Results of Sampling Inspection on Medical Devices Released

On September 15, 2021, NMPA issued the results of sampling inspection on medical devices. A total of 12 varieties, including semiconductor laser therapy machine, nasal endoscope and surgical clothes, were subject to product quality supervision and sampling inspection, of which 23 batches (sets) of products failed to meet the standards.

Major Results of Sampling inspection are as follows:

I. Medical devices with sampling inspection items failing to meet the standards

1. Four sets of semiconductor laser therapy machines: the operation instructions, external marks of equipment or equipment parts, output power of laser terminal, pulse duration (pulse width) and laser timing device do not meet the standards.
2. Two sets of nasal endoscopes: the color resolution, color reduction and comprehensive lens light effect do not meet the standards.
3. One ultrasonic Doppler blood flow analyzer: the external marks of the equipment or equipment components do not meet the standards.
4. One root canal preparation machine: the indicator light and button do not meet the standards.
5. Two batches of endotracheal intubation: cuff (filling diameter) and sterility do not meet the standards.
6. One Batch of soft contact lenses: It involves the total diameter, base arc radius or sagittal height of a given bottom diameter do not meet the standards.
7. Two batches of disposable ureteral stents: fixation strength (before immersion) and elongation (before immersion) do not meet the standards.
8. One batch of disposable sterile surgical film: the water vapor permeability does not meet the standards.
9. One set of medical ultrasonic atomizer: the external marks of the equipment or equipment components do not meet the standards.
10. Three infusion pumps (syringe pump, analgesic pump and insulin pump): audible and visual alarm, and audible indication that must precede the end of infusion do not meet the standards.

The production safety of medical devices is particularly important, and supervision over the whole life cycle from development, production to use and scrapping should be implemented. Those who do not meet the standards shall be recalled by manufacturers.

Provisions for Recall of Medical Device has made the following requirements for medical device manufacturers:

• Establish and improve quality management system and adverse event monitoring system of medical device
• Collect and record quality complaints and adverse events of medical device
• Analyze the collected information and investigate and evaluate possible defects
• Timely report the collected medical device adverse event information to NMPA
• Cooperate with NMPA to analyze and investigate the medical device adverse event or possible defects

Brady employees have extensive experience in the life-cycle management of medical devices. Contact us (info@inspirativemed.com) for more information about China market access compliance, PMS/QMS, etc.