Market · Medical Device Packaging

Custom Medical Device Packaging for Healthcare Manufacturers.

Flexible packaging for medical devices, disposables and healthcare products. Sterile barrier films, custom print, ISO 9001 & ISO 14001 certified, FOB Xiamen.

50+
Years in Medical Packaging
High
Barrier Structures
ISO 9001/14001
Certified
SKU · MED-001
PA/PE · PET/AL/PE
Custom medical device packaging with pa/pe · pet/al/pe · sterile barrier, high-barrier · iso 9001 and iso 14001 certified · iso 11607 materials
PA/PE · PET/AL/PE · Sterile Barrier
HIGH-BARRIER · ISO 9001 & ISO 14001 · ISO 11607 MATERIALS
01 — Overview

Medical device packaging is flexible packaging engineered to maintain sterile barrier integrity from the point of manufacture through to the point of use. Tansox manufactures high-barrier flexible packaging for medical device and healthcare product manufacturers — including rollstock film and sachet formats — in nylon, foil laminate and transparent barrier structures compliant with international medical packaging standards.

02 — What medical packaging needs

Three things medical device packaging gets judged on.

Medical packaging must maintain sterility, satisfy regulators in multiple jurisdictions and carry traceability data for the full product lifecycle. Here's how we engineer for each.

Sterile Barrier Performance

Medical packaging must maintain sterility from production through to point of use, requiring validated high-barrier structures with tested seal integrity.

PA/PE · PET/AL/PE · Seal integrity tested

Regulatory Compliance

Packaging for medical devices must meet ISO 11607, ASTM F2475 and regional regulatory requirements covering materials, sealing and labelling.

ISO 11607 · ASTM F2475 · REACH

Traceability and Labelling

Medical packaging requires clear lot number, expiry date and regulatory marking areas designed into the print artwork from the outset.

Lot traceability · Expiry marking · GS1
04 — Special Finishes

Premium finishes for medical and healthcare packaging.

Differentiating finishes used by medical device brands for premium retail and OEM packaging — applied to outer-layer film structures.

Spot UV
F-01
Aluminized
F-02
Brushed
F-03
Hot Stamp
F-04
Soft Touch / Matte
F-05
3D Emboss
F-06
05 — Material Structures

High-barrier, sterile-ready.

Standard structures for medical device packaging. Share your device type, sterilisation method and target market — we'll propose a validated structure.

Tech Drawing
Technical construction diagram of medical packaging showing dimension callouts and seal lines
REF · DWG-MED-2025
  • Common Structures
    PET / AL / PE PA / PE (Nylon/PE) PET / AL / RCPP BOPA / RCPP Tyvek + PE
  • Print Method
    Flexographic & gravure printing, up to 12 colours. Pantone-matched, with G7 process control on gravure lines.
  • MOQ
    10,000 units per SKU (confirm with sales). Rollstock film quoted by reel — confirm with sales.
  • Sample Lead Time
    10–20 days printed · 5–10 days unprinted.
  • Shipping Terms
    FOB Xiamen · FOB Quanzhou · EXW. FCL, LCL and air freight all available.
06 — Why Tansox

Why medical device manufacturers choose Tansox.

50 Years in Medical & Hygiene Packaging

Deep experience with sterile barrier flexible packaging for medical device manufacturers since ~1976. Three generations of operators, 220-person workforce in Quanzhou.

Est. 1976 · Quanzhou, CN

ISO 9001 & ISO 14001 Certified

Tansox operates ISO 9001:2015 and ISO 14001:2015 certified management systems, issued by EACC and accredited by CNAS under the IAF Multilateral Recognition Arrangement. Full lot traceability from raw material to finished goods. COA and compliance documentation with every production run.

ISO 9001 · ISO 14001 · BPA-free · REACH

High-Barrier Material Expertise

Nylon, foil laminate and high-barrier structures validated for medical device applications. In-house lamination and converting eliminates inter-factory handling risk.

PA/PE · PET/AL/PE · BOPA
07 — Related Markets

Adjacent healthcare & hygiene categories we serve.

Medical device manufacturers often supply adjacent healthcare and hygiene markets. Each has its own page with material recommendations and product specs.

08 — Frequently Asked

Questions medical packaging buyers ask before quote.

Medical device flexible packaging uses high-barrier structures — typically PA/PE (nylon/polyethylene), PET/AL/PE (foil laminate) or transparent BOPA/RCPP — that maintain sterile barrier integrity from manufacture to point of use. Format options include rollstock film for HFFS/VFFS lines and individual sachets. Tansox manufactures all of these in-house at the Quanzhou facility.

Tansox manufactures medical packaging using materials and structures designed to comply with ISO 11607 sterile barrier system requirements. Tansox's ISO 9001 and ISO 14001 certified management systems, issued by EACC, support in-process QC and traceability at the company level. For specific ISO 11607 validation documentation, confirm requirements with our sales team at the quotation stage.

The standard MOQ for custom-printed medical device flexible packaging is 10,000 units per SKU. For rollstock film, MOQ is reel-based — confirm with sales. Contact our team with your format, structure and quantity requirements for a full quotation.

Get a Quote

Ready to order custom flexible packaging?

Fill in the basics — you'll have a structure recommendation and an FOB quote within one business day.

Response within 24 hours — Mon–Fri, 9am–6pm CST
FOB Xiamen · FOB Quanzhou · EXW available
Free printed sample with your first order
Tansox Factory — Quanzhou, Fujian, China
FACTORY · QUANZHOU · CHINA
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