Medical Devices

Medical-Grade Precision.
Vietnam-Grade Pricing. Zero Tariffs.

Surgical instruments, orthopedic components, diagnostic housings, and disposable device parts — from Vietnam's ISO 13485-capable factories. Full traceability documentation. Zero Section 301 tariffs.

ISO 13485-capable · FDA documentation support · Full lot traceability · 50-point Dolphin audit

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Why Medical Device Buyers Source From Vietnam

The medtech industry faces simultaneous pressure on cost, quality, and supply chain risk. Vietnam offers a way out of all three.

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40–60% Lower Than US

Vietnam machining and injection molding costs are a fraction of domestic rates. In many cases, the savings fund the entire product validation and regulatory pathway — with money to spare.

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Zero Section 301 Tariffs

China-origin medical components face 7.5–25% Section 301 tariffs on top of standard MFN rates. Vietnam pays only MFN — typically 0–3.7% for machined metal parts. The tariff advantage alone often justifies a supply chain transition.

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ISO 13485 Capability

Our medical-capable factories hold ISO 13485:2016 certification and already supply Japanese, German, and US medtech OEMs. Documentation systems, traceability protocols, and quality records are designed for FDA audit readiness.

The Section 301 Tariff Impact on Medical Components

Real cost comparison: China vs Vietnam for common medical device component categories.

CNC Machined Surgical Instrument (17-4PH SS, passivated, qty 500)

US Domestic
$95–140 ea
China + Tariff
$38–55 + 25% tariff = ~$47–69 ea
Vietnam (Dewin)
$28–42 ea
vs China
est. 40–45%

Injection Molded Disposable Housing (PC, Class VI, qty 10,000)

US Domestic
$3.80–5.50 ea
China + Tariff
$1.40–2.10 + 7.5% tariff = ~$1.51–2.26 ea
Vietnam (Dewin)
$1.05–1.65 ea
vs China
est. 27–30%

Ti-6Al-4V Orthopedic Component (CNC, electropolished, qty 100)

US Domestic
$280–420 ea
China + Tariff
$110–160 + 25% tariff = ~$137–200 ea
Vietnam (Dewin)
$85–125 ea
vs China
est. 38–42%

Stainless Steel Diagnostic Enclosure (316L, laser cut + welded, qty 200)

US Domestic
$185–260 ea
China + Tariff
$72–100 + 25% tariff = ~$90–125 ea
Vietnam (Dewin)
$58–82 ea
vs China
est. 34–36%

Prices are est. per-piece at listed quantities. Actual pricing depends on geometry, tolerances, volume, and finishing requirements. Get an exact quote.

Medical Applications We Manufacture

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Surgical Instruments

  • ✓ Forceps, retractors, clamps
  • ✓ Scissors and needle holders
  • ✓ Endoscopic components
  • ✓ Custom surgical tools

CNC machining · passivation · electro-polishing

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Orthopedic Components

  • ✓ Bone plates and screws
  • ✓ Spinal fixation rods
  • ✓ Instrument trays
  • ✓ Trial implant components

Ti-6Al-4V and SS316L · ±0.005mm tolerances

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Diagnostic Device Housings

  • ✓ Analyzer enclosures
  • ✓ Point-of-care device shells
  • ✓ Lab instrument housings
  • ✓ Sensor housings

CNC machining · sheet metal · injection molding

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Disposable Components

  • ✓ Syringe barrel assemblies
  • ✓ Catheter connectors
  • ✓ IV set components
  • ✓ Blood collection parts

Injection molding · ISO 10993 materials · AQL 1.0

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Capital Equipment Parts

  • ✓ Imaging system brackets
  • ✓ Patient monitoring mounts
  • ✓ Therapy device housings
  • ✓ Ventilator components

Sheet metal · CNC machining · powder coat

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Dental Instruments

  • ✓ Dental handpiece components
  • ✓ Orthodontic hardware
  • ✓ Implant abutment blanks
  • ✓ Tray and handle components

CNC turning + milling · mirror polish available

Quality & Compliance Framework

QMS

ISO 13485:2016

Our medical-grade factories hold ISO 13485 certification with documented quality management systems, change control, and CAPA procedures designed for FDA audit readiness.

FAI

First Article Inspection

Full dimensional inspection with balloon drawing, CMM report, material certification (EN 10204 3.1), and surface finish verification. All measurements on calibrated Zeiss or Mitutoyo CMMs.

LOT

Lot Traceability

Every batch: raw material traceable to mill cert, heat number, in-process inspection records, final QC, and CoC. Retained per FDA 21 CFR Part 820 requirements (min. 2 years).

MAT

Biocompatible Materials

Ti-6Al-4V ELI (ASTM F136), 316L SS (ASTM F138), 17-4PH, PEEK (ISO 10993 tested), Ultem, USP Class VI polycarbonate. Material certs provided with every order.

SURF

Medically Acceptable Finishes

Passivation (ASTM A967/A380), electropolishing (Ra ≤0.4µm), hard anodizing (Type III), clean-room packaging, validated cleaning procedures. Finish certs provided.

NDA

IP Protection

Bilateral NDA with every factory before drawings are shared. Design files compartmentalized — no factory sees competing customers' IP. Vietnam's IP framework aligns with TRIPS obligations.

Calculate Your Tariff Savings

See exactly how much you'd save switching your medical component sourcing from China to Vietnam — including Section 301 elimination and per-piece cost reduction.

Run Tariff Assessment →

Frequently Asked Questions

Can Vietnam factories meet FDA and ISO 13485 quality standards? +
Yes. Our network includes factories with ISO 13485:2016 certification and FDA-compliant documentation systems. These factories supply components to medtech OEMs in Japan, Germany, and the US. We provide full traceability packages including material certs (EN 10204 3.1), first article inspection, dimensional reports, and Certificate of Conformance documentation required for FDA 21 CFR Part 820 compliance.
What medical device components can you source from Vietnam? +
Surgical instruments (forceps, retractors, clamps, scissors), orthopedic components (bone plates, spinal rods, instrument trays), diagnostic device housings and enclosures, injection-molded disposable components, and precision-machined implant-adjacent parts. We manufacture from titanium (Ti-6Al-4V), surgical stainless (17-4PH, 440C, 316L), PEEK, Ultem, and Delrin.
What tariff savings are available on medical devices from Vietnam? +
China-origin medical device components face Section 301 tariffs of 7.5–25% depending on HTS classification, in addition to standard MFN rates. Vietnam-origin components pay only the standard MFN rate — typically 0–3.7% for metal machined parts (HTS Chapter 84/90), and often 0% under CPTPP for qualifying buyers. On a $500K annual import program, that's est. $37,500–$125,000 in annual tariff savings.
How do you ensure traceability for medical parts? +
Every batch includes a full documentation package: raw material certificates traceable to the mill, in-process inspection records, final CMM reports, surface finish (Ra) verification, hardness testing, and serialized part marking (laser engraving or chemical etching). Lot traceability records are maintained and available for FDA audits.
What tolerances can you hold for medical-grade machining? +
Standard precision machining: ±0.005mm. For implant components requiring tighter tolerances, ±0.002mm is achievable on 5-axis machining centers (Mazak Variaxis, DMG Mori). Surface finish to Ra 0.4µm (mirror polished) on stainless steel and titanium. All measurements verified on calibrated CMMs (Zeiss, Mitutoyo).
What are typical lead times for medical device components? +
CNC machined prototypes (1–10 pieces): 2–3 weeks. First article production run: 4–6 weeks. Repeat production orders: 3–5 weeks with established tooling. Injection-molded components with new tooling: 6–10 weeks. Expedited schedules available for validated suppliers.
Are your factories subject to regulatory audits? +
Yes. Several factories in our medical-capable network are regularly audited by their OEM customers under ISO 13485 supplier qualification requirements, and some hold FDA-registered facility status. DEWIN's 50-point Dolphin audit supplements these with additional checks specific to medical manufacturing: clean room access, traceability systems, calibration records, and biocompatibility material sourcing.

Medical-Grade Parts. No China Tariffs.

Send us your drawings, material specs, and quality requirements. We'll match your parts to an ISO 13485-capable factory and return a detailed quote with DFM feedback and documentation plan within 48 hours.

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