• 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
  • China Regulatory Round-up for Medical Devices in November and December 2020

China Regulatory Round-up for Medical Devices in November and December 2020

Friday, 22 January 2021 / Published in Medical Device, NMPA Registration in China

China Regulatory Round-up for Medical Devices in November and December 2020

China Regulatory Guidelines Issued / Updated

1 GB (Guobiao) mandatory standard for transfusion sets will be implemented on June 1, 2022, whilst 2 GB mandatory standards for medical electrical equipment will be implemented on May 1, 2023.

The NMPA issued regulatory guidelines (including drafts) for 16 medical devices throughout November and December 2020:

  • Technical review guidelines for household in-vitro diagnostic devices
  • Technical review guidelines for specific protein immunoassay devices
  • Technical review guidelines for prolactin detection reagents
  • Technical review guidelines for total triiodothyronine detection reagents
  • Technical review guidelines for 25 hyrdroxyvitamin D detection reagents
  • Technical review guidelines for serum amyloid A detection reagents
  • Technical review guidelines for rheumatoid factor detection reagents
  • Technical review guidelines for nomenclature of orthopaedic surgical instruments
  • Technical review guidelines for nomenclature of blood transfusion, dialysis and cardiopulmonary bypass devices
  • Technical review guidelines for nomenclature of passive surgical instruments
  • Technical review guidelines for nomenclature of passive implantable devices
  • Technical review guidelines for nomenclature of disinfection and sterilization devices
  • Technical review guidelines for electronic upper gastrointestinal endoscope
  • Technical review guidelines for fundus camera
  • Technical review guidelines (draft) for biodegradable magnesium orthopaedic implants
  • Technical review guidelines (draft) for the use of in-vitro diagnostic reagents overseas clinical trial data

China Fast-Track Approval Updates

Amongst the applicants of the 5 medical devices pending for registration approval via the Special Review Procedure for Innovative Medical Devices, the application of the intraocular lens was submitted by Alcon Laboratories, Incorporated, an American-Swiss medical company specializing in eye care products.

The Hepatitis B virus PCR fluorescence quantitative detection kit is pending for registration approval via the Procedure for Prioritized Review, and considered as a major project in China’s national science and technology field. The applicant is a local manufacturer in Suzhou, China.

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

Tagged under: fast-track approval, Guobiao, Medical Devices, Prioritized Review, Special Review Procedure, Technical Review Guidelines

What you can read next

New Guidelines for Sterile Medical Devices
NMPA Technical Review Guidance Draft for Personalized Implants for Additive Manufacturing
Public Consultation on the Measures of Review Management on Advertising for Health Food, FSMP, Drug Products and Medical Devices

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