• 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
  • 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
  • About us
    • Partners
    • Company Profile
    • Testimonials
  • Locations
  • Newsletter Sign Up
Contact
  • Home
  • News
  • News
  • NMPA Registration in China
  • Medical Device
  • April 2021 China Regulatory Round-up for Medical Devices

April 2021 China Regulatory Round-up for Medical Devices

Friday, 23 April 2021 / Published in Medical Device, News, NMPA Registration in China

April 2021 China Regulatory Round-up for Medical Devices

On April 9, the TC94 (National Technical Committee for Standardization of Surgical Instruments) has announced the completion of its draft for the general requirements and test method for surgical instruments – non-cutting, articulated instruments. The TC94 is currently soliciting public comments until June 10, 2021.

On April 12, the NMPA (National Medical Products Administration) issued (No.25.2-2021) a report for conducting sampling inspection on 9 product categories covering electric wheelchairs, soft contact lenses, and disposable nasal oxygen cannula.

The following 55 products did not meet the standard requirements:

  • 15 electric wheelchairs
  • 7 soft contact lenses
  • 1 electrical nerve and muscle stimulation machine
  • 6 infusion pumps
  • 1 optometry examination equipment
  • 5 disposable nasal oxygen cannulas
  • 7 medical electronic thermometers
  • 8 medical oxygen concentrators
  • 5 medium frequency electrotherapy equipment

On April 15, the NMPA issued (No. 24 – 2021) the technical guidelines for the registration of 5 medical devices:

  • Technical Guidelines for the Registration of Tumor Companion Diagnostic Reagents Based on Similar Therapeutic Drugs
  • Technical Guidelines for the Registration of Real-time Fluorescent PCR Analyzer
  • Technical Guidelines for the Registration of Rotavirus Antigen Detection Reagents
  • Technical Guidelines for the Registration of Group B Streptococcus Nucleic Acid Detection Reagents, and
  • Technical Guidelines for the Registration of Human Parvovirus B19 IgM/IgG Antibody Detection Reagents

The CMDE (Centre for Medical Device Evaluation) of the NMPA announced their plans to formulate the following technical guidelines for:

  • The clinical evaluation of gene sequencers (Announced on April 12, 2021)
  • The survival of motor neurons Gene 1 (SMN1 gene) testing reagent (Announced on April 12, 2021)
  • The design of clinical reproducibility studies of PD-L1 detection reagents (Announced on April 12, 2021)
  • The microsatellite instability (MSI) detection reagents for clinical trials (Announced on April 12, 2021)
  • The registration application materials for quality control test reagents (Announced on April 14, 2021)
  • The performance evaluation of Human Immunodeficiency Virus Antigen and Antibody Detection Reagents (Announced on April 15, 2021)

The CMDE is also asking for the public input from manufacturers and related companies to support the writing of the above-mentioned technical guidelines.

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

What you can read next

Technical guidelines for reporting cosmetics formulas
Technical guidelines for reporting cosmetics formulas – draft issued
Prolonged Deadlines for the Renewal of NMPA Registration for Cosmetics
Changes of Health Food Functions Claims

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

  • Children cosmetics technical guidelines in China

    Children cosmetics technical guidelines in China – Newly issued by NIFDC

    Children cosmetics technical guidelines in Chin...
  • pH Determination Method

    China’s cosmetic safety technical specifications – 21 revision items issued

    China’s cosmetic safety technical specifi...
  • laser therapy devices

    Clinical evaluation of laser therapy devices – New guidelines issued

    Clinical evaluation of laser therapy devices ha...
  • dental implant system

    Clinical evaluation of dental implant systems in China – New guidelines issued

    Clinical evaluation of dental implant system ha...
  • China Medical Device Webinar

    China Medical Device Webinar with AdvaMed Accel for U.S. exporters

    The China Medical Device Webinar will be featur...

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

© 2003-2023 Cisema. All rights reserved.

TOP