• 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
  • NMPA issues updated guidance for registration of AI software to assist with responding to the Corona-virus pandemic

NMPA issues updated guidance for registration of AI software to assist with responding to the Corona-virus pandemic

Monday, 04 May 2020 / Published in Medical Device, News

NMPA issues updated guidance for registration of AI software to assist with responding to the Corona-virus pandemic

Due to shortages of qualified medical staff and consistent with the Chinese government’s emphasis on AI technology, the NMPA has made a number of announcements providing guidance on the registration process for AI software in the healthcare sector. The most recent was in March 2020 to provide an assessment framework for product registration of Corona-related diagnostic software.

Large Chinese companies such as Tencent have also been heavily investing in AI software in the fight against Corona virus, as reported here in Chinese newspapers recently.

Software that assists with curative or diagnostic processes in China generally must be registered as a medical device with the NMPA. China has two kinds of license for AI medical devices: (1) assistive products, being those which aid healthcare professionals in their provision of care to patients; and (2) diagnostic products, being those that assist with determining the cause of an ailment.

On 05.03.2020, the Center for Medical Device Evaluation of NMPA (National Medical Products Administration) released (No.8-2020) the assessment framework for the product registration of pneumonia diagnostic software in China. The assessment applies to SaMDs (software as a medical device) adopting deep learning technology to evaluate chest CT scans, to assist triage and to diagnose clinical cases affected by the Covid-19 pandemic.

According to the NMPA, this type of software product is classified as a Class III medical device, and the software security level is B. The assessment framework advises manufacturers to focus on, but not limited to, the following requirements for the preparation of research data and supplementary materials:

Basic functions

The software should at least cover one of the following functions: 

  • Anomaly detection
  • Quantitative analysis (For example: Lesion volume ratio, CT value distribution, etc.)
  • Data comparison (Manual or automatic)
  • Report output

Anomaly detection is used for the triage of suspected cases, whilst quantitative analysis and data comparison are used for the diagnosis of confirmed cases.

Data for Machine Learning

  • The chest CT scan images of a minimum of 2000 Covid-19 patients
  • Must be sourced from three medical institutions, and one of the medical institutions must be located in a Covid-19 heavily-affected area
  • Must include the chest CT scan images of the initial and advanced stage of confirmed Covid-19 cases

Data Distribution

The data distribution of Covid-19 information based on the following factors:

  • Demographics (For example: Gender and Age)
  • Stages (Initial, advanced, and severe) of the chest CT scan images
  • Data sourcing companies
  • CT scan equipment (For example: Manufacturer and Layer thickness)

For SaMDs adopting traditional machine learning technology, the manufacturers are advised to refer to another assessment framework (No.7-2019) released by the CDME on 03.07.2019. This assessment framework applies to the product registration of SaMDs using deep learning and traditional machine learning technologies to assist medical staffs in making clinical decisions.

Both traditional machine learning and deep learning technologies are a subset of AI, however, the former normally requires human intervention for the feature extraction process, whilst the latter automatically completes the feature extraction process itself. The assessment framework addresses the basic principles of evaluating the risks, benefits, safety and effectiveness of the SaMD throughout its product lifecycle to ensure the pre-market and post-market regulatory requirements have been met.

By Hamish King. Contact Hamish or Cisema to learn more.

Tagged under: AI, AI medical devices, deep learning, machine learning, SaMD, Software

What you can read next

2019 Annual Report, Strengthening Scheme and Updates on Medical Device Mandatory Standards
Webinar: Medical Devices in China
cosmetics-gmp
Cosmetics GMP Good Manufacturing Practices now in force in China

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

  • Physicochemical characterization of nanomaterials

    Physicochemical characterization of nanomaterials used in medical devices – New guidelines issued

    Physicochemical characterization of nanomateria...
  • Registration of disposable light-proof infusion sets in China

    Registration of disposable light-proof infusion sets in China – Amended guidelines issued

    Registration of disposable light-proof infusion...
  • Registration of disposable blood separation devices in China

    Registration of disposable blood separation devices in China – Amended guidelines issued

    Registration of disposable blood separation dev...
  • Registration of disposable infusion devices in China

    Registration of disposable infusion devices in China – Amended guidelines issued

    Registration of disposable infusion devices in ...
  • Registration of blood dialyzers in China

    Registration of blood dialyzers in China – Amended guidelines issued

    Registration of blood dialyzers in China shall ...

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