How to Verify an IVD Certificate
Direct answer: Verify an IVD certificate by confirming three things — the certificate is in the supplier's own name, the issuing body is legitimate, and the registration/certificate number can be cross-checked against the issuing authority's database. A certificate that fails any of these is not evidence.
How to verify each certificate type
- ISO 13485 — check the certification body (e.g., a recognized registrar), the scope, and the certificate number against the body's public directory.
- CE marking — check the conformity procedure: Annex III self-declaration (no Notified Body) vs a Notified Body number for higher classes. Request the EC Declaration of Conformity and the authorized representative.
- FDA — distinguish device listing (establishment registration) from 510(k) clearance. A 510(k) has a K-number you can look up in the FDA database; a listing is not a clearance.
- NMPA — a registration number (注册证编号) is checkable against the NMPA database.
Red flags
- Certificate in a different company's name.
- No certificate number, or a number that does not resolve.
- "FDA approved" or "FDA cleared" without a 510(k) K-number.
- An expired certificate or one that does not cover your product.
The Author's Take
Position: In my view, "we have CE and ISO" is not verification — the certificate number and the issuing body are, and a buyer who does not cross-check them is accepting a logo instead of evidence.
Reasoning: Certificates are easy to copy and hard to verify, which is why the number and the holder name matter more than the logo. A supplier who can produce the number and point you to the issuing body's directory is a supplier whose certificates you can trust.
Disclosure: This is my editorial view as an IVD manufacturer's regulatory team, not a legal statement.
By Progene Bio Regulatory Affairs Team · Medical disclaimer · Last reviewed: 2026-09-13