***器械FDA注册
1、2017年***器械企业的FDA年费为3382美金。
这也是近三年来FDA年费***降价。如下所示。
|
Application Type |
Standard |
***all 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 ***all business. If this is the only fee you expect to pay during FY 2017,doyou submit an FY 2017 ***all Businesss Qualification and Certification request. |
||
|
Type of Fee |
Annual Fee |
|
|
Establishment registration fee |
3382 |
|
2、FDA续费企业请于2016年10月1日-2016年12月31日期间缴纳年费，逾期将影响贵司产品销往美国。如果您想继续使用FDA的企业注册号和设备登记号，请注意续费时间并及时申请年费缴纳事宜。
3、想进行***FDA注册的制造商或贸易商如需我司协助，请致电：021-31006127，13512157337、18202148021或发邮件至zhaoyuan0520@.（赵园）
上海句峰随时为您提供******的注册服务！