• 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
  • Supervision and administration of medical device – sampling inspections finds 12 product failures

Supervision and administration of medical device – sampling inspections finds 12 product failures

Supervision and administration of medical devices
Wednesday, 02 November 2022 / Published in Medical Device, News, NMPA Registration in China

Supervision and administration of medical device – sampling inspections finds 12 product failures

The supervision and administration of medical devices through sample inspections in China are frequently used by the National Medical Products Administration (NMPA). In this way, the NMPA ensures the quality, safety and effectiveness of medical devices that are placed on the market. In this instance the NMPA organized a sampling inspection of 12 varieties of products, including electric wheelchairs, and found that 26 batches (sets) of products did not meet the prevailing product standards.

List of medical devices that were found not to conform

Below you will find the medical device products that were found not to conform with the standard and the reasons why:

1. Electric wheelchairs: the minimum radius of gyration, the inhibition of driving while charging, the maximum speed, the horizontal road braking, the maximum safe slope braking do not meet the standard provisions.

2. Pneumatic belly machine: the continuous leakage current at normal operating temperature does not meet the standard provisions.

3. Metal spine bar: surface roughness does not meet the standard provisions.

4. The metal bone plate: bending strength and equivalent bending stiffness, does not conform to the standard.

5. The Nd: YAG laser therapy machine: the accuracy of control devices and instruments, and the pulse energy/pulse string energy of the laser terminal do not conform to the standard.

6. The gynecological ultrasonic diagnostic equipment: the detection depth and blood flow velocity error in Doppler mode do not conform to the standard.

7. The portable X-ray machine: the input power, the half-price layer of the X-ray equipment, and the distance from the focus to the skin do not conform to the standard.

8. Dental implant machine: no-load speed does not meet the standard.

9. The disposable abdominal puncture device: gas resistance and sealing performance, and the matching performance do not meet the requirements of the standard.

10. Surgical clothes: bursting strength-dry state (product critical area), bursting strength-dry state (product non-critical area), bursting strength-wet state (product critical area), breaking strength-dry state (product critical area), breaking strength-dry state (product non-critical area), fracture strength-wet state (product critical area), microorganism penetration-dry state (product non-critical area) do not meet the standards.

11. Single-use human venous blood sample collection containers: nominal liquid volume, scale markings and filling line, sterility do not meet the standard provisions.

12. Cold light source for endoscopy: continuous leakage current at normal operating temperature, input power, samples in the normal inspection process cannot be used normally, the relevant color temperature, red, green and blue light irradiation flux ratio do not meet the provisions of the standard.

Implications for medical device manufacturers

  • All of the above medical devices were notified that their products have failed the sampling inspection. The failures were due to the domestic or foreign medical device manufacturing company’s own problems in meeting standards or technical requirements; these failures were not related to an upgrading of standards.  If quality standards or technical requirements of sampled products do not meet the relevant provisions of the National Medical Products Administration (NMPA), this means the products have failed the sampling. The NMPA Legal Agent will receive a notification letter from the NMPA about their product failing sampling. The NMPA Legal Agent should forward the letter and inform and instruct the MD manufacturer about the next steps following the sampling inspection failure.
  • Medical device manufacturers should clarify the details of the NMPA ‘s standards and technical requirements for their products during the registration process to avoid any problems of inconsistency between the specifications of the products and the regulations of the NMPA.

As a legal agent, we explain and clarify relevant NMPA regulations and standards to our clients to ensure they remain fully compliant post-market.

Further information

Please click here for the full list of products that do not meet the standard in this latest sampling inspection.

Read about the NMPA’s sampling inspection plan for 2022 here.

Read about the standard working procedure for medical device quality spot inspections here.

And if you would like more information on our registration and CRO services for pharmaceuticals, medical devices, IVDs, cosmetics, health foods, and industrial or consumer goods, please contact us.

GET IN TOUCH

🌐 Send us your enquiry
📚 Request our whitepapers
📣 Sign up for our newsletter

Tagged under: inspections, medical device, NMPA, standards

What you can read next

Measures for the administration of drug registration
Measures for the Administration of Drug Registration in China
NMPA Solicits Public Opinions on the Reclassification of IVD Reagents
Medical Device Supplementary Notice Period
China’s Medical Device Supplementary Notice Period reverts to a one-year period

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

  • GB9706 standards for medical electrical equipment

    GB9706 standards for medical electrical equipment – implementation details clarified

    GB9706 standards are important reference guidel...
  • Microbial limits for non-sterile chemical drugs

    Microbial limits for non-sterile chemical drugs, API and excipients – new guidelines issued

    Microbial limits for non-sterile chemical drugs...
  • Medical Device Supplementary Notice Period

    China’s Medical Device Supplementary Notice Period reverts to a one-year period

    China’s Medical Device Supplementary Notice Per...
  • Dental adhesive products registration review guidelines

    Dental adhesive products registration review guidelines issued by the CMDE

    Dental adhesive products registration review gu...
  • China’s Toothpaste Supervision & Administration Regulation

    China’s New Toothpaste Supervision & Administration Regulation: A brief guide

    China’s Toothpaste Supervision & Administra...

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