As importers seek to fulfill an increased need, the FDA has increased its scrutiny on some imported health products. The FDA is exercising additional caution to identify counterfeit and unsafe products, such as hand sanitizer, antibacterial products, medical masks, and thermometers.
To be imported legally, hand sanitizer and antibacterial products must be FDA registered, manufacturers and foreign exporters must be registered, and products must have a valid NDC with a label bearing accurate drug facts. Medical masks and thermometers are considered medical devices; therefore, they must be registered as an FDA medical device and have a device listing number.
If you have specific questions concerning the compliant-entry of FDA-regulated goods, please contact Deringer’s Compliance Department.