduced from the analytical database and clinical trial reports should be consistent with the data and code submitted by the applicants
  • “Legibility” means that the submitted clinical trial data should be consistent with the information contained in the Case Report Form. If there are any errors detected, the researcher should be informed with record. The researcher should then sign and confirm before the corrected data is uploaded.
  • “Easiness to read” means the reviewer‘s level of familiarity and mastery of the submitted data variables and the relationships between the variables in order to carry out a statistical and analytical review. According to the draft guidelines, the submission of clinical trial data should increase the level of easiness to read.
  • In general, there is a standard file format for clinical trial data of medical devices such as the original database, analytical database, descriptive documentation and codes that should all be stored in a master folder before submission.

The draft guidelines do not cover the clinical trial data for IVDs and real world data, but only the clinical trial data for medical devices.

By Dora Yang and Jacky Li. Contact Cisema if you would like to know more.

Tagged under: clinical trial, clinical trial data

What you can read next

China drug registration evaluation
China drug registration evaluation report 2021 released
Examination of Medical Device Applications
China Still Finalizing the Details for Self-Testing on Medical Devices

Search

Categories

  • Fairs & Events
  • News
    • CCC
    • CEL
    • CML, SELO
    • Medical Devices Listing in Hong Kong
    • NMPA Registration in China
      • Cosmetics
      • Health Food
      • Medical Device
      • Pharmaceuticals & DMF
    • RoHS
    • Voluntary Product Certification
  • Publications
  • Seminars
  • Uncategorized
  • Webinars

Recent Posts

  • Submission of safety information for cosmetics ingredients

    Submission of safety information for cosmetics raw materials – Draft guidelines issued

    Submission of safety information for cosmetics ...
  • avoid animal testing in Chinaweb-2023

    How to avoid animal testing in China for cosmetics | Cisema Webinar

    China’s beauty and cosmetic market has be...
  • guidelines for medical devices registration

    Guidelines for medical devices registration in China – New development plans in 2023

    Guidelines for medical devices registration in ...
  • China DMF of API

    China DMF of API, Excipient & Packaging Materials: Market & Regulatory | Cisema Webinar

    “China DMF of API, Excipient & Packag...
  • pre-phase III drug clinical trial meeting guidelines

    Pre-phase III drug clinical trial meeting guidelines released

    Pre-phase III drug clinical trial meeting guide...

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
  • Newsletter Signup
  • Events
  • News & Knowledge
  • Partners

Company

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

© 2021 Cisema. All rights reserved.

TOP