Audit system adapted to characteristics of program medical equipment

Committee:
Medical Equipment
status:
Progress
Published:
 Collaboration between the industry and the auditing department within the Ministry of Health, Labour and Welfare and PMDA, which have been strengthened. Efforts to identify and resolve issues.

Recommendations

  • Establishment of regulations and examination systems based on characteristics. The EBC requests that a new early approval system is introduced utilising real-world data.
  • SaMD also requested clarification by guidance, etc. on the basic concept for utilizing the two-stage approvals system.