Want to get the FDA-approved tag for your medical device/food item/drug/cosmetic item/ingredient? You will have to plan it in advance to cover the essential requirements established by USFDA. Specific registrations & listing processes will have to be complied with to commercialize your product in the US.
For Non – US establishments of medical devices of IVD devices will have to appoint one US agent.
Maven is all set to guide you with these compliances and play your US agent’s role for your establishment!
Our recognized assets are quality, lead time, dynamicity, flexibility, market needs comprehension, cost-effectiveness; we are eager to say we put the client at the center of our services.
A timely solution of the critical aspects of the project, detailed knowledge of the requirements, and collaboration with the testing facilities allow us to make the effective submission to US FDA, which makes MAVEN the one-stop solution for USFDA submissions/registrations/listings.
For legal commercialization of your product, 510k approval process need to be carried out by choosing the type of 510k and complying to the requirements established by the USFDA.
For all Non-US organizations, who wish to sell their products in US market, will have to appoint US agent as a regulatory requirement.
Facilities that are situated outside the United States that manufacture, process, pack, or store food, beverages, or dietary supplements that are to be consumed in the United States are required to be registered with the U.S. Food and Drug Administration (FDA) by following the 12-steps process of registration.
As per 21 CFR 207, it is manufacturer’s obligation to register and to list their establishments with USFDA before marketing the drugs in the USA.
Voluntary Cosmetic Registration Program (VCRP) is a reporting system of FDA for manufacturer/packer/distributor of cosmetic products to regulate cosmetics/ingredients distribution in the US.
NIOSH must certify any respirator or respiratory protective product before it can be used in any workplace: medical, industrial, educational, etc. The regulation that empowers NIOSH to regulate and certify respiratory protective products is 42 CFR Part 84.
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