BASICS OF IMPORTATION – MEDICAL DEVICES

FDA regulates a range of products which includes food (human and animal consumption), medical products (drugs, devices and biological products), radiation-emitting electronic products, tobacco products and cosmetics. All imported shipments of FDA regulated products are evaluated by FDA and needs to comply with same regulations as of domestic products.  The products that are offered into U.S including personal items must be declared to U.S. Customs and Border Protection (CBP). CBP will refers all FDA –regulated products to FDA for review. Mostly, importers will hire a custom broker to help them in submitting necessary entry documents and applicable payments to CBP on behalf of the importer.  FDA regulated products are refused to enter in US commerce, if they appear to be adulterated, misbranded, or restricted for Sale.   Refused products needs to be destroyed or exported from U.S within 90 days.

MEDICAL DEVICE IMPORTATION

Foreign medical device manufacturers are required to meet applicable US FDA medical device regulations in order to import devices into the U.S although the product is permitted for marketing in another country.  The following are the requirements which FDA checks at the time of importation

1. Medical device establishment registration
2. Device listing
3. Medical Device Labeling
4. Premarket Notification(510K) or Premarket approval(PMA) if applicable
5. GMP Regulations
6. U.S Agent for foreign manufacturers.

The Initial importer of the device are required to register their establishment with FDA.

As per FDA, an initial importer is any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.  FDA medical device establishment registration and listing can be found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

Manufacturers, Initial importers and device user facilities are subject to Medical Device Reporting (MDR) regulation, where they have to report device-related adverse events and problems to FDA. Importers are required to maintain a MDR event file for each adverse event and also they have to forward all product complaints (MDR and non MDR events) to the manufacturer.

Medical devices that are imported into the United States must meet Custom Border Protection (CBP) requirements in addition to FDA regulations.

Liberty Management Group, a leading FDA consulting group in the United States provides assistance with medical device establishment registration, device listing, medical device label review and US agent service for foreign medical device establishment firms.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us