Our commitment to quality

Our commitment to quality

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, who will maintain a strong commitment to quality, and dedication to comply with international manufacturing standards.

Comprehensive accreditation processes

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.

EC CERTIFICATE
ISO 13485:2016 CERTIFICATE

EC Certificate – Production Quality Assurance (CE Marked Product)

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

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

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

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

Be confident with Gelflex

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 every time.