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Post-Market Clinical Follow-up

When post-market clinical follow-up is required​

Post-market clinical follow-up (PMCF) in the Japan context refers to the collection of clinical data from patients using an approved device in Japan. It is required or expected in the following situations:

  1. As a condition on a Shonin approval — MHLW attaches specific post-market study conditions to approvals for novel or high-risk devices
  2. As part of the GPSP re-examination programme — the use-results survey is Japan's primary PMCF mechanism
  3. When safety signals emerge — new signals identified during routine surveillance may trigger additional focused data collection
  4. For conditional and time-limited approvals — these always have defined post-market evidence requirements (see Conditional and Time-Limited Approval)

PMCF studies in Japan — GPSP vs clinical study​

There are two types of clinical data collection available in the post-market phase:

GPSP use-results survey — the standard mechanism. Observational data collection from routine clinical use. Less rigorous than a clinical study but simpler to conduct and does not require CTN filing.

Post-marketing clinical study — a more structured study design with defined endpoints, control groups, and GCP-like oversight. Required when MHLW determines that observational survey data is insufficient to address specific safety or efficacy questions. Requires a clinical trial notification (or equivalent) and PMDA consultation on the study design.

Integration with re-examination data​

All PMCF data collected during the re-examination period — whether from use-results surveys or formal post-marketing clinical studies — must be included in the re-examination application. The quality and completeness of the PMCF data significantly affects the outcome of the re-examination review.