Lease business of medical equipment was changed to loan business by "law to revise a part of the Pharmaceutical Affairs Law" having been enforced on November 25, 2014. In this way, we become a target of permission or Notifecations as "loan business" when we lend altitude management medical equipment or managed care apparatus without company continuing repeatedly, and getting value.
In addition, please be careful in various Applications and notifications as necessary documents are revised in the permission application.
About risk classification and necessary procedure for medical equipment
When we sell medical equipment and confer or lend or we display for the purpose of these, procedure that accepted class classification of medical equipment to handle is necessary.
- "It is procedure-free" without corresponding to "specific maintenance managed care apparatus" when only medical equipment classified in "one kind" by class classification is handled
- "We report" without corresponding to "specific maintenance managed care apparatus" when medical equipment classified in "two kinds" by class classification is handled
- When medical equipment classified in "three kinds or four kinds" by class classification is handled; "permission"
- It becomes "permission" regardless of class classification in any of "the specific maintenance managed care apparatus".
Apparatus of the handling, please confirm to supplier and maker about necessary thing of permission or necessary thing of Notifecations or thing which is procedure-free on sale.
We perform the Notifecations acceptance of person corresponding to permission application reception desk and "Notifecations" corresponding to "permission" in the prefectural office Pharmaceutical Division.
About class for qualification
On permission or Notifecations, qualification of medical equipment (instrumentarium) sale and loan manager is necessary.
Guidance of class to acquire qualifications is published in homepage of Japan home health apparatus industry society, medical equipment center and synthesis health promotion foundation.
Please advance from related link to each homepage.
In addition, class may be attended in what site.
In addition, we do not need setting of manager only in Notifecations of dealership, loan business when we handle home "alkali ion *suiki" "magnetism treatment device" "vibrator" without handling "management medical equipment for medical institutions" "hearing aid" "home electric therapy device" even if we handle managed care apparatus for Notifecations. (April 1, 2006 revision)