QMS mutual recognition and global standards

Committee:
Medical Equipment
status:
Some progress
Published:
Some progress was shown in conformity with the global standards. Formal participation in the MDSAP (Medical Device Single Audit Program) assists further development of discussions for conformity with the global standards.

Recommendations

  • Japan shall eliminate the differences in requirements of the QMS ministerial ordinance, and conform with the global standards for the product group classification.