Importing Radiation Emitting Medical Devices
To import radiation-emitting products you should first understand what these products are and their requirements (FDA)
Radiation emitting products run the gamut from diagnosing serious medical conditions through such things as X-rays and mammograms to helping ensure the safety of airports and office buildings with security X-rays to making modern life a little easier with microwave ovens and cell phones. Dawa medical can assist with importing radiation emitting medical devices.
Not everyone is aware of the regulations.
The FDA is very clear: if your product is a radiation-emitting electronic product as any electrically-powered product you will have to disclose this when the shipment enters the USA.
Here some examples that constitute a radiation-emitting product :
- mammography devices,
- magnetic resonance imaging (MRI) devices,
- liquid crystal displays (LCDs),
- light-emitting diodes (LEDs)
Radiation-emitting electronic products are regulated by FDA and are required to comply with the general requirements found in 21 CFR 1000-1005.
Radiation emitting electronic products subject to U.S. Federal Performance Standard require submission of Form FDA-2877, Declaration for Imported Electronic Products Subject to Radiation Control Standards, at the time of entry.
Products not subject to federal performance standards do not require a Form FDA-2877 for importation into the US. At the time of importation, FDA will verify the declarations submitted on Form FDA-2877
Read: Initial Importer