The criteria based on Article 42, Paragraph 2 of the PMD Act

    Criteria for vascular prosthesis 
    Criteria for medical adhesive 
    Criteria for medical X-ray system 
    Criteria for ventilator alarm 
    Criteria for vision corrective contact lens 
    Criteria for biological ingredients 
    Criteria for decorative contact lens 
    Criteria for reprocessed single-use medical devices 

The criteria based on Article 41, Paragraph 3 of the PMD Act (Essential Principle)

  【Medical Device】 
    MHLW Notification No.122 of 2005 

  【In-Vitro Diagnostics】 
    MHLW Notification No.126 of 2005 

The Review Points for Software as Medical Devices (SaMD)

    Review Point for Software for Peritoneal Dialysis Treatment 
    Review Point for Supporting Software for Dental Implant Treatment 
    Review Point for Software for Ophthalmic Surgery Treatment Planning 
    Review Point for Supporting Software for Detecting Lesion with Endoscopic Imaging 
    Review Point for Computer-Aided Diagnosis Program to Support Interpretation of Medical Images 

The Review Points for Medical Devices

    Review Points for Biological Safety Evaluation 

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