Two Implantable Resynchronization Cardioverter Defibrillators Got NMPA Nod

NMPA issued a notice summarizing device approvals in January 2023. In total of 23 imported Class II and III were approved, among them are implantable cardiac resynchronization cardioverter defibrillators from Abbott and St. Jude Medical.

Imported Class III

• Implantable cardiac resynchronization cardioverter defibrillator (Abbott)
• Implantable cardiac resynchronization cardioverter defibrillator (St. Jude Medical)
• Arteriovenous cannula (Medtronic)
• Single-use needle-proof venous blood collection device (Becton Dickinson)
• Cross-linked sodium hyaluronate gel (Anteis SA)
• Peripheral balloon dilation catheter (Boston Scientific)
• Cross-linked sodium hyaluronate gel (Q-Med)
• Titanium substrate and screws (Zfx GmbH)
• MEDICAL ANGIOGRAPHY X-RAY MACHINE (GE Medical)
• Ultrasound diagnostic system (ESAOTE)
• Sonographer (Supersonic Imaging)

Imported Class II

• Orthopedic drill (Medtronic)
• Disposable in vitro suction tubing (Micro Therapeutics)
• Verbroplasty assistive devices (Seawon Meditech)
• Single-use ophthalmic laser fiber (Quantel Medical)
• High-density lipoprotein cholesterol calibrators (Siemens)
• Fully automated enzyme-free analysis and fluorescence staining (INOVA Diagnostics)
• Electric anti-decubitus mattress (Care of Sweden AB)
• Mobile ECG atrial fibrillation prompt software (삼성전자)
• Wrist pulse oximetry (Nonin Medical)
• X-ray tube assembly (Varex Imaging)
• Catheter fixation devices (Argon Medical Devices)
• Seawater nasal sprayer (Jadran-Galenski laboratorij)

If you are interested in the approval pathway of any device above, please email info@ChinaMedDevice.com.

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• Source: https://chinameddevice.com/implantable-defibrillators-nmpa/