COVID-19

ATTENTION TO THE MANUFACTURERS WHO PRODUCE MASKS, GOWNS, OVERALLS AND DISINFECTANTS ETC. WITHIN THE SCOPE OF covid-19!

During Covid-19 pandemic many textile and cosmetic manufacturers changed their production lines and machine configurations to produce masks, gowns, coveralls, face shields, hand sanitizers and other healthcare products to help fulfill the shortage that U.S. government, cities and private companies are experiencing.
It’s important for manufacturers to knowthat exporting these products to the U.S. require FDA registration. Manufacturers that do not abide by the FDA regulations can have their shipments held at the U.S. customs, be subject to monetary penalties and have their shipments returned or seized by the U.S. customs office. In order to make sure that the exporters do not experience any problems with their medical products entering the U.S., we suggest that they read the FDA requirements carefully.

EXPORT OF MASKS, OVERALLS AND PROTECTIVE COVERALLS

Medical Masks, Surgical Gowns and protective coveralls are considered class I or class II medical device in the U.S. and they are regulated by the FDA. Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States(U.S.) are required to register annually with the FDA. Most establishments that are required to register with FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also submit the FDA premarket submission number (510(k), PMA, PDP, HDE).

FDA requirements for export:
-Medical Device Facility Registration
-FDA annual registration and government fee remittance
-U.S. agent appointment
-Medical Device product registration
-Medical Device Label Review

EXPORT OF HAND SANITIZERS AND DISINFECTANTS

Hand Sanitizers and disinfectants are classified as Over the counter (OTC) drug products in the U.S. and they are regulated by the FDA. Domestic and foreign establishments that manufacture, repack, or re-label drug products to be sold in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. Drug products that are not properly listed as required are misbranded and may be subject to regulatory action. Drug establishment registration and drug listing information have, until now, been submitted using a paper-based format, i.e., Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment),

Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments' Report of Private Label distributors). Changes in the Act, resulting from the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) (FDAAA), require that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted.

FDA Requirements for export:
-Drug Establishment Registration
-U.S. Agent appointment
-FDA registration number application
-Drug Listing
-Label review