CE Class I
Medical Polymer · PPSU
Standardized B2B prescription eyewear engineered for high durability, hypoallergenic skin contact, and precision optometric glazing in tropical urban environments.
CE Class I
CE Certified
EN ISO 12870
CE Class I
CE Certified
ISO Compliant
CE Class I
MDR Standard
Navigating medical device import regulations, customs validation at Cát Lái Port, and consumer safety standards in Vietnam’s optical trade ecosystem.
Optical trade spectacle frames designed for corrective ophthalmic lenses qualify as Class I non-invasive medical devices under European Medical Device Regulation (MDR 2017/745). Complete Technical Construction Files (TCF), Declaration of Conformity (DoC), and Authorized Representative agreements safeguard Vietnamese distributors against cross-border customs impoundment.
Specimen testing verifies mechanical stability under cyclical endurance: 500 temple opening/closing cycles without hinge loosening, bridge deformation resistance under 5.0 N frontal load, and dimensional tolerance of lens bevel grooves (±0.15mm) to eliminate optical center displacement and frame distortion during automatic edger glazing.
Under the Vietnamese Ministry of Health (MoH) regulations governed by Decree 98/2021/ND-CP, corrective optical frames require Class A medical device declaration dossiers. Having factory CE documentation, ISO 13485:2016 factory audit trails, and Certificate of Free Sale (CFS) accelerates Vietnamese customs clearance at Cát Lái and Tân Sơn Nhất ports.
| Testing Parameter | Harmonized International Protocol | Material Acceptance Threshold | Significance for Ho Chi Minh City Optical Buyers |
|---|---|---|---|
| Nickel Release Rate | EN 1811:2011 + A1:2015 / EN 16128 | < 0.5 μg/cm²/week direct prolonged contact | Prevents contact dermatitis and allergic rashes in HCMC’s high-perspiration tropical climate. |
| Perspiration Resistance | ISO 12870 Section 4.7 (Synthetic Sweat) | pH 4.7 buffered lactate solution, 24h at 35°C | Guarantees galvanic plating and PVD coatings do not bubble or green under monsoonal humidity. |
| Thermal Stability | ISO 12870 Section 4.8 Thermal Deformation | Dimensional shift < 1.5% after 60°C exposure | Avoids lens popping and frame warping when eyewear is left in parked motorbikes or outdoor stalls. |
| Flammability Resistance | EN ISO 11978 / ISO 12870 4.6 | No continued combustion after glowing rod test | Crucial for hospital optical shop procurement and corporate optical chain compliance dossiers. |
Unified account access to our high-fashion, vintage heritage, and technical performance product tiers—spanning artisanal acetates, ultralight screwless 3D-printed frames, and flexible everyday trade chassis.
In-house tooling workshops operate high-precision 5-axis CNC cutters to produce custom hinge seats, internal wire cores, and pad arm geometries optimized for Southeast Asian facial ergonomics.
Turnkey OEM/ODM capabilities for optical chains in Vietnam. From laser temple engraving and custom pad printing to localized presentation packaging and CE compliance technical files.
We provide curated frame boards, boutique display fixtures, and organized trunk shows directly to optometric practices, ensuring retail teams can present our collections with clinical authority.
How our frame engineering directly solves the micro-climatic and craniofacial requirements of consumers in southern Vietnam.
Standard European optical chassis often cause slipping, temporal pinching, and lash collision when fitted to Asian cranial profiles. Our specialized export lines for the Vietnamese market integrate a modified 3-point facial fit:
Ho Chi Minh City experiences average year-round humidity exceeding 78% and surface temperatures surpassing 38°C. Commuting by motorbike in traffic congestion exposes frames to a harsh cocktail of carbon exhaust, airborne road particulates, UV radiation, and acidic sebum secretions.
Under conventional manufacturing, cheap cellulose propionate or low-grade metal frames degrade rapidly: lacquer peels, acetate whitens, and unplated screws seize. Our trade frames counteract this through:
Strategic insights into retail transformation, clinical optometry upgrades, and evolving consumer buying behavior across Saigon's optical districts.
Over 50% of school-age children in urban centers like District 1, District 7, and Bình Thạnh suffer from myopia. There is an explosive wholesale demand for durable, shatterproof TR90 and medical-grade PPSU frames capable of accommodating high negative diopter lenses and specialized myopia-control peripheral defocus lenses without excessive thickness.
Traditional wholesale hubs around District 5 (Trần Hưng Đạo, Hải Thượng Lãn Ông) are transitioning toward specialized optometry chains and medical eye hospital dispensaries (e.g., HCMC Eye Hospital on Bà Huyện Thanh Quan). Institutional buyers now mandate authenticated CE dossiers, verifiable batch traceability, and formal tax invoicing (VAT red invoices).
Tech workers in Saigon Hi-Tech Park and multinational corporate hubs in District 1 demand frames under 12 grams. Pure Japanese beta-titanium and bio-based acetates derived from sustainable wood pulp and cotton lint are replacing heavy alloy plastics, driven by consumer demand for all-day comfort during prolonged digital screen use.
Clear operational guidelines on customs clearance, product testing protocols, minimum order thresholds, and private labeling.
Every commercial optical export shipment is accompanied by a full customs compliance binder: (1) Commercial Invoice and Packing List specifying exact HS Codes (HS 9003.11 for plastic/acetate frames, HS 9003.19 for metal/titanium frames); (2) Certificate of Origin (Form E or Form AJ/VJ for tariff optimization); (3) Factory Declaration of Conformity to EU MDR 2017/745 Class I; (4) ISO 13485:2016 and ISO 9001:2015 certified quality audit records; and (5) Certificate of Free Sale (CFS). These credentials enable Vietnamese importers to directly submit their Class A medical device notification on the Ministry of Health public portal.
All export frames comply with ISO 12870 synthetic perspiration stress testing. Metal components undergo multi-stage ultrasonic degreasing followed by physical vapor deposition (PVD) vacuum ion plating, sealed with an electrophoretic passivation clear coat. This prevents green copper corrosion, galvanic blistering, and peeling when exposed to human sweat (pH 4.7) and road pollution during motorbike commutes. Acetate models are aged through controlled dehumidification to ensure zero plasticizer leaching or cloudy white oxidation over multi-year retail display cycles.
For ready-stock models across our core acetate, metal, and TR90 catalog, we accommodate boutique optical clinics and multi-store chains with a flexible low-tier MOQ of just 12 pieces per model (mixed colorways permitted). For fully customized OEM/ODM projects—including custom pantone acetate lamination, laser brand identification on temple cores, and bespoke packaging—the MOQ is 300 pieces per model (100 pieces per SKU colorway).
For urgent replenishment orders, our bonded warehouse utilizes DHL/FedEx Express cargo into Tân Sơn Nhất International Airport (SGN) with an average door-to-door transit time of 3 to 5 business days. For volume bulk container shipments, ocean cargo departing from our coastal export hubs berths at Cát Lái Port or SP-PSA International Terminal within 7 to 10 sailing days, offering substantial cost efficiencies for large optical distributors.
Yes. We provide sample trunk kits curated for optometry practices and dispensary owners in Ho Chi Minh City. You can evaluate hinge torque, bevel depth, raw material elasticity, and aesthetic color fidelity firsthand. Sample costs are fully credited back toward your commercial opening inventory invoice upon contract finalization.
We maintain an active component reserve for all active model collections for a minimum of 36 months following production cessation. We provide matching front screws, silicone pad arms, spring hinge mechanisms, and replacement acetate temple tips in organized repair assortments, ensuring your bench opticians can deliver fast post-sale adjustments to patients without rendering frames obsolete.
Partner with a five-generation optical manufacturer. Access compliant CE Class I optical trade frames, low factory-direct MOQs, complete Decree 98 regulatory documentation, and dependable Cát Lái customs support.