Exporting medical devices from the United States often requires a certificate for products regulated by the FDA. An export certificate gives information from the FDA on the product’s regulatory status. The FDA has revised medical device export certificates fees for the second time since the program began in 1996. Medical device export certificate processing costs have gone up over … Read More
Export Certificates and CDRH
The CDRH has released a letter stating that as of March 1, 2014 they will no longer be notarizing FDA CDRH export certificates. The FDA is not under any obligation to provide this service but they have been fulfilling this role. These notarized documents from the FDA have been official and have needed no further action for verification. If you … Read More