Manufacturers and importers of medical devices established in the European Union are finding more and more possibilities of exporting these products to third countries. Currently, the American countries are the ones that are showing the most interest in medical devices marketed in the European Union.
Indian companies searching distribution, import, and manufacture of sanitary products are finding great business opportunities exporting their sanitary products with CE markingto countries such as Chile, Mexico, Argentina, Venezuela, or Colombia since the export procedures are accepted with the European CE marking.
They are reduced to obtaining a certificate of free sale for medical devices once the communication of the placing on the market of class IIa, Class IIb, and Class III medical devices.
These free sale certificates are issued by some Chambers of Commerce.
For the export of medical devices to the United States, it is mandatory to register the product with the FDA (Food and drug administration), for this it is necessary to provide documentation similar to that needed to prepare the Technical File that is prepared to obtain the CE marking.
Depending on the product (class I, II, and III) the FDA will require prior authorization for its marketing (PMA, premarket approval) for class III medical devices that have a higher risk associated with their use and simply a prior notification to the marketing Premarket Notification, 510k.
Once the appropriate process has been carried out and the authorization by the FDA (Acceptance Review) has been obtained, the manufacturer must mark the product with the FDA marking, which demonstrates that the product is safe and effective for its intended use and can be exported to the United Stateswithout the need for a certificate of free sale.
To know more about FDA Registration and other regulatory services. Kindly visit the www.i3cglobal.com website
