For Manufacturers
What is a 510(k)?
A 510(k) is a U.S. FDA premarket submission pathway used for many medical devices when a manufacturer seeks to demonstrate substantial equivalence to a legally marketed predicate device.
What is a U.S. Agent?
A U.S. Agent acts as the FDA point of contact for foreign establishments and helps relay communications and registration-related information.
What does “importer-ready” mean?
Importer-ready means the product, documentation, labeling, claims, and commercial handoff are organized enough for structured U.S. market-entry and distribution conversations.
How long does U.S. market entry usually take?
Timing depends on the product category, documentation status, regulatory route, importer readiness, distribution pathway, and buyer requirements.
What documents do I need before contacting AvAm Global Med?
Helpful starting documents include product description, regulatory status, intended use, labeling/IFU, technical documentation, existing certificates, and current market history.
For Hospitals & Buyers
How do we request product information?
Use the Contact / Start Request page and select your organization type, product interest, urgency, budget range if applicable, and whether you need demo or procurement support.
How does AvAm Global Med vet overseas products?
AvAm reviews product category, intended setting, available documentation, regulatory status, clinical relevance, and buyer fit before progressing conversations.
What regulatory status do your products have?
Regulatory status varies by product and may include CE, FDA cleared, pending, exempt, or other category-specific documentation status shown on each product entry.
How do clinical demos work?
Clinical demos are coordinated according to product type, clinical setting, buyer needs, manufacturer availability, and applicable documentation requirements.