Planning to export an ancillary supply or a medical device? Get ready for some bureaucratic red tape.

Country governments take compliance with their import and export laws and regulations seriously. If a violation occurs, the in-country importer of record could find itself facing fines, penalties, and shipment delays.

To stay compliant and to ensure a smooth process, don’t overlook the importer of record. This is an established business or other type of legal entity in the country of import recognized by the country’s government as the official party of an international shipment transaction. The importer of record will act as the government-responsible party in conducting import transactions.

Your registered importer of record is responsible for hands-on support, including:

• Assigning a customs broker to clear the import.
• Paying the required duties and taxes based upon the international commercial terms (INCOTERMS) used for importation.
• Filing specific declarations with various government agencies upon importation.
• Obtaining necessary licensing, certification, and authorizations to export, in many cases prior to exportation.

All of the above is useful information, but it turns out that not all countries handle imports this way. Some countries have a much narrower definition of who can be the importer of record. In others, third parties such as CROs or distributors are allowed to serve that role.

Importing and exporting is a task full of big and small details, so make sure you’re working with experts who are knowledgeable about all the regulations. If you are using a shipping vendor, make sure they will work with your assigned registered importer of record and assist with your door-to-door delivery.

Early planning, as well as communication among everyone — your assigned registered importer, assigned broker, and shipping vendor — is essential. And a strong working relationship between your importer of record, country customs, and shipping vendor is also necessary to ensure your ancillary supplies or medical devices reach their destination and can begin to take on their important role in research.