US FDA Registration Service for Medical devices

Medical devices as per Food Drug and Cosmetic Act denotes instruments, machines, equipment, implants for diagnosing, curing & treating, alleviating as well as preventing diseases. It must not include any chemical action on or into the body. FDA never considers the regulatory authorizations from foreign nations when it comes to Medical devices. Medical devices produced by non-U.S companies must comply with the precise standards laid by the U.S government.

They must be accurately labeled as well as compulsorily registered with FDA as per the FDA Medical Device Establishment Registration regulations. It is obligatory for them to every company to get the pre-clearance prior to importing the products to U.S.

It is essential for such companies to assign a U.S. Agent for these procedures. We work in affiliation with Register-FDA Company, and help our clients in this process of getting approved and certified by FDA. We stand by our clients throughout the process of functional clearance, labeling as well as listing offering them proper examination and complete guidance. We are the most trust-worthy US FDA Registration Service providers.