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Clinical Trials under the PMD Act

When clinical trials are required​

Not all Shonin applications require Japan-specific clinical trial data. The need for clinical trial evidence depends on:

  • Device class and novelty — novel Class III/IV devices almost always require clinical data; well-established device types with accepted foreign data may not require new Japanese trials
  • Availability of acceptable foreign data — PMDA may accept foreign clinical study data, reducing the need for new Japanese trials
  • PMDA's requirements as communicated in pre-submission consultation — the most reliable way to determine data requirements is to ask PMDA directly

Where Japan-specific clinical evidence is required, clinical investigations must comply with the PMD Act's clinical trial requirements.

Clinical Trial Notification (CTN) — the filing process​

Before commencing a clinical investigation of a medical device in Japan, the Clinical Trial Notification (CTN) (治験届 — chiken todoke) must be filed with MHLW. This is a mandatory notification, not a MHLW approval or authorisation.

CTN filing requirements:

  1. Prepare the CTN dossier (investigational device description, clinical trial protocol, investigator information, ethics committee documentation)
  2. Submit the CTN to MHLW at least 30 days before the planned first patient enrolment (the 30-day notification period allows MHLW to request modifications)
  3. Obtain ethics committee approval from the institution's ethics committee
  4. Obtain PMDA opinion on the investigational plan (through a pre-trial consultation, strongly recommended for pivotal trials)

GCP for devices — applicable ordinance​

Clinical investigations of medical devices in Japan must comply with the Ministerial Ordinance on Standards for Clinical Trials of Medical Devices (GCP Ordinance for devices). This is separate from the GCP Ordinance for drugs and has device-specific provisions.

Key GCP requirements include:

  • Written informed consent from each subject
  • Ethics committee review and approval
  • Investigational device accountability
  • Adverse event reporting during the trial
  • Monitoring and audit by the trial sponsor (typically the MAH)
  • Protocol amendments filed with MHLW before implementation

PMDA consultation before trial commencement​

For any clinical investigation that is intended to support a Shonin application, PMDA pre-trial consultation is strongly recommended (and for novel devices, effectively required). PMDA will advise on:

  • Whether a Japan-specific trial is needed
  • Acceptable study design (endpoints, control group, sample size)
  • Whether foreign study data can bridge or supplement Japanese data
  • Timing and format of interim data sharing with PMDA