US FDA Registration – FDA Registration Certificate
FDA Registration is mandatory to market food, drug, and medical device in the USA. FDA Registration is for the establishment or facility, not for each product. Also, FDA registration does not denote FDA approval of your facility or establishment. FDA will not issue a registration certificate after completing the registration. LMG will issue an FDA Registration Certificate for our clients for their records. Our clients and their customers can verify the FDA Registration Certificate status on our website. LMG provides FDA Agent service to foreign food, drug, medical device, and cosmetic establishments.
Food Facility Registration
If you are a manufacturer or processor of food products marketed in the USA, you must register each manufacturing facility (location) with the FDA. FDA will assign an eleven-digit registration number to each facility; you need this registration number to prepare the shipping documents. To register your facility with FDA, please complete our online form https://fdahelp.us/food-form.html
Medical Device Registration
Medical device manufacturers are required to register their establishment with FDA; after registration FDA will assign the owner/operator number immediately, and this number is good enough to start marketing, FDA will assign a registration number (FEI) later. Please complete our online form for medical device registration https://fdahelp.us/md.html
Drug Establishment Registration
Drug establishments which having activities like manufacturing (including contract manufacturing), processing, packing, re-packing, labeling, re-labeling, etc. require FDA establishment registration. Drug manufacturers and labelers require an NDC labeler code and drug listing also. To register your establishment with FDA, please complete our online form at https://fdahelp.us/drug-registration-form.html
Cosmetic Establishment Registration
Establishment registration is not mandatory for cosmetic products; if your product is already in the US market, you can participate in FDA’s Voluntary Cosmetic Registration Program (VCRP). VCRP is a registration program only for manufacturers whose product is available in the USA, labeler or distributors cannot register with VCRP.