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Medical device components from Vietnam
Housings, instrument parts, fixtures and sub-assemblies for device makers. We look for factories whose quality system and traceability already fit medical work, and we check the paperwork against the issuer, not a photocopy.
What changes when the part is medical
A medical part is judged on records as much as on the part itself. The factory has to show which material lot went into which batch, who inspected it and how changes are controlled. A shop can machine a beautiful part and still fail the audit on paperwork.
Vietnam has a smaller medical supply base than its CNC or electronics base, so the shortlist is often short. We would rather send you one factory that fits than three that will need a year of corrective actions.
What buyers source here
- Device housings and covers, metal and plastic
- Surgical and dental instrument components
- Orthopedic trial and instrument parts
- Lab equipment and diagnostic machine parts
- Assembly fixtures and test jigs
- Molded plastic parts and small sub-assemblies
Processes and materials
The usual routes in this sector. Send your drawing if yours is different; we check the fit part by part.
| Process | Typical materials | What to watch |
|---|---|---|
| CNC turning and Swiss-type turning | SUS316L, 17-4PH, titanium Gr5 | Small diameters, tight concentricity |
| CNC milling | Aluminum, stainless, PEEK, POM | Housings and instrument bodies |
| Injection molding | PC, ABS, PP, medical grades on request | Ask about clean molding areas |
| Passivation and electropolishing | Stainless | Per the spec on your drawing |
| Laser marking | Metals, plastics | UDI and lot marking |
What we check at the factory
On top of our standard audit (registration, machines on the floor, capacity, references), these are the points that matter most in this sector.
Quality system in practice
If the factory claims ISO 13485, we check the certificate with the issuing body and its scope. Then we check whether the floor follows it: lot records, change control, nonconformance logs.
Lot traceability
We pick a past job and trace it from raw material to shipment. If that takes a day of searching, it is not a medical supplier yet.
Material control
Medical grade material kept apart from general stock, with certificates matched to bars or resin lots.
Cleaning and packaging
How parts are cleaned after machining and how they are packed. Final cleaning and sterilization usually stay with you, and we make that split clear in the brief.
Documents that come with the parts
We agree the document list with you before production, so nobody argues about it at shipment.
- Material certificates per lot
- First article inspection report
- Lot traceability record
- Process change notification agreement
- Passivation or finish certificates
Tell us about your medical devices project
A thirty-minute call, no obligation. We review your drawings and tell you whether Vietnam fits and which type of factory to look at. Reply within 24 business hours.
- NDA available before any specs are shared
- Two or three factories, or a plain no
- Prefer full detail first? Use the full brief form.
Medical devices: buyer questions
Something else? Email .
Are your factories ISO 13485 certified?
Some factories in Vietnam are and many are not. When a factory claims it, we verify the certificate and its scope with the issuer. If your part needs it, we only shortlist factories where the certificate checks out.
Can a factory in Vietnam handle FDA or MDR audits?
A factory can support your audit with records and access. Registration and regulatory responsibility stay with you. We tell you up front how audit-ready each shortlisted factory is.
Can we start with prototypes?
Yes. Many buyers start with a small first article run to check the factory before moving a production part.