China medical device sampling inspection results no.4 of 2022 have been released by the National Medical Products Administration (NMPA).
The NMPA organized product quality supervision and sampling inspections on 10 varieties of medical devices including electric wheelchairs, small steam sterilizers, and uric acid assay kits. The sampling inspection found that 29 batches (units) of products did not meet the standard regulations.
Manufacturers of medical devices should strengthen the management and supervision of product quality and safety. If the product quality of the medical device/in vitro diagnostic reagent (IVD) does not meet the standard regulations, NMPA will announce this information to the society and the manufacturer needs to conduct a product risk assessment.
In serious cases, the medical device/IVD will be recalled.
Products that did not meet the standard regulations and related non-compliant items in no.4-2022
- Electric wheelchairs (10 units): inhibited driving during charging; input power; continuous leakage current and patient auxiliary current at normal operating temperature; maximum speed; braking on horizontal road surface; braking on maximum safe slope; input power.
- Small steam sterilizer (1 set): balance time; maintenance time; steam temperature for maintenance time.
- Uric acid assay kit (1 batch): accuracy.
- X-ray bone densitometer (1 unit): X-ray tube voltage accuracy.
- Dental implant machine (1 unit): no-load speed
- Cold light sources for endoscopes (6 sets): the radiant flux ratio of red, green and blue light, infrared cut-off performance, input power, and samples that cannot be used normally during the normal inspection process.
- Alginate Dressing (Batch of 2): Diffuse.
- Contrast medium injection device (1 set): maximum injection pressure.
- Surgical gown (3 Batches): sterile.
- Sodium hyaluronate gel for injection (3 batches): content of free sodium hyaluronate
Actions taken by NMPA and provincial Medical Product Administrations (MPA) on products that did not meet the standard regulations
- The NMPA requires provincial MPAs where the medical device registrants are located to make an administrative decision in a timely manner and announce it to the public.
- Provincial MPAs will inform medical device registrants to conduct risk assessments for products that do not meet the standards in random inspections. The MPA will also determine the recall level according to the severity of medical device defects, actively recall products and disclose recall information. Provincial MPAs will inform companies to find out the reasons for the unqualified products as soon as possible, formulate corrective measures and implement the corrective measures on schedule.
Next steps
Manufacturers should work with their NMPA Legal Agent to ensure that their products comply with all relevant standards, for example all electrical medical equipment should be preparing to meet the new standard GB9706.1-2020 which comes into force on May 1, 2023 (please refer to this link for further information).
Further information
Click here to read the China medical device sampling inspection results no.4 of 2022.
If you would like to check the compliance of your products with relevant standards, please contact us.
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