• 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
  • China NMPA Updates Fast Track Approval Measures for Medical Devices

China NMPA Updates Fast Track Approval Measures for Medical Devices

Tuesday, 25 January 2022 / Published in Medical Device, News, NMPA Registration in China

China NMPA Updates Fast Track Approval Measures for Medical Devices

On December 29, 2021, the NMPA (National Medical Products Administration) issued (No.157-2021) the new finalized emergency approval procedures for medical devices with immediate effect to replace the previous version issued in 2009.

Scope

The emergency approval procedures can be applied to domestic class III, imported class II and class III medical devices for either one of the following purposes:

  • In response to the needs of public health emergencies whilst no similar products have been marketed in China; or
  • In response to the insufficient supply of similar products that have already been marketed in China to handle public health emergency situations.

What’s new

  • After the emergency approval and conditional approval are granted, if the conditions listed on the license of registration is completed within the 1 year expiration whilst the requirements for renewal have also been met, the license of registration can be renewed for 5 years.
  • Once the application for emergency approval is confirmed accepted by the NMPA, the applicants are required to complete the dossier submission and related requirements within 90 days, otherwise, the application can no longer be applicable for emergency approval.

Innovative and Priority Approval

On December 2, 2021, the CMDE (Center for Medical Device Evaluation) of the NMPA published the revised version of the administrative provision on communication and information exchange for the technical review of innovative and priority approvals.

Once the medical device is confirmed to be an innovative product, the evaluation department and clinical department under the CMDE will arrange the first conference meeting with the applicant, and communicate at least once every year to follow up on the status of the product development prior to the application for registration.

For general technical issues, the applicant can get in touch with the CMDE by phone, email, etc. Otherwise, an application for conference meeting should be submitted by the applicant and approved by the corresponding CMDE department to discuss on major technical or safety problems, clinical trial protocol, summary and evaluation of phased clinical trial results, etc.

For fast track approval related to emergency, innovative, and priority approvals, contact Cisema if you would like to learn more.

By Alice Liu and Jacky Li.

What you can read next

Clinical Trials & Import of Veterinary Drugs
CMDE Analyzes the Typical Issues for Combination Product Registrations
medtech cosmetics and pharmaceutical webinars
Medtech, Cosmetics and Pharmaceuticals Webinars, Collaborations and Events Towards the End of the Year 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 medical device sampling inspection results

    China medical device sampling inspection results no.4 of 2022

    China medical device sampling inspection result...
  • NMPA cosmetic sampling inspection

    The NMPA Cosmetic Sampling Inspection measures come into force on March 1, 2023

    NMPA Cosmetic Sampling Inspection Measures come...
  • China cosmetics quality safety responsibilities

    China cosmetics quality and safety responsibilities regulations released

    China cosmetics quality and safety responsibili...
  • 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...

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.