Medical devices exported to the United States have FDA certification or have been detained.
Based on our years of experience exporting medical devices to the U.S., we have found that some medical device products are still being held by U.S. Customs even though they have been FDA certified. This usually happens when a non-FDA qualified importer is used, or if the importer information is not provided.
There are two basic conditions that need to be met for medical devices to be exported to the United States in order to clear customs smoothly. First, medical device products must be fully FDA certified, not simply issue FDA claims. Many sellers spend a lot of money to complete FDA certification, but if they do not provide information about a qualified importer, or use an importer who is not FDA qualified, the goods may still be detained.
Therefore, in addition to completing FDA certification, medical devices exported to the United States also need to provide an FDA-qualified importer in the United States. This importer is responsible for customs clearance and tax payment of goods. Only when these two conditions are met at the same time can medical device products successfully enter the U.S. market.
To avoid the risk of being detained, medical device exporters should address all related issues prior to shipment. They need to find a logistics company that can provide dual clearance services, as well as a logistics partner who can assist with FDA-certified and FDA-qualified importers. In this way, they can ship with confidence and ensure that the goods can be cleared smoothly.
If a medical device is detained for export to the U.S., the exporter can take appropriate measures to resolve the issue after understanding the reason for the detention. Partnering with an experienced logistics company can help exporters quickly resolve customs clearance issues and ensure that their products can enter the U.S. market smoothly.