• 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 – Cosmetics
    • NMPA Registration – Health Food
    • DMF (Drug Master Filing) – Pharmaceutical Products
    • CCC (China Compulsory Certification) – Industrial and consumer goods
    • CML (China Manufacture Licence) – Pressure vessels
    • Others
      • Sourcing and Quality Control
      • Logistics and Customs Support
      • Sales Support
  • About us
    • Company Profile
    • Partners
    • Testimonials
  • Locations
  • Events
    • Trade Fairs & Conferences
    • Seminars
    • Webinars
  • News & Information
    • Regulatory News
      • Medical Devices and IVDs
      • Cosmetics
      • DMF
      • CCC
      • Pressure Vessels
    • Publications
    • Brochure
    • Online Shop
Contact
  • Home
  • News
  • News
  • NMPA Registration in China
  • Medical Device
  • Latest Technical Review Guidelines Issued / Updated

Latest Technical Review Guidelines Issued / Updated

Thursday, 22 October 2020 / Published in Medical Device, News, NMPA Registration in China

Latest Technical Review Guidelines Issued / Updated

 In September 2020, the NMPA issued the following guidelines:

  • Technical review guideline for balloon dilation catheters
  • Technical review guideline for infusion products with sharp injury prevention features
  • Fatigue performance evaluation guideline for bio-type femoral stems
  • Guideline on the validation of virus inactivation for allogeneic transplants (amended 2020 version)
  • Guideline on reviewing the registration of 3D-printed lower jaw prosthesis
  • Guideline on quality control for customized bone implants and tools
  • Guideline on reviewing the registration of single use pen needles (draft)

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

Tagged under: allogeneic transplants, balloon dilation catheters, bone implants, infusion products, lower jaw prosthesis, pen needles, stems, Technical Review Guidelines

What you can read next

More Diversity Thanks to Five Additional CCC-Certification Bodies
NMPA Major Updates Concerning IVDs
Preview of Supplementary Files Available to First-Time Medical Device Registrants

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Search

Categories

  • Fairs & Events
  • News
    • CCC
    • CEL
    • CML, SELO
    • Medical Devices Listing in Hong Kong
    • NMPA Registration in China
      • Cosmetics
      • Drug Master Filing
      • Health Food
      • Medical Device
    • RoHS
  • Publications
  • Seminars
  • Webinars

Recent Posts

  • Updates on the Medical Device Classification Catalogue in China

    On December 31, 2020, the NMPA announced (No.14...
  • Cisema Partners with Advamed

    Cisema is delighted to announce it is now an as...
  • Guidelines for Sampling Testing on Organic Foods

    On December 4, 2020, the CNCA (Certification an...
  • Draft of Prohibited List and Existing List of Cosmetic Ingredients Announced

    On January 22, 2021, the NIFDC (China National ...
  • Guideline and Standard Update for Medical Devices & IVDs in January and February 2021

    China Regulatory Guidelines Issued / Updated Th...

Archive

Cisema

With nine 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
  • Events
  • News & Information
  • Partners

Company

  • GTC
  • Privacy Statement
  • Legal Notice
  • About us
  • Locations
  • GET SOCIAL

© 2019 Cisema. All rights reserved.

TOP