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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 typically use the Ninsho certification pathway if covered by a recognised standard. Relevant guidance:

  • MHLW notification on recognised standards list — 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 — specific labelling and performance notifications
  • Hearing aids — performance standard notifications
  • Diagnostic imaging (X-ray, ultrasound) — electrical safety and performance requirements
  • Blood pressure monitors — 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 — specific performance and safety requirements
  • Ventilators and anaesthesia machines — electrical safety and performance
  • Orthopaedic implants — 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) — clinical data requirements
  • Pacemakers and ICDs — clinical evidence and post-market requirements
  • HIV and blood-screening IVDs — 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)