FAQ
Q1: Do I need FDA certification or registration?
FDA does not “certify” products; it requires registration and compliance. We’ll help you determine which applies to your product.
Q2: How long does FDA registration take?
Typically 1–2 weeks, depending on product type and document readiness.
Q3: Do I need a U.S. company to register with FDA?
No. Foreign manufacturers can register through an authorized U.S. Agent — that’s one of our key services.
Q4: What’s the difference between 510(k) and registration?
510(k) is a premarket submission required for most medical devices, while registration applies to all establishments.
Q5: Can you help with label translation and bilingual packaging?
Yes. We provide compliance review for English and bilingual (e.g., Chinese/English) labels.
Let us together build a flourishing business
When connected with us, you aren’t growing your business alone. We have your back and put in our best to contribute to the entrance of your company products to the U.S. market. So, if you are looking for the right agency that’ll help your products meet FDA compliance fast, we are right here!