Initial Importer
MDPPS is a registered initial importer with the FDA and as such we are authorized to facilitate the marketing of devices from a foreign manufacturer to the person who makes the final delivery or sale.
As your designated initial importer, MDPPS will
- Report to FDA any incident where there is a malfunction, serious injury or death.
- Maintain an MDR event file for each adverse event.
- Forward all product complaints (MDR and non-MDR events) to you and if desired, your contract manufacturer.
If you are interested in our initial importer services, contact us today to setup a free consultation about how we can assist you.