mdi ConsultantsNEWS FLASH!!!
For those of those that ship FDA regulated devices out of the country we are familiar with export certificates. FDA has revised the payment requirements for export certificates, the fees are now:
- Original Certificates: $175
- Subsequent Certificates issued for the same product(s): $85
The maximum number of pages for a certificate is now 25 pages. If the request is more than 25 pages, then the total number of pages created by the request is divided by 25 and that number will be the number of original certificates that will be charged at $175 and the remaining number of subsequent certificates will be charged at $85 each. For example, if you request 15 certificates and each certificate has 12 attachment pages plus the certificate page that means each certificate is 13 pages, and your request will generate 195 pages in all. This number of pages is divided by 25 and that equals 7.8, which is rounded to 8. Therefore, you will be charged for 8 original certificates at $175 each and 7 subsequent certificates at $85 each.
mdi can provide assitance with Export Certificates to be supplied to the FDA for your products and have been helping out a lot of clients (domestic and international) with this service.
?For any questions regarding the rule please contact us at [email protected] or use or contact info form. REf: Export Certificates