Importing Medical Devices

Medical devices imported into United States need to comply with FDA regulations. Prototypes for testing purposes do not need FDA registration.  When entering the United States, they need to be cleared by FDA before distribution for testing.  FDA may need a letter explicitly stating these products are testing prototypes not sold to the general public.…

Importing Lasers

Laser are regulated by the FDA and subject to radiation control standards: Click here for more information The laser pointers in particular are watched carefully by the FDA: Click here for more information Importers should register their establishment with FDA. The manufacturer should also register their establishment and likely need to file a listing with FDA. If the…