China NMPA Releases The Results Of Medical Device Sampling Inspections
2023-08-30
In order to strengthen the supervision and management of medical devices, and ensure that the quality of medical device products is safe and effective, NMPA usually conduct sampling inspection on medical devices in China. Recently, NMPA organized a product quality supervision and sampling inspection on five varieties of medical devices, including dental low voltage electric motors, patches (far infrared therapeutic patches, magnetic therapy patches, acupoints magnetic therapy patches). As per the sampling inspection results, a total of 12 lots (units) of products do not comply with the standards.
The followings are the details on the non-compliances of medical devices:
Dental low-voltage electric motor, involving leakage current and patient-assisted current (at operating temperature) and no-load speed not complying with the standard.
Vertical pressure steam sterilizer, involving permissible limits of accessible parts and components under normal conditions, and the limit of a single fault condition not complying with the standard.
Electric suction device, involving the mains-driven, mobile high negative pressure / high flow rate equipment not complying with the standard.
Patch medical devices (far-infrared therapy patch, magnetic therapy patch, acupoint magnetic therapy patch), involving the non-detection of the relevant drug ingredients in accordance with the supplemental test method not complying the requirement.
Human blood and blood components bag-type plastic containers (blood bags), involving blood bags transfusion socket not complying the standard.
For the above non-complying products found in the sampling, NMPA has requested the local drug supervision and management departments (local NMPA) to make timely administrative decisions and release to the public. The manufacturers should conduct the risk assessment, do relevant recalls, find out the reasons for non-complying products and make corrections in time.
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