When marketing and selling medical devices, pharmaceutical products, cosmetics or foods outside the U.S., your company will be required to have certain regulatory, quality or supporting technical documents authenticated either by apostille or by consular legalization through the embassy of the target country.
The health ministries of countries require assurances that the products entering are safe, effective and in conformance with current Good Manufacturing Practices (CGMPs). Thus, companies are required to submit for review to the ministry copies of the company’s U.S. Food and Drug Administration (FDA) approval certificates such as:
- Certificate to Foreign Government (CFG),
- Certificate of Exportability (COE);
- Certificate of Pharmaceutical Product (CPP)); and its
- International Organization for Standardization (ISO) certification; or
- Free Sale Certificate (CFS) to document that its products are free from defect, disease or harmful nature.
Note: CFG is used by FDA to describe a type of certificate referred to in other countries as a CFS.
To confirm authenticity, these certificates need document legalization, authentication or apostille within the U.S. depending on the national ministry’s requirements. To do this, one can handle it in-house or utilize the expertise of a service specializing in efficiently handling this process.
If you choose to handle it on your own, these six quick tips can help you through the document legalization process!
