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NMPA: Fifty-four Draft Registration Review Guidelines Issued in One Day

  • 1.  NMPA: Fifty-four Draft Registration Review Guidelines Issued in One Day

    Posted 20-Dec-2023 15:53
    Edited by Grace Fu 20-Dec-2023 15:55

    NMPA published 54 draft Registration Review Guidelines on October 25, 2023 for feedback. 

    Significance of Device Registration Review Guidelines 

    In general, the parallel guidelines will be released right after the standards. If it is the first registration of your product, the manufacturer needs to comply with the latest guidelines.   

     

    If your product is undergoing changes, upgrades, or renewal and is related to the latest guideline mentioned above, please assess whether an upgrade testing is required to comply with the latest requirements of NMPA.  

    Full List of Guidelines

    ·         Registration Review Guideline on Electric Photography Flat Bed

    ·         Registration Review Guideline on Medical Gas Alarm System

    ·         Registration Review Guideline on Air Oxygen Mixer

    ·         Registration Review Guideline on Laser Positioning System

    ·         Registration Review Guideline on In Vivo Electrodes for Nerve and Muscle Stimulators

    ·         Registration Review Guideline on Traditional Chinese Medicine Pulse Diagnosis Equipment

    ·         Registration Review Guideline on Rehabilitation Training Bed

    ·         Registration Review Guideline on Medical Gynecological Gel

    ·         Registration Review Guideline on Disposable Oxygen Mask

    ·         Registration Review Guideline on Nebulizer Mask

    ·         Registration Review Guideline on Bronchial Blocker

    ·         Registration Review Guideline on Medical Catheter Fixation Device

    ·         Registration Review Guideline on Respiratory Mask

    ·         Registration Review Guideline on Micromanipulation Tubes for Assisted Reproduction

    ·         Registration Review Guideline on Medical Sodium Hyaluronate Wound Dressing

    ·         Registration Review Guideline on Electrolyte Analyzer

    ·         Registration Review Guideline on Glucose Detection Reagent

    ·         Registration Review Guideline on Gram-Negative Bacilli Identification Reagent

    ·         Registration Review Guideline on Pyruvate Detection Reagent

    ·         Registration Review Guideline on Α-Amylase Detection Reagent

    ·         Registration Review Guideline on Alpha-Hydroxybutyrate Dehydrogenase Detection Reagent

    ·         Registration Review Guideline on Magnesium Detection Reagent

    ·         Registration Review Guideline on Semi-Automatic Chemiluminescent Immunoanalyzer

    ·         Registration Review Guideline on Dental Comprehensive Treatment Machine

    ·         Registration Review Guideline on Hearing Aid

    ·         Registration Review Guideline on X-Ray Diagnostic Equipment (Class II)

    ·         Registration Review Guideline on Medical Nebulizer

    ·         Registration Review Guideline on Creatine Kinase Detection Reagent

    ·         Registration Review Guideline on Positive Pressure Ventilation Therapy

    ·         Registration Review Guideline on Magnetic Therapy Products

    ·         Registration Review Guideline on Coagulation Analyzer

    ·         Registration Review Guideline on Medical Endoscope Cold Light Source

    ·         Registration Review Guideline on Sialic Acid Detection Kit (Enzymatic Method)

    ·         Registration Review Guideline on Β2-Microglobulin Detection Reagent

    ·         Registration Review Guideline on Lactate Dehydrogenase Assay Kit

    ·         Registration Review Guideline on Thyroid Stimulating Hormone Detection Reagent

    ·         Registration Review Guideline on Ischemia Modified Albumin Assay Kit

    ·         Registration Review Guideline on Glycated Hemoglobin Determination Kit (Enzymatic Method)

    ·         Registration Review Guideline on Vibration Percussion Expectoration Machine

    ·         Registration Review Guideline on Urine Analyzer

    ·         Registration Review Guideline on Peritoneal Dialysis Equipment

    ·         Registration Review Guideline on C-Reactive Protein Assay Kit

    ·         Registration Review Guideline on Medical Image Storage and Transmission System Software (Pacs)

    ·         Registration Review Guideline on Urine Formed Component Analyzer

    ·         Registration Review Guideline on Large Steam Sterilization

    ·         Registration Review Guideline on Alkaline Phosphatase Detection Reagent

    ·         Registration Review Guideline on Hemodialysis Water Making Equipment

    ·         Registration Review Guideline on Triglyceride Detection Reagent

    ·         Registration Review Guideline on Blood Glucose Meter

    ·         Registration Review Guideline on Human Chorionic Gonadotropin Detection Reagent (Colloidal Gold Immunochromatography)

    ·         Registration Review Guideline on Albumin Determination Reagent (Box)

    ·         Registration Review Guideline on Fecal Occult Blood (Fob) Detection Kit (Colloidal Gold Immunochromatography)

    ·         Registration Review Guideline on Electronic Blood Pressure Monitor (Oscillometric Method)

    ·         Registration Review Guideline on Biomedical Analyzer

    Regarding the above guidelines, if you have any questions, please email me.



    ------------------------------
    Grace Fu
    China Med Device, LLC
    gpalma@ChinaMedDevice.com
    Phone US: (978) 390-4453
    Phone China: 18201749732
    www.ChinaMedDevice.com
    ------------------------------



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