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More Class II & III Medical Devices to be Exempted from Clinical Trial

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The NMPA published the draft version of “Clinical Trial Exemptions Catalog for Medical Devices” on July 5, 2022, for feedback. It is an effort to implement risk-based clinical evaluation, and to make medical device clinical exemptions more consistent with internationally accepted standard, NMPA stated in the notice.

Ask us if your devices are in the proposed catalog. Even if not, we can develop clinical evaluation strategy to help you avoid the expensive and time-consuming clinical trial. info@ChinaMedDevice.com.

Eleven medical devices are added to the proposed catalog:

  • Disposable intracranial retraction and fixation catheter
  • Neuromonitoring endotracheal intubation
  • Medical Air Compressor
  • Negative Pressure Assisted Venous Drainage Controller
  • Single/multi-part prefabricated cranioplasty plates and fasteners
  • Negative pressure drainage sealing membrane
  • Surgical membrane
  • Nasal secretion electric suction device
  • Nasal hemostatic catheter
  • Contact Lens Care Products
  • Temporary filling material

Also, product names and descriptions for additional eighteen medical devices are amended:

  • Sterile pipeline high frequency connection instrument
  • Cardiac Defect Occluder Delivery Device
  • X-ray contrast medium injection device
  • Contrast injection device
  • Carbon dioxide monitor
  • Medical conductive paste
  • Medical molecular sieve oxygen generation system
  • Small molecular sieve oxygen generator
  • Medical Air Oxygen Mixer
  • Medical Air Compressor
  • Metal interlocking intramedullary nail
  • Metal cables and cables
  • Non-absorbable anchor with wire
  • Sternum ligature
  • Analgesic Pump Medicinal Reservoir
  • Infusion information collection system
  • Medical Center Suction System
  • Medical Gas Piping System – Vacuum System

For an English copy of the draft Clinical Trial Exemptions Catalog, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

View our service page on clinical trial exemption

And if you have any further questions about anything related to this list of more clinical trial exemptions, please don’t hesitate to contact us at any time.