Preparing to Export to the U.S.? What Changed After MoCRA, Summarized on One Page

In practice, the step that tends to take the longest is not facility registration or product listing itself, but gathering the necessary materials beforehand and deciding who will be responsible. In particular, if it takes time for the Korean manufacturer and U.S. distributor to agree on who will be named as the Responsible Person in the U.S., and who will retain and manage the safety substantiation materials and adverse event procedures, the rest of the schedule gets delayed too.

MoCRA does not require blanket “FDA pre-approval” for every product, but you do need to take care of facility registration for applicable facilities, product listing, safety substantiation records, and serious adverse event reporting, among other things. Exemptions or exceptions may apply to facility registration and product listing, and requirements may change, so it’s safest to check the latest FDA guidance and whether the rules apply to each product.

A practical tip: gather the full ingredient lists, labels, and safety materials for each SKU in one place, and specify the U.S. Responsible Person and the process for receiving and reporting adverse events in the contract upfront. Once these two things are sorted out, the submission process is much less likely to get tangled. What took the longest for you: interpreting the regulations, or coordinating roles between partners?