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Did you know contact lenses are classified as medical devices? That’s why it is important to choose a partner or a lens manufacturer, who will maintain a strong commitment to quality, and dedication to comply with international manufacturing standards.

Gelflex is certified through comprehensive accreditation processes, which are undertaken by third party governing bodies. These accreditations involve a thorough review of the entire manufacturing process. Our comprehensive Quality Management System ensures that every step in the manufacture of our contact lenses contributes to producing a safe, effective and comfortable product for our customers. 


Our certifications include:

  • EC Certificate - Production Quality Assurance (CE Marked Product)

  • ISO 13485:2016/EN ISO 13485:2016 Management System Certificate 

  • Listed Medical Devices on the Australian Register of Therapeutic Goods (ARTG) database – TGA Australia

  • Registered foreign manufacturer of contact lenses with US Food and Drug Administration (FDA) - USA


We also have regulatory approval to sell our contact lenses in over 40 different countries around the world.


Be confident with Gelflex.

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