Audit system adapted to characteristics of program medical equipment

Committee:
Medical Equipment
status:
Progress
Published:
 Collaboration between the reinforced review departments within the Ministry of Health, Labour and Welfare (MHLW) and the PMDA, and the industry — efforts aimed at identifying and resolving issues.

Recommendations

  • Establishment of regulations and examination systems should be based on characteristics. The EBC requests that a new early approval system is introduced utilising real-world data.
  • The EBC recommends that the basic concept for applying the two-step approval system to Software as a Medical Device (SaMD) be clearly outlined through official guidance or other means.