On June 22, CFDA published Quality Notice #47 and identified 64 defects for 9 types of medical devices: nerve and muscle stimulator, ultrasonic atomizer, disposable vaginal dilator, insulin pimp, oxygen concentrator, maxillofacial X-ray, surgical needle, etc. Some affected devices are to be voluntarily recalled by manufacturers.
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All the observations were classified by the following reasons:
23 labeling issues, 21 design issues, 12 management problems and 6 record deviations and 2 manufacturing defects.
Among the devices with labeling issues, 3 imported ones were affected:
Topcon (Japan): refractometer
Marutakatech (Japan): high frequency electron apparatus
PaloDEx (Finland): maxillofacial X-ray
CFDA started to publish Medical Device Quality Notice since February 2016 to improve the quality system and post market compliance of manufacturers in China. A total of 47 notices have been issued in 2 and a half years.
It should be noted that the post-market surveillance, including sampling, inspection and supervision of Corrective and Preventive Action (CAPA), are carried by local CFDA offices where the manufacturers are registered.
Shanghai quarterly recall report published in early April showed 15% recalls have labeling issues.
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