【NMPA】The results of Sampling Inspection of Medical Device Supervision (No.5)

In order to strengthen the supervision and administration of medical devices, ensure the safety of medical equipment product quality effectively, the state drug administration organization of customised fixed denture, medical oxygen concentrator (medical oxygen generator), specific electromagnetic therapeutic apparatus, and 11 varieties of product quality supervision and sampling, a total of 52 (Taiwan) products do not conform to the prescribed standards. The details are announced as follows:

I. Medical device products that are not in conformity with the standards of the sampled items:

• 6 batches of customised fixed denture:production, provisions relating to porosity does not conform to the standard.
• 3 batches of abdominal puncture apparatus: involve hardness (if applicable) and mating performance that do not meet the standards.
• One high-frequency surgical equipment: the samples cannot be normally used during the inspection and do not conform to the standards and regulations.
• Acetabular lining: Batch 1: Dimensions and tolerances related to joint surface are not in conformity with standards.
• Three slit lamp microscopes:the external marks of the equipment or its components are not in conformity with the standard provisions.
• One RADIofrequency ablation catheter: involving DC resistance that does not meet the standards and regulations
• 2 infusion pumps (injection pump, analgesia pump, insulin pump) : the accuracy of audible alarm signals and working data does not meet the standards and regulations.
• 11 sleep apnea therapy equipment: relating to the equipment or equipment parts external markers, operating instructions, technical manuals, maximum pressure limit, data accuracy is not in conformity with the prescribed standards.
• specific electromagnetic therapeutic apparatus 5: production, relating to the equipment or equipment parts external markers, lights and buttons, random file, and the supply network breaking, controller and the instrument tag, soft power supply wire, indicator, the operation of the controller components, protective parts do not conform to the prescribed standards.
• One-time use of portable infusion pump non-electric drive 1 batch: involving accuracy (flow) does not meet the standard provisions.
• medical oxygen concentrator (medical oxygen generator) 18 units: the production, Concerns with vibration and noise, oxygen concentration, input power, labeling of controllers and meters, external labeling, enclosure closure, safety of enclosures and doors that can be opened without tools, continuous leakage current, and patient assisted current (at normal operating temperatures) do not meet standard requirements.