Register for Upcoming Webinar on Oct. 6 @ 11AM

NMPA Review Report Released for ViewRay’s MRIdian Linac System

Share:

The NMPA published 67 review reports from January to September 2022. Three categories are included: innovation, priority review and Class III predicate-comparison devices.

Overseas manufacturers including Boston Scientific, Edwards Lifesciences and Uptake Medical, ViewRay, etc. are on the list. Among them, ViewRay Incorporated, from California, gained approval for Magnetic Resonance-Guided Radiation Therapy, MRIdian Linac System, the first-of-its-kind, utilizing predicate-comparison pathway.

Product Description, Pre-clinical and Clinical

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.

MRIdian Linac System Product Overview

  1. Product structure and composition
  2. Scope of product application

This product is a magnetic resonance guided radiation therapy system, which provides conventional radiation therapy and body stereotactic radiation therapy guided by magnetic resonance scan images.

The magnetic resonance scanning system in this product is used for image guidance in radiation therapy, which can acquire images before, during and after radiation therapy in online/real time for planning radiation therapy, verifying the location of treatment targets and monitoring treatment Target movement. Magnetic resonance images obtained with this product are not intended for diagnostic purposes.

  • Model/Specification
  • Working principle

Pre-clinical

  • Product performance research
  • Physical and Mechanical Properties Research

Applicant submitted the product performance research data, the test report of the Beijing Medical Device Inspection Institute and self-test performance reports. Among them, the magnetic field strength, repeat positioning accuracy, body X-radiation radiotherapy stereotaxic and planning system, performance of some beam limiting devices, network security, head coil ghosting and spatial resolution are the self-test reports.

The applicant submitted the configuration table of medical device self-inspection equipment (including standard products/reference products), medical device self-inspection personnel information table, inspection-related quality management system documents list, and radiological compatibility study results.

  • Biocompatibility
  • Disinfection
  • Product validity period and packaging
  • Software research

The software complies with the “Guideline on Medical Device Software Registration” and “Guideline on Medical Device Network Security”

Clinical Evaluation of the MRIdian Linac System

The applicant chose the same-variety comparison for clinical evaluation. The selected products of the same variety are its previous generation product from the applicant, and medical linear accelerators from different manufacturer that have been marketed in China.

Compared with the previous generation product:

  • Different radioactive sources
  • Radiation therapy planning irradiation software adds linear accelerator beam delivery section, multi-leaf collimator

Compared with medical linear accelerators:

  • The imaging principles are different.

The applicant submitted the type test report, the benchmark/performance test report, the human body image data when the MRI sequence was added, the clinical data, and the clinical literature and analysis data of the same-variety products, etc. It has been shown that the differences do not cause negative effects in the usage.

Review Report List

Below is the list of devices with review reports issued in 2022. If you have similar devices entering China market, please contact us at info@ChinaMedDevice.com.

The list includes but not limited to the following:

  • Spinal cord nerve stimulation 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
  • Alpha and Beta Thalassemia gene detection kit (Combined probe-anchored polymerization sequencing)
  • Non-derivatized amino acid, carnitine, adenosine, lysolecithin and succinylacetone assay kit (tandem mass spectrometry)
  • SDC2 and TFPI2 gene methylation combined detection kit (fluorescence PCR method)
  • Hot steam therapy equipment
  • Disposable transbronchial endoscopic hot vapor therapy catheter
  • CT image-assisted triage software for intracranial hemorrhage
  • Ceftazidime/Avibactam concentration gradient agar diffusion sensitivity strip (concentration gradient agar diffusion method)
  • Hot steam therapy equipment
  • Disposable prostate hot steam treatment device
  • Mobile head and neck MRI system
  • 15 fusion gene detection kits related to leukemia
  • Digestive tract vibrating capsule system
  • Bracket positioning system
  • SHOX2/RASSF1A/PTGER4 gene methylation detection kit (PCR-fluorescent probe method)
  • patient monitor
  • Aldehyde and ketone reductase 1B10 assay kit (time-resolved fluorescence immunoassay)
  • Helicobacter pylori 23S rRNA gene and gyrA gene mutation detection kit (fluorescent PCR method)
  • Special puncture needle for radioactive seed implantation
  • Laparoscopic surgery system
  • Dual channel implantable deep brain stimulation pulse generator kit
  • Implantable deep brain stimulation electrode lead kit
  • Dual channel rechargeable implantable deep brain stimulation pulse generator kit
  • Implantable deep brain stimulation extension lead kit
  • Neurosurgery navigation and positioning system
  • Implantable spinal nerve stimulation extension lead
  • … …

Related Posts