Skip to main content

Device Description and Specification

Required content​

The device description module must enable PMDA to fully understand what the device is, what it does, and how it is used. Required elements include:

Physical description:

  • Complete device name (Japanese and English if applicable)
  • Description of components, sub-assemblies, and materials
  • Dimensions and weight range (for families/sizes)
  • Photographs and diagrams illustrating the device and its components
  • Description of any accessories or ancillary equipment

Functional description:

  • Operating principle — how the device achieves its intended effect
  • Intended use statement (Japanese language) — this will become the approved indication on the Shonin
  • Contraindications
  • User population and use setting (hospital, clinic, home use)

Technical specifications:

  • Performance characteristics with acceptance criteria
  • Output parameters (for active devices)
  • Software version identification (for devices with software)

Intended use and intended purpose — Japan's framing​

PMDA is precise about the intended use statement. The approved intended use (劚čƒŊ劚果 for drugs; äŊŋį”¨į›Žįš„ for devices) is what appears on the Shonin and what the MAH is legally permitted to claim. Anything not in the approved intended use is an off-label claim under Japanese law.

The intended use must be drafted carefully before submission because changes after approval require Ichibu Henko (partial change approval).

Device families and variants​

If the application covers multiple sizes, configurations, or models:

  • Clearly identify all variants included in the application
  • Demonstrate that the worst-case variant(s) were tested in the performance and safety studies
  • Provide a family rationale showing why all variants can be covered by the same application

JMDN code documentation​

The application must include justification for the JMDN code assigned to the device. This includes:

  • Statement of the JMDN code and the device type name it covers
  • Explanation of why the device falls within this JMDN category
  • Confirmation of the resulting risk class