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
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.
