In short: before ordering, verify (1) the business license and medical device manufacturing license, (2) a current ISO 13485:2016 certificate (issuer, expiry, scope), (3) product registrations and regulatory databases (EUDAMED for the EU; NMPA in China), (4) a sample plus a batch COA, and (5) references or an audit. Confirm with documents, not claims.
Due-diligence checklist
- Legal entity: business license and a China Class II medical device manufacturing license for the relevant product scope.
- Quality system: ISO 13485:2016 certificate — check the issuing body, expiry and that the scope covers your product.
- Registrations: EUDAMED SRN (EU) and/or NMPA registration (China); cross-check in the public databases.
- Proof in practice: request a free sample and a certificate of analysis (COA) for a recent batch.
- Track record: years in operation, export references, and a video or third-party audit of the facility.
Red flags
- Vague or unverifiable "CE certified" claims — ask exactly what they hold (DoC vs notified-body certificate).
- No batch COA or release testing; reluctance to share certificates.
- Certificate scope that does not match the product offered.
For reference, see Stripmed's certifications and company background.
Frequently asked questions
How do I check if a manufacturer is ISO 13485 certified?
Ask for the certificate and verify the issuing body, expiry date and scope; many certification bodies offer an online lookup of valid certificates.
Are 'CE certified' claims reliable?
Not always — ask whether they mean an EU Declaration of Conformity (self-declared) or a notified-body CE certificate, and request the document.
Should I order a sample first?
Yes. A sample plus a batch COA lets you confirm material, specification and release testing before committing to a production order.
