• 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
  • First GLP Accredited Laboratory in China for Biocompatibility Testing

First GLP Accredited Laboratory in China for Biocompatibility Testing

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

First GLP Accredited Laboratory in China for Biocompatibility Testing

The Shandong Quality Inspection Center received the CNAS’s (China National Accreditation Service for Conformity Assessment’s) accreditation on October 24, being the first laboratory accredited for GLP (Good Laboratory Practice) in China to conduct biocompatibility testing on medical devices.

Biocompatibility testing is part of the overall assessment of the medical device and reflects the effects on a biological system to ensure the patient’s safety.

For the registration of medical devices in China, biocompatibility test reports conducted and issued by a GLP-compliant laboratory outside of China are the only non-local tests accepted by NMPA. In such cases, the GLP certificate is also required as part of the dossier submission. As Chinese laboratories also now obtain GLP certification it will make more sense for companies to conduct all testing including biocompatibility within China.

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

Tagged under: Biocompatibility, GLP, Good Laboratory Practice

What you can read next

china cross border data transfer security assessments
China cross border data transfer security assessments – new measures introduced
Guidelines for the Information Submission of Cosmetics Registration and Filing (Trial Version)
China SAMR 3 Stipulation Scheme Unveiled

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.