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.
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
Below is the complete list of devices with review reports issued in 2022:
- 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
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- Source: https://chinameddevice.com/nmpa-review-reports-2022/