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GPSP — Good Post-market Study Practice

JP-unique

GPSP (Good Post-market Study Practice / 製造販売後調査等の実施の基準に関する省令) is Japan's regulatory framework governing post-market surveillance studies and surveys. It is a Ministerial Ordinance-level requirement — legally binding — and applies to all MAHs holding Shonin approvals. There is no direct equivalent in EU MDR or FDA frameworks, though both have post-market surveillance requirements.

What GPSP requires​

The GPSP Ordinance requires MAHs to:

  1. Establish a post-market surveillance system — formal SOPs, responsible personnel, and a systematic approach to collecting and analysing post-market data
  2. Conduct use-results surveys — systematic collection of clinical outcomes data from healthcare institutions using the device in Japan
  3. Analyse safety and efficacy data — periodic analysis of collected data for safety signals and evidence of real-world efficacy
  4. Prepare and submit periodic reports — regular safety and efficacy reports submitted to MHLW
  5. Conduct re-examination studies — if a re-examination period is attached to the approval, the GPSP studies must provide the data for the re-examination application

Use-results survey (使用成績調査)​

The standard use-results survey (Shiyō Seiseki Chōsa) is the core GPSP activity for most Shonin devices. It involves:

  • Identifying a representative sample of Japanese healthcare institutions using the device
  • Collecting patient-level data on device usage, outcomes, and adverse events
  • Analysing the collected data for safety signals and real-world performance
  • Continuing the survey for the duration of the re-examination period

The survey protocol must be submitted to and accepted by PMDA before survey commencement.

Specified use-results survey (特定使用成績調査)​

A more intensive variant of the use-results survey for specific patient populations or use scenarios — for example, paediatric patients, elderly patients, or use in a specific anatomical location. MHLW/PMDA may specify a requirement for a specified use-results survey as a condition on the approval.

Post-marketing clinical study (製造販売後臨床試験)​

Where standard survey data is insufficient to address specific safety questions, MHLW may require a formal post-marketing clinical study (PMCS) — a structured investigation of the device in clinical use, conducted under GCP-like standards. PMCS commitments are typically conditions attached to the Shonin approval.

MAH obligations under GPSP​

  • Designate a responsible post-market study officer
  • Establish written SOPs for all GPSP activities
  • Maintain records of all surveys and studies
  • Submit periodic reports to MHLW on schedule
  • Submit the final re-examination application before the end of the re-examination period