FDA Eases Exporting Unapproved Medical Devices Using Self-Certified Letters
(Thursday, August 25, 2022)
Medical devices not approved for sale in the US can be exported to other countries provided FDA determines that such exportation is not contrary to the public health and safety, and the device has the approval of the foreign country to which it is being exported. The manufacturers of such devices need to obtain an export certificate/permit from the FDA. Requesters of such export permits from FDA need to present to FDA a written importation authorization from the appropriate office within the destination country’s government. However, many US-based exporters may experience logical challenges to obtain such authorizations from foreign governments while being fully aware of the laws for legal importation into the destination country. FDA provides an alternate way for such circumstances. A “responsible company official” in the US can provide a notarized certification that the product being exported from the US is not in conflict with the foreign country’s laws. In this case the entire onus of responsibility to ascertain the legality of the exported product resides with such responsible company official, usually the owner or the major stakeholder in the exporting company. It is a criminal offense for a US person to knowingly and willingly make a false or fraudulent statement, or to use a false document when requesting permits from the US government agencies. Exporters are also responsible to clear such shipments with the customs of the destination foreign countries. FDA works with foreign governments to ensure the integrity of this process of self-certification whereby any complaints by the foreign country or other sources of intentionally fraudulent statements by the US exporter could lead to prosecution of the US individual. The process allows for speedy export permits or certificates from the FDA for devices that can be legally exported even when not allowed to be marketed to consumers in the US.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC