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Risk Management (ISO 14971)

ISO 14971 in the Japanese context​

ISO 14971 (Application of risk management to medical devices) is a recognised standard in Japan. PMDA expects applicants to conduct and document risk management in accordance with ISO 14971. The QMS Ordinance (MO 169) also incorporates risk management requirements that align with ISO 14971.

Japan adopted ISO 14971:2019 as the current recognised standard. Previous versions (ISO 14971:2007 with EN modifications) were used for applications submitted before the transition deadline.

How risk management integrates with Essential Principles​

Japan's Essential Principles (基本要仢) β€” the equivalent of EU GSPR β€” require device designers to identify and mitigate known and foreseeable hazards. The Essential Principles checklist in the application dossier must cross-reference the risk management file to demonstrate that hazards have been identified and that residual risks are acceptable.

The risk management summary in the application dossier should:

  1. Confirm that a complete risk management process per ISO 14971 was performed
  2. Identify the key hazards identified for the device
  3. State the risk control measures implemented
  4. Confirm that the overall residual risk is acceptable when weighed against the clinical benefits
  5. Reference the risk management file (held by the MAH/manufacturer, not submitted in full)

PMDA expectations for risk management documentation​

PMDA does not review the complete risk management file in detail during the application review (the file is reviewed during QMS inspection rather than application review). However, the risk management summary in the application must be sufficient to allow PMDA to understand:

  • That a systematic process was followed
  • That all reasonably foreseeable hazards were considered
  • That the risk/benefit profile is acceptable for the intended use

PMDA reviewers may query specific risk items if the summary is unclear or if a known hazard for the device type is not addressed.