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Ministerial Ordinance on Clinical Trial Standards (GCP for Devices)

Applicable ordinance​

The Good Clinical Practice standards for medical device clinical trials in Japan are established in:

  • Ministerial Ordinance on Standards for Clinical Trials of Medical Devices (医療機器の臨床試験の実施の基準に関する省令)
  • Often referred to as GCP Ordinance for Devices or Device GCP

This is separate from the GCP Ordinance for pharmaceuticals — device clinical trials are governed by device-specific GCP requirements.

Official source

e-Gov — Device GCP Ordinance (search 医療機器 臨床試験 基準)

GCP requirements for device clinical trials in Japan​

Sponsor responsibilities: File a Clinical Trial Notification (CTN) with MHLW at least 30 days before first subject enrolment; this is a notification (not pre-approval) requirement Ensure the trial is conducted in accordance with the protocol approved by the Ethics Committee Monitor the trial at all participating institutions and maintain oversight of compliance Report serious adverse events to MHLW and the sponsoring institution's Ethics Committee according to specified timelines Conduct periodic audits of trial conduct and maintain a complete trial master file with all regulatory documentation

Investigator responsibilities:

  • Obtain and document informed consent from each subject
  • Conduct the trial in accordance with the protocol
  • Report adverse events to the sponsor promptly
  • Maintain investigator site file records

Ethics committee requirements:

  • Each participating institution must have the trial approved by an MHLW-accredited Ethics Committee (倫理審査委員会)
  • Approval must be obtained before any subject is enrolled at that site
  • Amendments to the protocol must be reviewed by the Ethics Committee before implementation

Written informed consent must be obtained from each subject before any trial procedure. The consent process and form must comply with specific content requirements in the GCP Ordinance. If a subject cannot consent personally (e.g. in an emergency), specific alternative consent provisions apply.

CTN filing process​

See Clinical Trials under the PMD Act for the CTN filing process and practical guidance.

Serious adverse events must be reported to MHLW within 7 days of becoming aware of the event, or according to the timeframe specified in the CTN approval notification. Expedited reporting may be required for fatal or life-threatening events.