• 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
  • Cosmetics
  • China NMPA Finalizes the “Measures for the Supervision and Administration of Production and Operation of Cosmetics”

China NMPA Finalizes the “Measures for the Supervision and Administration of Production and Operation of Cosmetics”

Monday, 23 August 2021 / Published in Cosmetics, News, NMPA Registration in China

China NMPA Finalizes the “Measures for the Supervision and Administration of Production and Operation of Cosmetics”

On August 6, 2021, the NMPA (National Medical Products Administration) announced the “Measures for the Supervision and Administration of Production and Operation of Cosmetics” to support the implementation of the CSAR (Cosmetics Supervision and Administration Regulation). The finalized regulation will be implemented on January 1, 2022.

General Provisions

According to the regulation, the registrants and filing persons should fulfill the obligation to:

  • Establish a quality management system for production
  • Monitor adverse events, manage risk control and product recall activities
  • Account for product quality, safety and efficacy claims

Highlights

The person responsible for quality and safety should carry out the following duties for production management:

  • Establish and organize the implementation of the quality management system;
  • Review the product formulas, production processes, ingredient suppliers, etc.;
  • Material release management and product release;
  • Monitoring and management of cosmetics adverse events;
  • Supervision and management of production activities of the contracted/entrusted production enterprises

Factory inspection must be qualified before selling into the China market and the retention of samples should be managed as below:

  • Registrants or the filing persons shall retain the cosmetic samples and the original packaging
  • The number of samples should meet the quality inspection requirements
  • Sample retention period shall not be less than 6 months after the date of product expiration

Self-inspection on the production and quality management system should be conducted following the requirements below:

  • Self-inspection report should cover the following items:
    • Issues detected
    • Product safety and quality assessment
    • Rectification measures
  • The retention period of self-inspection reports should be no less than 2 years.
  • For cosmetics that stopped manufacturing for over 1 year:
    • Domestic and overseas factories can start again for production only if self-inspection has been conducted and confirmed meeting the respective requirements
    • After the production relaunch, domestic factories must submit the self-inspection report (and include any changes) to the respective MPA within 10 working days

By James Xu. Contact Cisema if you would like to learn more.

Tagged under: cosmetics, cosmetics filing, cosmetics registration, Cosmetics Supervision and Administration, CSAR

What you can read next

china cosmetics quality and safety
China Cosmetics Quality and Safety Manager Qualification Requirements Eased by NMPA
China drug annual reports
China Drug Annual Reports – How to File in China?
China UDI requirements
China UDI requirements for third batch of medical devices – Draft issued

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.