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NMPA: 49 Class III Devices Impacted by 2024 Guidelines Revisions Plan

NMPA published the “2024 Medical Device Guidelines Revisions Plan” today on April 11, 2024, in which 49 guidelines for Class III and 60 for Class II devices are affected. The revisions are aimed to facilitate manufacturers with more guidance and clarity in registration process.

Significance of NMPA Guidelines

The guidelines are introduced by NMPA Center of Medical Device Evaluation (CMDE). It is not legally binding but highly recommended by regulatory authorities. The revision plan will not only impact the new product registration but also renewals and modifications. It involves type testing, clinical, registration review guidelines, technical guidelines, e.g., Real World Study design, and documentation guidelines, e.g., Indication for Use (IFU) writing. 

NMPA issues new or updated guidelines throughout the year. Given their importance in understanding what the NMPA reviewers are looking for, it is essential that manufacturers keep up to date with the guidelines that are latest to their specific products. One source to get updates on these guidelines is through our complimentary monthly news roundup that you can opt in from our website www.ChinaMedDevice.com

The List

The plan involves newly-established and revised guidelines. It includes but is not limited to the following. For the full list please contact info@ChinaMedDevice.com

Class III Devices

  • Magnetic Resonance Imaging system safety assessment
  • Contrast medium high-pressure injection equipment
  • X-ray blood irradiation equipment
  • Portable electric infusion pump
  • Extracorporeal membrane oxygenation equipment animal testing
  • Radiation treatment planning software
  • Ray beam scanning measurement system
  • Laparoscopic surgical systems part 3: systems and software
  • Fluorescence diagnostic capabilities of active optical devices
  • Carbon dioxide laser treatment machine
  • Tumor radiofrequency ablation equipment
  • Electrocoagulation cutting endoscope
  • Capsule endoscope system
  • Urinary system laser treatment machine
  • Laparoscopic surgical systems part 4: risk management
  • Aortic stent graft
  • Acellular matrix soft tissue wound repair materials
  • Transcatheter valve clamp system
  • Memory alloy rib plate
  • Metal bone needle
  • … …

Class II Devices

  • Home non-invasive ventilator (non-life support)
  • Medical center suction system
  • traction bed
  • visual training device
  • gastroscopy lubricant
  • scissors for endoscopic surgery
  • Gastrointestinal contrast imaging agent
  • Orthotics
  • Disposable rhinoscope
  • Nasal ventilation patch
  • Disposable endoscopic biopsy bag
  • Disposable sterile urethral dilator
  • Medical radiation protection spray
  • Trace element analyzer
  • Streptococcus identification reagent
  • Lipoprotein a detection reagent
  • Blood rheology analyzer
  • γ-Glutamyl transferase detection reagent
  • Anti-thyroglobulin (TG) antibody detection reagent
  • … …