• 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
  • About us
    • Partners
    • Company Profile
    • Testimonials
  • Locations
  • 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
Contact
  • Home
  • News
  • News
  • NMPA Registration in China
  • Medical Device
  • Clinical Trial Guidelines Updated & Various Draft Product Guidelines Issued

Clinical Trial Guidelines Updated & Various Draft Product Guidelines Issued

Monday, 28 September 2020 / Published in Medical Device, News, NMPA Registration in China

Clinical Trial Guidelines Updated & Various Draft Product Guidelines Issued

On September 2, 2020, the Beijing MPA announced the clinical trial guidelines for medical devices in the Beijing municipalities. Required action items before, during, and after the clinical trial  were addressed.

Also, the CMDE (Center of Medical Device Evaluation, NMPA) announced the draft guidelines for the technical review of 3 test reagents and 1 medical device software, the clinicl trial of 1 test reagent, and the clinical evaluation for 2 medical devices.

Technical Review Guidelines (Draft)

  • Test reagents for cryptococcus antigen
  • Test reagents for rotavirus antigen
  • Test reagents for mutation in deafness-associated genes
  • Medical device software for cyber security
  • Drug-device combined products (under development)

Clinical Trial Guidelines (Draft)

  • Test reagents for anti-tumor medication already on the market

Clinical Evaluation Guidelines (Draft)

  • Medical magnetic resonance imaging (MRI) system
  • Ultrasonic cutting and hemostasis system for soft tissue

The CMDE began soliciting public comments once the draft guidelines were announced.

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

Tagged under: Clinical Trials, Draft Guidelines, Technical Review Guidelines

What you can read next

China clinical trials gcp
China Clinical Trials GCP – Important Changes for the Administration of Medical Device & IVD Clinical Trials
Draft of TSG 22 for mobile pressure vessels published for comments
NMPA medical device standards modifications
NMPA medical device standards modifications announced in September 2022

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

  • China cosmetics efficacy claims FAQ

    China cosmetics efficacy claims FAQ available to answer key questions

    China cosmetics efficacy claims FAQ is availabl...
  • China cosmetics GMP inspections

    China cosmetics GMP inspections points have been finalised

    China cosmetics GMP inspections points and judg...
  • China medical device quality safety responsibility

    China medical device quality and safety responsibility regulations come into force on March 1, 2023

    China medical device quality and safety respons...
  • China drug standards draft measures

    China drug standards draft measures have been published by the NMPA

    China drug standards draft measures have recent...
  • China special equipment safety supervision

    China special equipment safety supervision – draft provisions released

    China special equipment safety supervision regu...

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
Cookies on Cisema
Learn more about Cisema's Privacy Policy.