FDA-Registered Initial Importer
Every medical device shipped to the United States must be cleared for compliance by Food and Drug Administration (FDA) officers at the port of entry. Improper paperwork, company registration, or coding can cause serious setbacks to clinical trial and commercialization efforts.
To ensure that your product arrives on-time and is usable in the US, Tanasi Medical Logistics partners with Medical Device Post Production Services (MDPPS), an FDA-licensed initial importer whose founder and staff have decades of expertise in medical device development, software verification, and risk assessment. MDPPS serves as a reliable interface between your device manufacturers and the FDA—both at ports of entry and with the FDA themselves.
Tanasi’s partnership with MDPPS means that you can count on your medical device being covered by robust SOPs that address every possible contingency, including customer complaints and medical device reports (MDRs). MDPPS also ensures that manufacturers are registered with the FDA, and coaches your manufacturers on how to consistently create accessible and FDA-compliant labeling so your shipments are never held. Additionally, MDPPS’s credentialed access to FDA electronic systems ensures that all communication with the FDA is expedited and routed appropriately.
What does all this mean for you? Simple—the peace of mind that comes with knowing your product is in the best hands possible. Contact us today to see how we can solve your importing issues.