Does FDA registration mean FDA approval?
No. Registration is not the same as approval or clearance.
FAQ
Short answers to common FDA market-entry questions.
Use these answers as orientation, then confirm the correct path for your exact product and claims.
Who needs an FDA US Agent?
Many foreign establishments exporting FDA-regulated products to the United States may need a US Agent.
What does MoCRA require?
MoCRA introduced facility registration, product listing, adverse-event recordkeeping, and related obligations for many cosmetic companies.
Can approval be guaranteed?
No. The desk provides consulting, preparation, review, and coordination support. Final determinations rest with FDA.
Can Chinese-language teams be supported?
Yes. Client coordination can be in Chinese while regulatory records are maintained in English where needed.