Many US distributors visit MEDICA to find new instrument suppliers. Before you import, check that your supplier and products meet US Food and Drug Administration (FDA) rules.
This is a short overview, not regulatory advice. Check FDA guidance or speak to a US regulatory consultant.
FDA classification
Most manual surgical instruments, such as scissors, forceps and retractors, are Class I devices. Many of them are exempt from 510(k) premarket notification. Some instruments and kits fall into higher classes and need more.
Always check each product’s classification in the FDA database.
What the manufacturer needs
- Establishment registration: Foreign manufacturers must register with the FDA every year.
- US Agent: Foreign firms must name a US Agent.
- Device listing: Each product type must be listed.
- Quality system: Manufacturers must follow FDA quality system rules.
What you need as an importer
- Your own establishment registration as an importer, where required
- Correct labelling, in English, with the manufacturer’s details
- UDI (Unique Device Identification) on labels, where required (see Laser marking and UDI: tracking surgical instruments explained)
- Complaint handling and records
Questions to ask suppliers
- Are you FDA registered? What is your registration number?
- Who is your US Agent?
- Are these products listed with the FDA?
- Can you label with UDI?
US buyers welcome at Tata Surgical
Talk to us about supply to the US market at Hall 10, Stand C32.
Looking for instruments like these?
Browse our catalogue or send us your drawing. We reply with prices, lead time and shipping terms.
