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.
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.
China Med Device, LLC can help you design the electronic file for SDA (CFDA) compliance labels in Chinese. In addition, we can help and implement these labels on the products to meet SDA requirements. Please email info@ChinaMedDevice.com for more information.
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About China Med Device, LLC
China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 200+ companies' success.
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------