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QUALITY

Did you know contact lenses are classified as medical devices? That’s why it is important to choose a partner or a lens manufacturer, which 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 audits 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:

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  • CE Marking (EN ISO 13485:2016 – Medical Devices Quality Management & EN ISO 14971:2012 – Medical Devices – Application of risk management to medical devices) – European Union (EU)

  • 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 30 different countries around the world.

 

Be confident with Gelflex.