Check the lens before it reaches your eye.

MFDS is South Korea’s Ministry of Food and Drug Safety; KFDA is the former agency name. Product authorization and Korean good-manufacturing-practice (KGMP) requirements are separate checks. Match each record to the exact device or covered family, manufacturer, manufacturing site, scope, status and validity. Korean origin, a factory certificate or a generic badge does not establish authorization for every lens or destination.

ISO 13485:2016 is the current published quality-management-system standard for medical devices; it was reviewed and confirmed in 2025. Certification concerns the named organization, site and scope, not approval of every product. The ISO 18369 series addresses contact-lens terminology, tolerances and test methods. As of October 1, 2026, ISO 18369-1:2017 remains the published Part 1; ISO/FDIS 18369-1 is a final draft, not a published replacement. Check the applicable part and edition in any technical record.

In the United States, colored and decorative contact lenses are medical devices that require a valid contact lens prescription, including 0.00-power lenses. Under the FTC Contact Lens Rule, a seller must obtain a prescription copy or complete the required verification process before filling an order. Use the exact prescribed brand or model and parameters; a matching power alone is not enough.

FDA establishment registration and device listing do not mean that a device is cleared or approved. FDA does not issue registration certificates for medical-device facilities. Product-specific clearance and approval are separate regulatory routes; check the record for the exact device and manufacturer instead of treating “FDA registered” as a product-safety guarantee.

CE marking must be interpreted for the specific product and applicable EU framework. Certain products without an intended medical purpose are addressed by MDR Annex XVI rules. A CE mark should not be generalized across unrelated models or markets.

Import, prescription, sale and labeling requirements differ by destination. Match any official record to the exact device or covered family, legal manufacturer, manufacturing site where relevant, intended use, local importer or responsible party where required, and current status, scope and validity. Authorization in one country does not establish authorization in another. Customs clearance does not prove product authorization or individual suitability.