ACHIEVEMENTS
REGULATORY
| Company | Class | Submission Classification | Clinical trial | Note |
|---|---|---|---|---|
| Company A (US) | 4 | new medical device | YES | Had supported from regulatory submission preparation and got regulatory approval within standard period. Work continuously as regulatory consultant for approval maintenance, regulatory issue and review marketing material and support all issue related to Japanese market raised by the client. *ongoing |
| 3 | improved w/o clinical | NO | ||
| 3 | improved w/o clinical | NO | ||
| Company B (US) | 4 | planned as improved w/clinical | YES | Evaluated regulatory pathway and reimbursement pathway. Worked with client for preparation of regulatory submission in Japan. * Suspended due to client internal priority change. |
| Company C (US) | 4 | new medical device | YES | It was continuously supported by my previous company due to customer request. This was successful in obtaining approval as a new medical device, even though the PMDA, as a result of the consultation meeting, thought it was an "improved medical device". |
| 3 | new medical device | NA |
REIMBURSEMENT
| Company | Type | Calculation Method | Technical Fee |
STM (Device Fee) |
Note |
|---|---|---|---|---|---|
| Company A (US) | C2 | cost accouting | YES | YES | Worked with strategic consultant. |
| C2 | similar functional category | YES | YES | ||
| C2 | similar functional category | NA | YES | ||
| Company C (US) | C2 | cost accouting | YES | YES | Worked with strategic consultant. |
| C2 | NA | YES | NA | ||
| Company D (US) | C2 | similar functional category | YES | NA | Worked with strategic consultant. |
| Company E (US) | C2 | cost accouting | YES | YES | Worked with strategic consultant. |
| Company F (US) | C2 | similar functional category | YES | YES | Worked with strategic consultant. |