Evaluation of medical devices and SaMD bundled into technical fees

Committee:
Medical Equipment
status:
Progress
Published:
Progress was made toward improving predictability in the evaluation of SaMD bundled into technical fees and of new functions and new technologies submitted through C2 applications. However, there was no progress on the request to include technical fee reduction effects in the cost-effectiveness premium for specified insured medical materials.

Recommendations

  • Specify the evaluation perspectives, required evidence and methods for calculating evaluation amounts, ensuring the predictability companies need to make decisions on development and introduction in Japan.
  • Appropriately evaluate patient benefit, quality of care, cost-effectiveness and the costs required to provide new technologies.
  • Expand the cost-effectiveness premium for specified insured medical materials to cover not only material costs but also reductions in technical fees, such as testing fees.
  • Ensure consistency between the evaluation of devices bundled into technical fees and that of specified insured medical materials.