• 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
  • 15 New NMPA Technical Review Guidelines for Medical Device Registrations

15 New NMPA Technical Review Guidelines for Medical Device Registrations

Friday, 17 July 2020 / Published in Medical Device, News

15 New NMPA Technical Review Guidelines for Medical Device Registrations

On June 5, the NMPA issued the technical review guidelines (No. 36 – 2020) for the registration of the following medical devices:

  • Tendons and Ligament Fixation Device
  • 3D Printed Acetabular Cup
  • 3D Printed Artificial Vertebral Body
  • Facial Implants for Plastic Surgery
  • Total Knee Prosthesis System

On June 17, the NMPA issued the technical review guidelines (No. 39 – 2020) for the registration of the following medical devices:

  • Heat and Moisture Exchanger
  • Low Frequency Electrotherapy Instrument
  • Electrical Pneumatic Tourniquet Device
  • Spirometry Device
  • Medical CO2 Incubator
  • Shockwave Therapy Device
  • Hot Therapy Pack
  • Audiometer

On June 17, the NMPA issued the technical review guidelines (No. 42 – 2020) for the registration of the following medical devices:

  • Synchronized Cardioversion Device
  • Transcutaneous Pacemaker

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

Tagged under: medical device

What you can read next

New NMPA Measures for Random Medical Device Checking In-market
NMPA Issues Revised Guidelines for Legal Agent Responsibilities for Adverse Events
Next Big Step for the Introduction of Hong Kong Medical Devices to the Greater Bay Area

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