Eyewear Product Certification

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No Certification, No Sales. PEL’s Experts Work with You to Make Sure That All Necessary Certifications Are Awarded

Eyewear product certification is crucial for brands aiming to sell their products either domestically or globally. Our experts ensure that your products pass all necessary certifications.

EU Certification

PEL provides a comprehensive one-stop solution for your eyewear products entering the EU market successfully, which guarantees customers’ products complying with relevant harmonized standard requirements. Working with PEL to certify your eyewear allows you access to the market for a reasonable cost and with no hassle.

Product type Product Directives' Regulations Harmonized Standards
Sunglasses 89/686/EEC Personal Protective Equipment Directive (PPE Directive) EN ISO 12312-1
Safety spectacles 89/686/EEC Personal Protective Equipment Directive (PPE Directive) EN 166 : 2001
Ski googles 89/686/EEC Personal Protective Equipment Directive (PPE Directive) EN 174 : 2001
Optical frames 93/42/EEC Medical Devices Directive (MODD Directive) EN ISO 12870
Reading glasses 93/42/EEC Medical Devices Directive (MODD Directive) EN 14139
Opthalmic lenses 93/42/EEC Medical Devices Directive (MODD Directive) EN ISO 14889
Spectacle frames* REACH Annex 17 (Nickle release Directive) EN 12472 EN 16128

* spectacle frames (apply to metal frames/frames with metal parts, prolonged contact with skin)

USA FDA Certification

Eyewear products for general use, such as reading glasses, ophthalmic lenses and non-prescription sunglasses, are classified as medical devices Class I, that are regulated by U.S. Food and Drug Administration. PEL ensures that your eyewear becomes USA FDA certified and that you’re able to access the American market.

Impact Resistance Declaration

In accordance with 21 CFR 801.410, all eyewear products imported to the US market should be mounted impact-resistant lenses, requiring a test of a statistically significant sample from each production batch. All importers must provide an impact resistance declaration with FDA compliance requirements. FDA accepts the Acceptable Quality (AQL) of 6.5, General Inspection Level II.

FDA Registration Workflow

  1. Sign FDA registration contract with PEL
  2. Establish the company account in FDA and obtain Personal Identification Number (PIN) from FDA.
  3. Pay the official fee to FDA and obtain Payment Confirmation Number (PCN) from FDA.
  4. FDA agent and official representative are responsible for all communication and feedback with FDA, Owner Number is obtained.
  5. Completion of Registration, Registration Number posted in FDA official website.

Sampling Plan Form: ANSI/ASQC Standard Z1 .4-2003

Lot/Batch Size (pcs of lenses) Sampling Size (pcs of lenses) Ac/Re Lot/Batch Size (pcs of lenses) Sampling Size (pcs of lenses) Ac/Re
2 to 8 2 0/1 281 to 500 50 7/8
9 to 15 3 0/1 501 to 1200 80 10/11
16 to 25 5 1/2 1201 to 3200 125 14/15
25 to 50 8 1/2 3201 to 10,000 200 21/22
51 to 90 13 2/3 10,001 to 35,000 315 21/22
91 to 150 20 3/4 35,001 to 150,000 500 21/22
151 to 280 32 5/6 150,001 to 500,000 800 21/22

Benefits

  • Comply with global regulations
  • Assure safety
  • Guarantee your products are saleable
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Get Started with Eyewear Product Certification Here

Learn more about how PEL can help your company improve the quality of your eyewear production and prevent problems before they reach your suppliers.

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