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Guidance by Device Class and Type

Class I devices​

Class I devices follow the Todokede notification pathway. Specific guidance includes:

  • MHLW notification on Class I device notification procedures
  • Prefectural government administrative guidance (varies by prefecture)
  • MO 169 quality requirements for Class I manufacturers (reduced requirements compared to Class II–IV)

Class II devices​

Class II devices may use the Ninsho certification pathway if a recognised standard exists for the device's JMDN code and the device fully complies with that standard. Alternatively, Class II devices without applicable standards, or devices that do not fully comply with designated standards, must follow the Shonin approval pathway. Relevant guidance:

  • MHLW notification on recognised standards list β€” check for your JMDN code
  • RCB-published guidance on certification application requirements (varies by RCB)
  • MHLW notification on conditions for switching from Ninsho to Shonin

Class II device-type-specific guidance:

  • Contact lenses and accessories β€” specific labelling and performance notifications
  • Hearing aids β€” performance standard notifications
  • Diagnostic imaging (X-ray, ultrasound) β€” electrical safety and performance requirements
  • Blood pressure monitors β€” performance standard notifications

Class III devices​

Class III devices primarily use the Shonin pathway via PMDA/MHLW. Relevant PMDA guidance:

  • PMDA consultation guidance for Class III applications
  • PMDA guidance on clinical evidence requirements for specific Class III categories
  • PMDA guidance on re-examination period obligations

Class III device-type-specific guidance:

  • Dialysis equipment β€” specific performance and safety requirements
  • Ventilators and anaesthesia machines β€” electrical safety and performance
  • Orthopaedic implants β€” mechanical testing, biocompatibility, clinical evidence

Class IV devices​

All Class IV devices require Shonin with full PMDA review. Relevant guidance:

  • PMDA guidance on Class IV application data requirements
  • PMDA guidance on QMS inspection for Class IV manufacturing sites
  • PMDA guidance on re-examination period and data collection for Class IV

Class IV device-type-specific guidance:

  • Cardiac stents (drug-eluting and bare-metal) β€” clinical data requirements
  • Pacemakers and ICDs β€” clinical evidence and post-market requirements
  • HIV and blood-screening IVDs β€” performance evaluation requirements

IVDs​

IVD-specific guidance across all classes:

  • PMDA guidance on IVD performance evaluation
  • MHLW notification on IVD reference range data for Japanese population
  • PMDA guidance on IVD clinical performance study design

SaMD / Programme Medical Devices​

  • MHLW notification on classification framework for Programme Medical Devices
  • MHLW/PMDA guidance on AI/ML device regulation
  • PMDA guidance on cybersecurity for software medical devices
  • MHLW notification on SaMD post-market change management (algorithm updates)

"Priority Review and RS Strategy Consultation: Class III devices may be eligible for Priority Review if they address serious unmet medical needs. PMDA's RS Strategy Consultation provides early feedback on review strategy before formal application submission. Contact PMDA consultation services for eligibility assessment."

Expand Class I devices section with: "Conformity assessment: Class I manufacturers must comply with MO 169 QMS requirements, though some low-risk Class I devices may qualify for simplified QMS requirements. Manufacturers should contact their prefectural government for guidance on QMS simplifications applicable to their device type. Some prefectures publish specific Class I quality manuals."

Expand IVDs section to clarify: "IVD pathways: In-vitro diagnostic devices follow the same three-pathway system as other medical devices (Shonin, Ninsho, Todokede) based on JMDN code classification. In-house diagnostics (εŒ»η™‚ζ©Ÿι–’ε†…θ¨Ίζ–­η”¨εŒ»η™‚ζ©Ÿε™¨) may have reduced requirements if the applicant is a clinical facility. Check the JMDN code list and recognised standards list for your IVD to determine applicable pathway."