Mylensora Technology Co.,Ltd designs, manufactures, and packages high-precision contact lenses strictly aligned with international medical device regulations, ensuring seamless regulatory clearance and market access for global distributors and brand owners.
Conformité Européenne Certified under European Union health, safety, and environmental protection directives. Our CE certification allows overseas distributors and retailers to import and commercialize cosmetic and optical lenses legally across EEA member states.
ISO 13485 Validates that our manufacturing facility adheres to comprehensive quality management standards specialized for ophthalmic medical devices, covering risk analysis, raw material traceability, cleanroom controls, and validation.
NMPA (CFDA) Our facility holds Class III Medical Device Manufacturing and Product Registration approval, representing the most stringent safety, sterile processing, automated cast-molding, and full-cycle traceability controls in the industry.
Every single contact lens leaving our facility complies with strict dimensional, optical, and microbiological safety benchmarks verified through calibrated automated instruments.
Molding, pigment sandwich encapsulation, and hydration take place in positive-pressure cleanroom environments with HEPA air filtration.
Complies with ISO 10993 cytotoxicity, ocular irritation, and sensitization standards, guaranteeing complete safety for the cornea and tear film.
Automated visual inspection checks base curve, optical diameter, center thickness, and edge profile tolerances under high-resolution optics.
Autoclave steam sterilization processes validated per ISO 11134 and ISO 17665, delivering a Sterility Assurance Level (SAL) of 10^-6.
We provide full technical documentation and registration files to accelerate import licensing and local health authority approvals in your destination country.
| Document / File | Standard / Authority | Scope & Coverage | Buyer Utilization |
|---|---|---|---|
| ISO 13485:2016 Certificate | International Medical Standards | Design, Molding, Packaging of Soft Contact Lenses | Supplier compliance validation and health ministry filing |
| CE Conformity Certificate | European Medical Device Directive | Cosmetic & Prescription Contact Lens Lines | Customs clearance in Europe & CE-recognizing territories |
| Medical Device Production License | NMPA (National Medical Products Administration) | Class III Contact Lens Manufacturing & Quality Systems | Official verification of authentic direct-factory origin |
| Certificate of Free Sale (CFS) | Authorized Competent Authority | Commercial distribution authorization for export models | Required for import permits across Southeast Asia, MEA & LATAM |
| Biological Evaluation Reports | ISO 10993 Series (Cytotoxicity & Irritation) | Biocompatibility of hydrogel & color pigment layers | Mandatory compliance verification for branded retail safety |
| Sterility & Stability Records | ISO 11137 / ISO 17665 & Accelerated Aging | Blister pack integrity, 5-year shelf-life stability data | Ensures shelf stability and expiration claims for private label brands |
Key information for procurement teams, distributors, and private label brand partners evaluating Mylensora Technology Co.,Ltd.
Contact our regulatory affairs and wholesale team today to receive certified copies of our ISO 13485, CE certificates, batch inspection documentation, and OEM sample kits.
