Fresh Lenses
Fresh Lenses
Specially curated medical-grade lenses calibrated for compliance with the Ministry of Health, Labour and Welfare (MHLW) optical criteria.
Japan represents one of the most sophisticated contact lens markets globally, characterized by high consumer expectations for comfort, visual acuity, ocular safety, and regulatory compliance. Under the Pharmaceutical and Medical Devices Act (PMD Act), contact lenses (both corrective and cosmetic non-corrective) are categorized as Highly Controlled Medical Devices (Class III). To enter this lucrative yet strictly regulated landscape, global brands, distributors, and retailers require a reliable manufacturing partner with deep expertise in Foreign Manufacturer Registration (FMR) and PMDA compliant quality management systems.
Shenzhen Fresh Vision Co., Ltd., as an established OEM/ODM leader with a decade of global export credentials, delivers high-standard manufacturing services that align with these demanding metrics. With advanced polymers, biocompatible hydrogel formulations, and dynamic precision molding technologies, we offer complete OEM solutions custom-engineered to meet the strict quality standards required to secure marketing authorization in Japan.
"To succeed in Japan's contact lens ecosystem, manufacturers must not only offer beautiful cosmetic designs but also guarantee structural parameters like precise base curves (BC), oxygen transmissibility (Dk/t), and zero chemical toxicity in pigments."
Traceability and standard operating procedures (SOPs) on all lines, fulfilling international medical device ISO 13485 standards.
We build optical products incorporating the latest materials science trends, keeping your brand ahead of competitive updates in East Asia.
Traditional HEMA lenses have limitative oxygen transmissibility. Our R&D team (led by 5 dedicated polymer engineers, including 3 master's degree graduates) has developed a new silicone hydrogel formulation with improved oxygen permeability (Dk/t value exceeding 80). By using long-chain fluorosilicone macromonomers, we prevent lipid deposition and dry-eye symptoms, which are top criteria for Japanese consumers prioritizing eye health.
By employing high-definition optical molds and state-of-the-art demoulding machines, our manufacturing error rate is controlled to less than 1.5 microns. The edge profile of each lens is engineered with a smooth, rounded edge design to minimize friction against the palpebral conjunctiva, promoting all-day comfort without irritation.
In the cosmetic and colored contact lens market (particularly Tokyo's Harajuku and Akihabara subculture trends), bright, layered colors are in high demand. However, pigments must never come into contact with the cornea. Fresh Vision implements a dual-sided sandwich encapsulation technology, embedding the dye layer completely inside the polymer matrix. This guarantees zero dye leakage, satisfying MHLW's biological safety tests.
| Material Class | Water Content | Oxygen Permeability (Dk/t) | Wear Modality | Primary Target Audience |
|---|---|---|---|---|
| Hydrogel (HEMA-based) | 38% - 42% | 15 - 25 | Daily / Monthly | Cosplay, Costume & Color Fashion Brands |
| Advanced Hydrogel | 55% - 58% | 28 - 35 | Daily (1-Day) | General E-commerce, Retail Drugstores |
| Silicone Hydrogel (Si-Hy) | 45% - 48% | 80 - 120 | Daily / Monthly | Optometry Clinics, Premium Cosmetic Brands |
We employ state-of-the-art laboratory testing systems to measure all physical parameters of contact lenses prior to international dispatch.
Managing an international medical device supply chain requires efficient logistics and strong local support. We facilitate smooth operations for Japanese buyers by offering:
Discover our full product range suitable for cosmetic and optical applications, complete with high-durability polymers and diverse diameters.
Key answers for strategic procurement coordinators, brand owners, and compliance heads managing medical imports into Japan.
To market contacts in Japan, you must obtain a Marketing Authorization Holder (MAH) license or partner with an authorized dMAH. The manufacturing plant must undergo Foreign Manufacturer Registration (FMR) with the PMDA, verifying conformance to QMS Ministerial Ordinance No. 169. Shenzhen Fresh Vision assists partners with necessary technical files, ISO 13485 documentation, and product safety datasheets to support these submissions.
We use proprietary sandwich construction methodology. The color pigments are fully sealed between layers of biocompatible polymers (such as Hydrogel or Silicone Hydrogel). The outer surfaces consist of pigment-free hydrogel, ensuring the eye is protected from chemical exposure and irritation.
For initial custom OEM orders requiring packaging localization (carton, blister sealing foil design), the process takes approximately 35 to 45 days. This includes packaging print proofs, biological validation, and sterilization cycle confirmations. Repeat orders are fulfilled within 25 to 30 days.
Yes, all materials (including HEMA monomers, hydration saline, and packaging plastic) are sourced from medical-grade suppliers. We provide full certificate of analysis (COA) batches and trace chemical tracking from monomer polymerization down to the sealed blister unit.
Get in touch with our regulatory compliance team and product design engineers to request a sample pack and review technical certifications.
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