The NMPA issued a notice summarizing device approvals in January 2023. In total of 23 imported Class II and III were approved, among them are two 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.
About China Med Device and Implantable Defibrillators NMPA
China Med Device provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China.
Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, IVDs draft guidelines, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.