Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices

    Japan's classification system differs from that of the United States or European Union
    Medical devices are classified to Class I, II, III, or IV depending on their risk level
    Medical devices must also comply with Japanese Industrial Standards and these standards define industry-wide safety and performance requirements
    Strict new package insert requirements
    Change to MAH Licensing rules
    A new MAH License category for In Vitro Diagnostic (IVD) devices
    A new registration system for manufacturers
    A new QMS conformity assessment system
    New formats for pre-market certification and pre-market approval applications
    Expanded scope of third party certifications
    Rules for software as a medical device
    Rules for transferring pre-market certifications
    And Much More...