Abstract
The fourth year of revised Pharmaceutical Affairs Law enforcement
We appreciate you applicants very much. We have implemented the certification practive over 700 items and more than about 200 cases per year.
Certification practice division was limited to an item to become an application of JIST0601-1 at first of a revision to the act, nonetheless, number of cases have been thankfully increased steadily. On the other hand, we had a lot of inquiries about the other items (non-active medical equipment) from many applicants from the beginning and are sorry for the inconvenience, however we measured up to enlarge the sphere of business about the other division in January, 2007 and can involve in all specific controlled medical equipment certification practices.
I gather up demands and expectations from Marketing Approval Holders as the applicant to our certification organization which I felt through these certification practices and my idea for the roles that we should carry out as the certification organization and report them.
