Japan Medical Device Post-Market Surveillance (PMS)

Post-Market Surveillance (PMS) for medical devices in Japan is mandatory and heavily regulated by the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW), as stipulated in the Pharmaceutical and Medical Device Act (PMD Act).

🔑 Key Responsibilities and Compliance

The Marketing Authorization Holder (MAH) is legally responsible for all PMS activities, ensuring the continuous safety and efficacy of the device once on the market.

• Good Vigilance Practice (GVP): The MAH must establish and maintain a PMS system compliant with MHLW's Good Vigilance Practice (GVP) Ordinance. GVP outlines standards for the organization, collection, assessment, and implementation of safety measures.
• Safety Actions: Based on PMS data, the PMDA may require the MAH to implement safety measures, including:
  • Product recalls and repairs.
  • Revisions to the 'tempu bunsho' (package inserts/IFUs).
  • Dissemination of safety information to healthcare professionals (e.g., PMDA Alerts).

🚨 Adverse Event (AE) Reporting (Fuguai)

The MAH must record and report all safety issues, commonly referred to as Fuguai (adverse events or malfunctions), via the PMDA's electronic Adverse Event Reporting System.

Reportable Events: Adverse events include device breakage/failure, malfunction, defective products, adverse health effects, and deficiencies in the provided IFU/labeling. Reports must also be submitted for adverse events occurring with Japanese-approved devices in other countries.

📝 Post-Marketing Studies and Re-evaluation

For certain high-risk or new devices, the PMDA may mandate post-marketing studies to gather real-world evidence of safety and performance. Additionally, the system includes a Re-examination and Re-evaluation process to comprehensively review approval conditions and clinical data after a set period (typically 4-10 years for drugs, though applicable concepts exist for devices).