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Essential Principles Checklist

JP-unique

Japan's Essential Principles (基本要件 — kihon yōken) are specified in Ministerial Ordinance and serve a similar function to the EU MDR's General Safety and Performance Requirements (GSPR). A completed Essential Principles checklist is a mandatory component of every Shonin (approval) application.

What the Essential Principles require​

The Essential Principles set out the fundamental safety and performance requirements that every medical device must meet before it can be approved in Japan. They are structured around broad categories:

  1. Safety — the device must not compromise patient safety; risks must be reduced to acceptable levels using recognised engineering practices
  2. Performance — the device must perform as intended under normal use conditions
  3. Design and construction — physical and chemical properties must be safe; devices must resist environmental degradation
  4. Interactions with the environment — EMC, software reliability, infection control
  5. Labelling — labels and IFU must provide all information needed for safe use
  6. Clinical evaluation — evidence of safety and efficacy in the intended use population

The full list of Essential Principles is published by MHLW in the relevant Ministerial Ordinance.

Structure of the checklist​

The checklist lists each Essential Principle (by number and description) and requires the applicant to:

  1. Confirm whether the principle is applicable to the device (with justification for non-applicable items)
  2. For each applicable principle, cite the method(s) used to demonstrate compliance — typically a reference to a recognised standard, test report, or design documentation
  3. Reference the supporting data in the application dossier

The checklist format is prescribed by MHLW/PMDA and must be completed in Japanese.

Linking standards to Essential Principles​

The most common way to demonstrate compliance with an Essential Principle is to reference a recognised standard that addresses the principle. For example:

  • Essential Principle on electrical safety → IEC 60601-1
  • Essential Principle on biocompatibility → ISO 10993 series
  • Essential Principle on software safety → IEC 62304
  • Essential Principle on sterilisation → applicable ISO sterilisation standard

Where no standard fully covers a principle, the applicant must explain the alternative method (testing, analysis, or design review) used to demonstrate compliance.

Gaps in standards coverage​

Not every aspect of every device is covered by a recognised standard. For gaps:

  • Describe the test method or engineering analysis used
  • Provide the acceptance criteria and the result
  • Reference the test report in the dossier

PMDA will question Essential Principles entries that are vague or unsupported. Incomplete checklist entries are one of the most common causes of PMDA queries during application review.