Do you have any certificates for your eyewear products?

2025,06,23

-Introduction to UKCA Certification: Ensuring Compliance in the UK Market

The UK Conformity Assessed (UKCA) mark serves as a critical indicator of product compliance, signifying that a manufactured item adheres to the rigorous safety, health, and environmental protection standards mandated for the United Kingdom market.

This essential certification mark applies to a comprehensive range of products distributed within Great Britain (England, Wales, and Scotland), encompassing various categories of goods, including but not limited to medical devices. Among these regulated products, optical medical devices such as spectacles must bear the UKCA mark to demonstrate their compliance with the applicable UK technical regulations.

-Introduction to CE Marking: A Gateway to the European Market

CE marking serves as an essential safety certification indicator for products intended for the European market, signifying compliance with the stringent requirements outlined in relevant EU directives. Among the numerous standards governing product safety, EN ISO 12312 and EN ISO 12870 stand out as particularly significant in the optical industry.

EN ISO 12312 specifically addresses the safety and performance requirements for eye and face protection, with particular emphasis on sunglasses and related eyewear products. In contrast, EN ISO 12870 focuses on establishing quality and safety standards for optical glasses, including presbyopia correction glasses, ensuring their suitability for everyday use.

-Introduction to FDA Compliance and ANSI Z87.1 Certification

Eyewear products destined for the United States market must comply with two critical regulatory requirements: FDA (U.S. Food and Drug Administration) registration and ANSI Z87.1 standard certification.

As medical devices classified under FDA's Class I category, various types of eyewear (including sunglasses, prescription glasses, and other vision correction products) are subject to mandatory FDA registration. This process ensures that the products are properly listed in the FDA's official medical device database.

The ANSI Z87.1 standard, established as the American National Standard for Occupational and Educational Personal Eye and Face Protection Devices, specifically addresses safety requirements for protective eyewear. This certification is particularly crucial for eyewear designed for occupational use, ensuring adequate protection against various workplace hazards.

Author:

Ms. Annie Liu

E-mail:

sales@mlmeyewear.com

Phone/WhatsApp:

+86 13829903822