FDA regulates medical devices and products for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Firms involved in manufacturing, packaging, labeling or reprocessing of medical devices must pay an annual fee to the FDA. Many establishments that are required to register with FDA also are required to list their devices.
Register the company: 100€
Be the registered agent: annual fee 400€ (2 year payment required)
Listing devices: 150€
Medical devices labeling:
DDC helps companies to modify medical device labeling to comply with FDA regulations. We provide revised graphic files for you ready for print or edition. We also provide a report that details the regulations, compliance guides and other guidance documents from FDA.
Report and labeling assistance: 1200€ with important discounts for large quantities
Electronic Medical Device Reporting (eMDR)
Medical companies are required to submit adverse event reports in electronic format. Device manufacturers and importers are required to submit adverse event reports to FDA when evidence suggests that malfunctions would likely contribute to risks of injury for the patient.
Free service for our clients.
(UDI) y (GIDID):
Some medical devices are required to include a numeric or alphanumeric code as a unique device identifier (UDI). FDA also requires submission of device and UDI information to the Global Unique Device Identifier Database (GUDID).
Data Universal Numbering System:
(MAF) Maestros de dispositivos médicos:
A Medical Device Master File is a submission to FDA. It may be used in support of premarket submissions to provide confidential detailed information about establishments such as: processes, articles used in the manufacturing, processing, packaging, and storing medical devices. DDC provides guidance as to required elements, formats, and particularities of Medical Device Master File submissions.
FDA does not provide a certificate of registration. However, DDC as your registered agent may provide this certificate as you may be asked by your customers and suppliers to verify your FDA compliance and registration.
If your product is of interest to us, we may propose to sell it for you in the USA for a commission to be agreed upon. In this case we pay for some of the administrative expenses above listed.