Shanghai CFDA office released Medical Device Half Year Recall Report on July 20. Total 165 medical devices have been voluntarily recalled in Shanghai for the first half of 2018, including 154 imported devices (93%) and 11 domestic devices (7%). Foreign manufacturers include Roche, Siemens, GE, Philips, Abbott, Becton Dickinson, Boston Scientific, Smith &Nephew, etc.
The number of voluntary recalls in the first half of 2018 was increased by 66.7% year-on-year.
For a complete list of manufactures and the model numbers, please email info@ChinaMedDevice.com
All the recalls were classified by category, severity of defects and reason:
Category – 100 active devices, 37 passive devices, and 28 IVDs
Severity of defects – 3 class I recall, 52 class II recall, and 110 Class III recall
Reason – 80 design defects (48%), 50 manufacturing issues (30%), 29 labeling problems (18%) and 6 others (4%)
Four (4) recommendations were given by Shanghai CFDA:
- Manufacturer should pay attention to the risk of blood glucose strip defects, because one of the 3 class I recalls were for blood glucose strip and the strip has insufficient enzyme content that affects the test results.
- Pay attention to the bacterial endotoxin risk of sterile products. One class I recall involved in detectable level of bacterial endotoxin on the product package, which may cause cross infection.
- Pay attention to the power failure of active implants. One class I recall, a cardioverter defibrillator, was due to the dismal battery performance after firmware upgrade.
- Focus on the labeling. The number of labeling errors increased, up 93% year-on-year, mainly due to incorrect registration numbers.
China Med Device, LLC is experienced in handling inspection. We can help you meet with GMP requirements and design the electronic file for SDA (CFDA) compliance labels in Chinese. Please email info@ChinaMedDevice.com for more information.
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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 certified as a legal agent. 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.