From April 1st, 2022, Japan’s PMDA will officially start accepting MDSAP reports as a substitution of dossiers for QMS inspection. The benefit of this new regulation is that now foreign manufacturers are principally allowed to omit on-site QMS inspection as well as creation and submission of dossiers that must fulfill local complicated requirements.
In order to use MDSAP to omit Japanese QMS inspections, foreign manufacturers must make sure their MDSAP reports conforms with the Japanese QMS Ordinance (Ord. No.169). In case MDSAP reports miss some of the requirements on the Japanese QMS Ordinance, PMDA will ask to provide supporting documents.
Procedure of Submitting MDSAP Reports