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These Devices Exempted for Clinical Trial: Faster Market Access for Laboratory, Dental, Sterilization Companies

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The NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on May 19, 2022. The document suggests manufacturers how to choose clinical evaluation exemption, predicate device comparison or clinical trial. 126 medical devices in the fields of laboratory, dental, sterilization, infusion, protection, and patient carrying are affected.

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

Clinical Evaluation Exemption List

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

Laboratory

  • Blood cell analyzer
  • Coagulation analyzer
  • Platelet analyzer
  • Blood flow analysis instrument
  • Flow Cytometry Instruments
  • Biochemical analysis instrument
  • Blood sugar and blood sugar related parameter analyzer
  • Electrolyte Analysis Instrument
  • blood gas analyzer
  • Electrolyte blood gas analyzer
  • ELISA instrument
  • Chemiluminescence immunoassay instrument
  • Fluorescence immunoassay instrument

Dental

  • cement
  • glue
  • root canal filling material
  • silver amalgam
  • pulp capping material
  • Metal Materials for Additive Manufacturing
  • Metal materials and products
  • polymer materials and products
  • custom denture
  • Periodontal pocket detection device
  • Implant Equipment
  • curing equipment
  • root canal treatment equipment
  • Bone meal preparation equipment

Sterilization

  • steam sterilizer
  • Boiling Sterilizer
  • pressure steam sterilizer
  • hot air sterilizer
  • hot air sterilizer
  • Thermal radiation sterilizer
  • Acid Oxidation Potential Water Generator
  • ozone sterilizer
  • Ethylene oxide sterilizer
  • Formaldehyde Sterilizer
  • Hydrogen Peroxide Sterilizer
  • UV Sterilizer

Also listed are infusion, protection and patient carrying equipment.

Visit 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.

Laboratory

  • LabCorp
  • Sanofi Genzyme
  • Quest Diagnostics
  • Abbott Laboratories
  • Charles River Laboratories, Inc.
  • Bio-Reference Laboratories
  • Spectra Laboratories
  • Genoptix Medical Laboratory
  • ARUP Laboratories
  • Clarient, Inc.

Dental

  • Henry Schein
  • Dentsply Sirona
  • Patterson
  • Danaher

Sterilization

  • Steris
  • 3M
  • Getinge
  • MMM
  • Belimed
  • Matachana
  • Sotera Health
  • Cardinal Health