• 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
  • NMPA Further Clarifies Sampling Inspection Procedures for Medical Devices (Draft Amendment)

NMPA Further Clarifies Sampling Inspection Procedures for Medical Devices (Draft Amendment)

Sampling Inspection
Tuesday, 24 November 2020 / Published in Medical Device, News, NMPA Registration in China

NMPA Further Clarifies Sampling Inspection Procedures for Medical Devices (Draft Amendment)

On October 13, the NMPA (National Medical Products Administration) issued the draft document to improve the work efficiency of sampling inspection procedures and minimize processing times.

What’s new in the proposed regulation?

  • The inspection facilities’ application process and requirements
  • Workflow to ensure the newly designed checklist form has been completed before the inspection
  • The procedure to confirm the samples before the inspection will be removed

The NMPA has made announcements on March 10, 2020 (No.9-2020) and May 13, 2020 (No.46-2020), which served as a key basis to the development of the draft proposal. Read our previous articles about both announcements (No.9-2020 & No.46-2020).

NMPA Legal Agents will play a more important role when the document is finalized, due to their increased involvement in the sampling process and post-market surveillance requirements generally.

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

Tagged under: Sampling Inspection

What you can read next

China urgently needed drugs temporary import workflow
China “urgently needed drugs” temporary import workflow has been issued
Standardizing the Classification of Medical Devices
Draft Guideline Concerning OEM Quality Agreement for 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

  • 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.