• 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 class I medical device filing clarification

China class I medical device filing clarification

china class I medical device filing
Thursday, 25 August 2022 / Published in Medical Device, News, NMPA Registration in China

China class I medical device filing clarification

China class I medical device filing has been made clearer thanks to an announcement issued by the National Medical Products Administration (NMPA) on August 12, 2022.

The Announcement on Matters Related to the Filing Of Class I Medical Devices (including in vitro diagnostic reagents) is No. 62 of 2022 and repeals the 2014 version (No. 26 of 2014).

The “Announcement” clarified the following:

  • For the filing of domestic Class I medical devices, the filing entity shall submit the filing documentation to the department responsible for supervision and administration at the municipal district level (provincial Medical Products Administration or MPA).
  • For the filing of imported Class I medical devices, the filing entity shall submit the filing documentation to the NMPA.
  • When determining the product management category, the product description, expected use and product name examples shall be determined according to the product description, expected use and product name examples in:
    • the “Class I Medical Device Product Catalogue”
    • and “In Vitro Diagnostic Reagent Classification Sub-Catalogue”
  • To undertake correct filing of medical devices, the filing entity shall submit filing documentation that meets the requirements, complete the filing form, and obtain a filing number.
  • The filing entity shall ensure that the submitted documentation is legal, true, accurate, complete and traceable. Once the filing entity submits the required filing documentation, the filing is completed.
  • Data requirements for Class I medical device filing:
    • Class I medical device filing form
    • Associated files
    • Product technical requirements
    • Product inspection report
    • Product specification and minimum sales unit label design sample
    • Manufacturing information
    • Conformity Statement
  • The filing department (provincial MPA or NMPA) shall provide the filing entity with a filing number as well as proceed to publishing the relevant information found in the “Filing Information Form for Class I Medical Devices” or the “Filing Information Form for Class I In Vitro Diagnostic Reagents” on the filing information platform.
  • The NMPA shall establish a filing information platform to collect the filing information of Class I medical devices.
  • Provincial MPAs are responsible for collecting and submitting filing information of the Class I medical devices within their respective jurisdictions.

The main takeaway of this announcement is that the requirements for information are more concise and clearer. What’s more is that the requirements for a safety risk analysis report and clinical evaluation data in the original Announcement (No. 26 of 2014) have been deleted.

Further information

Click here to read the full announcement on China Class I medical device filing clarifications.

If you would like to know more about our services for medical device and IVD registrations in China, please contact us.

GET IN TOUCH

🌐 Send us your enquiry
📚 Request our whitepapers
📣 Sign up for our newsletter

What you can read next

Real-world data Application in China
NMPA and Allergan co-hosted the Webinar: Application of RWD and Fast-track Approval in Hainan Boao Lecheng International Medical Tourism Pilot Zone
Technical Guidelines Essential Principles
Technical Guidelines for Essential Principles of Safety and Performance of Medical Devices
Cisema Webinar on Medical and Cosmetic Product Certification

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.