Revision of insurance coverage and functional classification of insurance medical material

Committee:
Medical Equipment
status:
Progress
Published:
Functional classification exceptions as a means to promot  innovation are continuing. In addition, rapid addition as an effective means for eliminating device lag is continuing, which the EBC views positively. Integrating (rationalisation) of newly classified products in the C application with existing classifications is contrary to the innovation assessment of lowering the price of innovative products and raising the price of products that do not.

Recommendations

  • To ensure transparency and predictability, Japanese authorities should share the specific reasons for the rationalisation study and to secure the time to agree and consultation with the rationalisation proposal.
  • The EBC recommends that newly established functional categories under Category C not be subject to revision for a certain period after their initial designation.