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Class II — Controlled Medical Devices

Class II devices (管理医療機器) are moderate-risk devices. They represent the most numerically common category of devices seeking market access in Japan, and most use the Ninsho (certification) pathway.

Characteristics​

Class II devices are typically:

  • Moderate risk with defined failure modes
  • Contact body surfaces or body cavities without penetrating tissue
  • Non-implantable, or if implantable, low contact duration
  • Covered by MHLW-designated recognised standards in most cases

Examples of Class II devices​

Hearing aids, contact lenses, diagnostic ultrasound equipment, dental crowns and bridges, X-ray film, non-implantable orthopaedic supports, blood pressure monitors (consumer-grade), certain IVDs.

Regulatory pathway — Ninsho (usually)​

The Ninsho (certification) pathway is available for Class II devices that fall within the scope of an applicable MHLW-recognised standard. This covers the large majority of Class II devices.

If no applicable recognised standard exists for the specific device type, the MAH must use the Shonin (approval) pathway even for a Class II device. This is less common but does occur for novel Class II devices.

When Shonin is required for Class II​

A Class II device requires Shonin when:

  1. No MHLW-recognised standard exists for the device type
  2. The device has features that take it outside the scope of the otherwise applicable standard
  3. MHLW has specifically designated the device type as requiring Shonin

If you begin a Ninsho application and the RCB determines the device falls outside the standard, you will need to restart with a Shonin application.