When you’re shipping medical devices to a foreign destination, it’s important to understand the rules in the countries of both export and import.
Federal Food, Drug, and Cosmetic Act
Products approved by the FDA may be exported anywhere in the world without prior notification or approval from the government agency. However, devices that have not been cleared in the United States must adhere to export provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act.
In the foreign nation at the other end of your shipment, you may need additional proof to the foreign government about certification and permits.
Certificate to Foreign Government
The FDA can provide an export certificate that includes pertinent information regarding a device’s legality as well as regulatory and marketing status in the United States.
According to the FDA, a Certificate to Foreign Government is the most frequently requested type of export certificate. A Certificate of Exportability may also be prepared upon request, and is required when shipping devices under Sections 801 (e)(1) and 802 of the FD&C Act or when exporting Non-Clinical Research-Use-Only Devices.
Streamline the process
In today’s market time is money, and luckily the FDA boasts the CDRH Export Certification and Tracking System (CECATS) that offers online tracking and tracing providing real-time shipment visibility. Other benefits include the ability to request forms online as an alternative to paper documents, reducing certificate processing time, savings on material and mailing costs for paper applications, real-time validation of firm-specific data, and status updates.
With so many legal barriers to cross when shipping medical devices abroad, it’s a good idea to enlist the help of trusted professionals. At ICAT Logistics, Detroit, we utilize technology and a massive domestic and international logistics network to solve complex problems and meet challenges of any size.
Want to learn more about shipping medical devices abroad? Contact ICAT Logistics today!