Top Trusted Contact Lens ODM China Manufacturer & Exporter

Our dual production facilities operate under full ISO 13485:2016 Medical Device Quality Management certification. We hold European Union CE marking under the Medical Device Regulation (MDR 2017/745), and our Hunan Haipuming cleanroom manufacturing facility is an FDA-registered medical establishment (FEI 3015587162). Every production run undergoes automated optical power verification, water content analysis, bioburden testing, and autoclave cycle data-logging.

Because contact lenses are Class II/Class III medical devices globally, importer license holders must register technical files with local health authorities. We provide complete manufacturer dossiers, including ISO 13485 declarations of conformity, CE technical summaries, biological safety reports (ISO 10993 cytotoxicity, ocular irritation, systemic toxicity), leachability studies, 3-to-5-year stability test documentation, and validated sterilization reports.

For ready-to-ship catalog designs from our stock library, MOQs start from 50 to 100 pairs per diopter with dispatch in 7 to 10 business days. For customized OEM private-label runs—including unique lens designs, custom base curves, personalized blister foil printing, and multilingual retail outer cartons—standard MOQs run from 1,000 to 3,000 pairs per design across standard power distributions, with lead times of 25 to 35 business days.

We use a sandwich casting process where FDA-approved organic and inorganic pigments are cured between inner and outer hydrophilic polymer layers. The pigment layer never touches corneal surfaces or palpebral conjunctiva, preventing pigment leaching, mechanical abrasion, and uneven oxygen depletion. Every production lot also undergoes mechanical rub tests and chemical extraction testing before packaging release.

Yes. Beyond sterile blister and vial filling, our ODM program covers branding design, barcode generation, local compliance labeling, luxury outer cartons, flat-sheet labeling stickers, and acrylic anti-theft display units for optical stores and cosmetics counters. This end-to-end service allows brands to source retail-ready vision products directly from our factories.