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Marketing Authorization of Medical Devices in Japan

Determining Registration Route

  • JMDN Codes primarily determine registration routes

    • Class I Class II Class III Class IV
    Pre-Market Submission
    ("Todokede")    		 ✓
    Pre-Market Certification
    ("Ninsho")    		 ✓ ✓
    Pre-Market Approval
    ("Shonin")    		 ✓ ✓ ✓ ✓
    • Most of Class II and some Class III medical devices are considered "Specified Controlled" devices" and "Specified Highly Controlled" devices which are subject to third party review system for Pre-market Certification registration route.
    • New medical devices (no JMDN) are required PMA regardless of classification

    Pre-market Approval (PMA)

  • MAH will submit a pre-market approval application to the PMDA and ultimately obtain approval from the MHLW

      Class I and II devices without JMDN code are subject to PΜΑ

      Class II and III devices without a Certification Standard are subject to PMA

      Class IV devices require PMA

      QMS Conformity Assessment could be either on-or-offsite, depending on the device and / or condition of the Certificate of QMS Conformance

    • PMA Appleication Modules

    Application module Applicability Remark
    Generic or me too
    ("Kohatsu-tryoukiki")
    		 Existing JMDN code with submission based on a registered technical file Difficult for companies to prove to completely device unless a side by side comparison is made; generally good for when company is upgrading a device
    Improved
    ("Kaizen-ryoukiki")
    		 Existing JMDN code with submission based on new technical file including comparison table Doesn't necessarily mean clinical data is required; may be able to support safety & efficacy with verification & validation testing
    New
    ("Shin-tryoukiki")
    		 No existing applicable JMDN code Require clinical data

    PMA Application Modules - Cont'd

  • Applied PMA application module is varied and determined from various application types

    • Application module
    Class IV: Generic device (with approval standard, without clinical data)
    Class IV: Generic device (without approval standard or clinical data)
    Class II or III: Generic device (with approval standard, without clinical data)
    Class IV: Improved device (with clinical data)
    Class IV: Generic device (with approval standard, without clinical data)
    Class II or III: Improved device (with clinical data)
    Class II or III: Improved device and Generic device (without approval standard or clinical data)
    Class IV: New device
    Class II or III: Generic device

    Reliability Conformity Assessment for non-clinical data

  • According to the Standard of Reliability of Application Data of the MHLW, applicant of Pre-market Approval/Certification must ensure reliability of all data used for submission.

  • PMDA conduct the document-based conformity assessment for non-clinical data to review reliability of the data use.

  • Provide supported documents/records (e.g., source data, protocol, SOP of non-clinical tests) during review of a submission

  • Micren provides the Self-Conformity Assessment Checklist

    • Foreign Special Approval System

  • Generally Japan domestic MAH can be an applicant and a holder of PMA/PMC

  • The Foreign Special Approval System (FSAS) allows foreign manufacturers to be an applicant and a holder of PMA/PMC

      Foreign manufacturer is a quasi-МАН

      FSAS does not apply to Class 1 device or PMS

  • To adopt FSAS, foreign manufacturer select a designated marketing authorization holder or "DMAH"

  • DMAH must handle release judgment, vigilance activity, safety reporting, recall reporting

  • Before release judgment by DMAH, imported medical device must ship to and store at the registered warehousing manufacturer of final product in Japan
    ("Kokunai Saishu Seihin Hokan Seizosyo")

  • DMAH's responsibility is increasing, e.g., data reliability, change control etc.