NMPA announced Recall Notices for 16 imported medical devices in November.
Class I recall (the most serious):
- Edwards Lifesciences: Aortic perfusion cannula
Class II and Class III recall:
- GE: Patient monitor
- GE: Endoscopic articular head linear cutting stapler and staple cartridge
- Johnson & Johnson: Wire-absorbable bone anchor system
- Johnson & Johnson: Diagnostic / Ablative elbow end catheter
- Philips: Defibrillator / Monitor
- Richard Wolf: Infusion pump
- Electro Medical Systems: Ultrasonic scaler
- Cook: Support catheter
- BioMérieux: Automatic fluorescence immunoassay analyzer
- Stryker: Tourniquet
- B. Braun: Vena cava filter and guiding system
- Intuitive Surgical: Endoscope surgery control system
- Elekta: Cancer information management
- Howmedica Osteonics: Joint surgery kit
- Instrumentation Laboratory: HemosIL von Willebrand factor antigen
For causes and model numbers of the recalls in November, please email info@ChinaMedDevice.com.
For Decree 29 Measures for the Administration of Medical Device Recall, please email us also. We charge nominal fees for the translation.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.