Register for Upcoming Webinar on DEC. 8 @ 11AM

New white paper available now!

These Class III Devices Exempted for Clinical Trial: Cardio/Neurosurgery, Radiation, Imaging, Ophthalmology and More

Share:

nmpa guidelines for nanomaterials

NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on June 16, 2022. The document suggests manufacturers how to choose clinical evaluation exemption, predicate device comparison or clinical trial. Wide range of Class III devices in the fields of neurosurgery and cardio surgery, radiation therapy, medical imaging, ophthalmology, obstetrics, and assisted reproduction are affected.

The clinical recommendations are based on the “Guideline on Decision Making of Conducting Clinical Trial for Medical Devices” published in September 2021. The recommendations for active and non-active devices are issued HERE.

Clinical Trial Exemption List

NMPA agrees that the following Class III devices can choose clinical evaluation exemption or predicate-device comparison pathway, instead of lengthy and costly clinical trial. The composition and the intended use are explained for each device:

Neurosurgery and Cardio Surgery

  • Myocardial biopsy forceps
  • Angiography catheter
  • guide catheter
  • central venous catheter
  • perfusion catheter
  • Ring handle syringe
  • extension tube
  • microcatheter
  • Shunt plug
  • Cardiac occluder delivery cable
  • Endovascular retrieval device
  • remote protector
  • cutting balloon
  • contrast balloon
  • occlusion balloon
  • thrombus aspiration catheter
  • trocar peripheral catheter

Radiation Therapy

  • Medical electron accelerator
  • Medical X-ray Therapy Equipment
  • Gamma beam teletherapy machine
  • Brachytherapy equipment
  • Radioactive Seed Implant Therapy System
  • Radiation Therapy Simulation System
  • X-ray image guidance system for radiotherapy
  • Electron Portal Imaging System
  • Ultrasound Image Guidance System
  • Electromagnetic positioning system
  • Optical Positioning Guidance System
  • X-ray Radiation Therapy Stereotactic System
  • Collimation beam limiting device
  • beam scanning measurement system

Medical Imaging

  • Angiography X-ray machine
  • Oral X-ray machine
  • Fluoroscopy X-ray Machine
  • Contrast injection device
  • Puncture positioning guide device
  • Contrast injection device
  • Magnetic Resonance Imaging Equipment (MRI)
  • Optical imaging diagnostic equipment

Ophthalmology

  • Laser Diagnostic Equipment
  • Endoscopes and accessories
  • Ophthalmic surgical aids

Obstetrics and assisted reproduction

  • Urethral hanger
  • Pessary
  • In vitro assisted reproductive fluid
  • Special equipment for assisted reproduction

View our service page of Clinical Evaluation Report (CER)

Watch our recorded webinar on “China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739

Leading companies

The clinical pathway recommendations involve a wide range of manufacturers. China Med Device, LLC suggest the following companies to be informed with the recommendations.

Cardio surgery

  • Medtronic
  • St. Jude Medical
  • Boston Scientific
  • Edwards Lifesciences
  • Abbott Laboratories
  • Johnson & Johnson
  • Getinge
  • Terumo

Neurosurgery

  • GE Healthcare
  • Medtronic
  • Natus Medical
  • NIHON KOHDEN
  • CAS Medical Systems
  • Clinical Science System
  • Nonin Medical
  • Tristan Technologies
  • Masimo

Radiation therapy

  • Varian Medical Systems
  • Elekta
  • Becton, Dickinson
  • Nordion
  • Accuray
  • IsoRay
  • Ion Beam Application
  • Curium Pharma
  • ViewRay
  • Mevion Medical Systems

Ophthalmology

  • Alcon
  • EssilorLuxottica
  • Johnson & Johnson Vision
  • Bausch + Lomb
  • Hoya Corporation
  • Carl Zeiss AG
  • CooperVision
  • Topcon