• 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
  • CMDE Compares EU and China Risk Management

CMDE Compares EU and China Risk Management

Monday, 23 August 2021 / Published in Medical Device, News, NMPA Registration in China

CMDE Compares EU and China Risk Management

On August 6, 2021, the CMDE (Center for Medical Device Evaluation) of the NMPA (National Medical Products Administration) released an overview to compare the latest medical device risk management requirements between China and the EU.

Background

Since 2014, the medical device registrants in China have been referring to the requirements of risk analysis information in the NMPA announcement (No.42-2014) whilst, on the other hand, the YY/T 0316-2016 is the current effective medical device risk management standard in China.

On May 25, 2017, the EU Medical Device Regulation (hereinafter referred to as “the MDR”) (No.745-2017) came into force with a 3-year transition period. However, due to the covid-19 pandemic, the implementation date of the MDR was delayed by a year to May 26, 2021. In 2019, the ISO 14971:2019 was published by the International Organization for Standardization (ISO) as the 3rd edition of the risk management standard for medical devices, and adopted as the harmonized standard EN ISO 14971:2019 in the EU.

Highlights

The CMDE addressed the similarities and differences based on five major aspects:

Negligible risks

The MDR states that risk control measures should be applied to all identified risks whilst the NMPA announcement (No.42-2014) requires the benefits to always outweigh the risks during the normal use of medical devices; both countries require that all risks should be minimized to an acceptable level.

Risk/benefit analysis

The EU requires much more in-depth input from the manufacturers in terms of risk/benefit analysis than China.

Notification of residual risks

According to the China YY/T 0316-2016 standard, the decision of the disclosure of residual risks is up to the manufacturer. However, the MDR requires manufacturers to inform users for all residual risks in EU.

Risk control measures

According to the China YY/T 0316-2016 standard, there are three risks classifications: Acceptable Risks, Unacceptable Risks, and As Low As Reasonably Practicable (ALARP).
According to the EU and ISO 14971:2019 standards, there are only two risk classifications: Acceptable Risks and Unacceptable Risks.

Target audience of risk management documents

The EU MDR requires manufacturers to establish and maintain a risk management plan for each device, while the China YY/T 0316-2016 standard does not require a separate documentation for each device.

In summary, due to the recent launch of the EU MDR, the CMDE identifies that the current risk management requirements in EU is comparatively stricter than in China for medical devices. Risk management documents that meet the EU requirements can generally meet the Chinese requirements, but not vice versa. This could mean that there will be a higher success rate of application approvals for EU compliant medical devices registering in China.

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

Tagged under: EU MDR, risk analysis, risk control, risk management

What you can read next

Medical Device Electronic Submission System (eRPS)
China’s Toothpaste Supervision & Administration Regulation
China’s New Toothpaste Supervision & Administration Regulation: A brief guide
CSAR Launched and New Regulatory Controls on Cosmetics

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

  • Submission of safety information for cosmetics ingredients

    Submission of safety information for cosmetics raw materials – Draft guidelines issued

    Submission of safety information for cosmetics ...
  • avoid animal testing in Chinaweb-2023

    How to avoid animal testing in China for cosmetics | Cisema Webinar

    China’s beauty and cosmetic market has be...
  • guidelines for medical devices registration

    Guidelines for medical devices registration in China – New development plans in 2023

    Guidelines for medical devices registration in ...
  • China DMF of API

    China DMF of API, Excipient & Packaging Materials: Market & Regulatory | Cisema Webinar

    “China DMF of API, Excipient & Packag...
  • pre-phase III drug clinical trial meeting guidelines

    Pre-phase III drug clinical trial meeting guidelines released

    Pre-phase III drug clinical trial meeting guide...

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