CMDE release 4 guidance for medical device product registration review

On February 5, 2024, China CMDE released 4 guidance documents for ME Equipment submission and review as the following:

  1. Guideline for Positron Emission Magnetic Resonance Imaging Systems
  2. Guideline for Single Photon Emission X-ray Computed Tomography Systems
  3. Guideline for Ventilator (2023 Revised Edition)
  4. Guideline for Nitric Oxide Therapy Device

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