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Japan QMS Overviews

  • MAH must implement Quality Management System in compliance with MHLW Ministry Ordinance No.169

  • MAH must maintain the organization of MAH responsibilities under QMS requirements for licensing in compliance with MHLW Ministry Ordinance No. 94 ("Taisei Syorei" or QMS Structure Regulation)

      e.g., assignment of qualified general manager (Sokatsu Seizo Hanbai Sekininsya), quality control responsible manager (Kokunai Hinshitsugyomu Uneki Sekininsya) and management representative (Kanrisekininsya) roles.

  • MAH must implement Good Vigilance System in compliance with MHLW Ministry Ordinance No.135

    • Image of Relationship with related standards and regulations

    ISO13485 Quality Management System

    QMS Structure Regulation ("Taisei Shorei")

    Chapter 2 of QMS Regulation
    Chapter 3 of QMS Regulation
    GVP Regulation

    Pharmaceuticals and Medical Devices Act (Also known PMD Act)

    Chapter 1
    General Provisions (Article 1 to Article 3)
    Chapter 2
    Basic Requirements Regarding Manufacturing Control and Quality Control of Medical Devices, etc.
    Section 1 General Requirements (Article 4)
    Section 2 Quality Management System (Article 5 to Article 9)
    Section 3 Management responsibility (Article 10 to Article 20)
    Section 4 Resource Management (Article 21 to Article 25)
    Section 5 Product Realization (Article 26 to Article 53)
    Section 6 Measurement, Analysis and Improvement (Article 54 to Article 64)
    Chapter 3
    Additional Requirements Regarding Manufacturing Control and Quality Control of Medical Devices, etc. (Article 65 to Article 72-3)
    Chapter 4
    Manufacturing Control and Quality Control of Biological Medical Devices, etc. (Article 73 to Article 79)
    Chapter 5
    Manufacturing Control and Quality Control of Radioactive In Vitro Diagnostic Reagents (Article 80 and Article 81)
    Chapter 6
    Application mutatis mutandis, etc. to Manufacturers, etc. of Medical Devices, etc. (Article 82 to Article 84)

    Key Differences

    Retention times for obsolete documents and records

    "Obsolete" documents, and records to be retained;

    • 5 years for training records and documentation
    • 15 years for 'specially designated maintenance-controlled-required' devices
    • 5 years or shelf life + 1 year other than 'specially designated maintenance-controlled-required' devices
    "SeihinHyojunSho"

    Equivalent to the medical device file required by ISO13485 section 4.2.3 and must be prepared for each device family

    MAH related requirements

    Chapter 3 mainly defines additional requirements, e.g., Domestic Quality Control Responsible Manager ("Kokunai Hinshitsugyomu Unei Sekininsya"), Designated Marketing Authorization Holder requirements etc.

    QMS Conformity Assessment

  • Applicant of PMA/PMC must take QMS Conformity Assessment

  • QMS Conformity Assessment application; e.g., documents such as QM, ISO 13485 certificate (if available), product list, manufacturing flow chart, floor plan, etc.

  • On-site audit is sometime required in case, e.g., new device etc.

  • Application to be made within 10 days after submission of PMA application

  • Certificate of QMS Conformance ("Kijun Tekigo Sho") will be issued

  • A certificate is valid for 5 years

  • The manufacturing sites (Establishment) listed on the certificates of QMS Conformance are exempt from future conformity assessments when devices from the same product group ("Seihingun") on those certificates are registered with the PMDA or RCB