Class I medical devices are easier to import in the United States than devices in other regulatory classes. Nonetheless FDA CDRH regulation can prove difficult. ExportUSA can help companies obtain authorization to export their products in America







How to register a class I medical device


ExportUSA can help companies in the FDA CDRH registration procedure



 
On the whole, class I devices are characterized by the low level of risk involved in their use. This makes the procedure quicker and simpler than that required for higher classes. 
 
Class I devices are eligible for:
 
  1.  pre-marketing notification exemption, required for Class III products.
  2.  74% of the cases are exempt from presenting a 510(k) pre-marketing notification, which is required for most class II and class III products.
 
ExportUSA can help a company verify whether its product is eligible for exemption.
 
If the product does not require a 510(k) pre-marketing notification, it must still observe all other FDA specifications. Labeling requirements are especially important. ExportUSA offers consulting services for companies interested in learning more about FDA requirements for medical devices.
 
FDA registration is required for all companies producing and selling medical devices in the United States. 
Depending on what kind of activities the company carries out, it may be exempt from paying the annual registration fee and declaring or describing the items it plans to sell.
 
Finally, once the product enters the market, the registered firm will be responsibile for meeting the  Good Manufacturing Practice (GMP) requirements of the Quality System regulation. The latter comprises labeling, design, packing and manufacturing of the item. It also requires that a Medical Device Reporting system be set up to facilitate reporting of malfunctioning devices.