The NMPA released ninety-four review reports in 2022. Three categories of approvals are included: innovation, priority review and Class III predicate-comparison devices.
Overseas manufacturers including Boston Scientific, Edwards Lifesciences, Uptake Medical, ViewRay, etc. are on the list. Some utilized the Hainan Real-World Data pathway for their national approval.
Review our report on the ViewRay’s MRIdian Linac System
As the NMPA standardizes and streamlines the review process for fast-track approval, it is vital for manufacturers to comply with requirements of following items if you have similar equipment entering China market:
- Pre-clinical
- Clinical
- Risk-Benefit Analysis
Full List of the NMPA Ninety Four Review Reports 2022
Below is the complete list of devices with review reports issued in 2022. If you have similar devices entering China market, please contact us at info@ChinaMedDevice.com. We can translate the report with a nominal fee.
- Endovascular ultrasound diagnostic equipment
- Disposable endovascular ultrasound to diagnose catheter
- Disposable pressure monitoring magnetically positioned radiofrequency ablation catheter
- Artificial blood vessels
- Hepatitis B virus RNA (HBV-RNA) assay kit
- Drug-eluting coronary stent system
- Left atrial appendage occluder system
- Aspheric diffraction multifocal intraocular lenses
- Peripheral blood cell images, leukocyte-assisted recognition software
- Aspheric diffraction multifocal intraocular lenses
- Mycobacterial identification kit
- Septin9/SDC2/BCAT1 gene methylation assay kit
- Tuberculosis X-ray image-assisted evaluation software
- intracranial aneurysm flow diverter mesh stent
- Antiembolic cerebral protection system
- Patent ductus arteriosus occluder device
- Intracranial aneurysm surgical planning software
- Absorbable silk fibroin tissue-regeneration membrane
- Bone Morphogenetic Protein (BMP) bone graft
- Methylated Septin9/SDC2/BCAT1 DNA diagnostic Kit (PCR-Fluorescent Probe Method) (CSZ2000117).
- Integrated membrane oxygenator
- Proton therapy system
- Biolimus A9 drug-coated balloon
- Fundus imaging assisted diagnostic software for chronic glaucoma optic neuropathy
- Magnetic resonance imaging system
- Magnetic resonance guided radiation therapy system
- Medical adhesives
- Encephalitis/meningitis multi-pathogen nucleic acid combined detection kit (nested multiplexing of PCR melting curve assay).
- Human ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 methylated DNA assay kit (fluorescence PCR method).
- Anastomoses reinforcement patch
- absorbable oxidized regenerated cellulose hemostatic granules
- Electronic colonoscopic imaging assisted polyps detection software
- Single-use intravascular ultrasound diagnostic catheter
- Endovascular ultrasound diagnostic instrument
- ENT dual-source cone-beam computed tomography (CT) equipment
- Genetic analysis software for tumor tissue origin
- Implantable left ventricular assist device (LVAD) system
- Gamma-beam stereotactic radiation therapy system
- Tumor tissue origin gene detection kit (PCR fluorescent probe method).
- Gene sequencer
- prosthetic transcatheter pulmonary valve (TPV) system
- Cryoablation equipment
- Disposable cryoablation balloon catheter
- Laparoscopic surgical system
- Endoscopic Ultrasound (EUS) diagnostic equipment for gastrointestinal (GI) tract
- Endodontic surgery dynamic navigation system
- Magnetic resonance imaging system
- Positron emission X-ray computed tomography system
- Thoracic aortic stent system
- Single-use endovascular imaging catheters
- Endovascular imaging devices
- Patient-programmed charger
- Preimplantation chromosomal aneuploidy detection kit (semiconductor sequencing method)
- Implantable leadless transcatheter pacing system
- Human SFRP2 and SDC2 gene methylation combined detection kit (fluorescent PCR method).
- Single-use peripheral intravascular shockwave catheter
- Intravascular shockwave therapy equipment
- Single-use coronary intravascular shockwave catheter
- Six respiratory pathogens nucleic acid diagnostic kits (multiplex fluorescent PCR)
- Nitric oxide therapy device
- Spinal cord nerve stimulating test electrodes
- Knee replacement surgery navigation and positioning system
- Knee replacement surgery navigation and positioning system
- Iliac vein stent system
- Hip replacement surgery navigation and positioning system
- Magnetic resonance imaging system
- α and β Thalassemia Genetic diagnostic Kit (combined probe anchored polymerization sequencing).
- Non-derivatized amino acids, carnitine, adenosine, lysolithin, and succinylacetone assay kit (tandem mass spectrometry)
- Biological mesh for cardiac surgery
- SDC2 and TFPI2 gene methylation joint detection kit (fluorescent PCR method).
- Hot steam therapy equipment
- Disposable transbroncho endoscopic hot steam therapy catheter
- CT image aided triage software for intracranial hemorrhage
- Ceftadime/avibactam concentration gradient agar diffusion sensitive strip (concentration gradient agar diffusion method).
- Disposable prostate hot steam therapy device
- Hot steam therapy equipment
- Leukemia-related 15 fusion gene detection kit (fluorescent RT-PCR method).
- Mobile head to neck magnetic resonance imaging system
- Digestive tract vibrating capsule system
- Stent positioning system
- SHOX2/RASSF1A/PTGER4 Gene Methylation Diagnostic Test Kit (PCR-Fluorescent Probe Method)
- Patient monitors
- Helicobacter pylori 23S rRNA and gyrA diagnostic test kit for gene mutation (fluorescent PCR method)
- Aldehyde ketone reductase 1B10 assay kit (time-resolved fluorescence immunoassay).
- Radioactive seed implantation needle
- Laparoscopic surgical system
- Dual-channel implantable deep brain stimulation pulse generator kit
- Implantable deep brain stimulation extension lead kit
- Dual-channel rechargeable implantable deep brain stimulation (DBS) pulse generator kit
- Implantable deep brain stimulation (DBS) electrode lead kit
- Implantable spinal cord nerve stimulation extension lead
- Neurosurgical navigation and positioning system
- Implantable spinal cord nerve stimulation electrode
- Implantable spinal cord nerve stimulation electrode