光學(xué)鏡架fda注冊
1、2017年醫(yī)療器械企業(yè)的FDA年費為3382美金。
這也是近三年來FDA年費首次降價。如下所示。
Application Type | Standard | Small Bussiness |
Premarket Application (PMA,BLA,PSP) | 234,495 | 58,624 |
Premarket Report(PMR) | 234,495 | 58,624 |
Panel-Track PMA supplement | 175,871 | 43,968 |
BLA Efficacy Supplement | 234,495 | 58,624 |
180-Day PMA Supplement | 35,174 | 8,794 |
Real-Time PMA Supplement | 16,415 | 4,104 |
Premarket Notification (510(K)) | 4,690 | 2,345 |
30-day notice | 3,752 | 1,876 |
513(g)request for classification information | 3,166 | 1,158 |
Annual fee for periodic reporting on a class III device | 8,207 | 2,052 |
Establishment Registration Fee-There is no reduced fee for a small business. If this is the only fee you expect to pay during FY 2017,doyou submit an FY 2017 Small Businesss Qualification and Certification request. | ||
Type of Fee | Annual Fee | |
Establishment registration fee | 3382 | |
2、FDA續(xù)費企業(yè)請于2016年10月1日-2016年12月31日期間繳納年費，逾期將影響貴司產(chǎn)品銷往美國。如果您想繼續(xù)使用FDA的企業(yè)注冊號和設(shè)備登記號，請注意續(xù)費時間并及時申請年費繳納事宜。
3、想進行首次FDA注冊的制造商或貿(mào)易商如需我司協(xié)助，請致電：021-31006127，13512157337、18202148021或發(fā)郵件至zhaoyuan0520@163.com.（趙園）
上海句峰隨時為您提供最專業(yè)的注冊服務(wù)！
