Medical device

Medical Devices Portfolio Overview

Eye medical devices can include diagnostic, surgical and patient-care products. Farmak International’s current portfolio in this category focuses on substance-based ophthalmic eye drops. Eye drops may be categorized as substance-based medical devices when they achieve their intended effect primarily through physical action, such as lubricating and hydrating the ocular surface or forming a protective moisture film, rather than through a primarily pharmacological mechanism. They may act physically by lubricating the ocular surface, maintaining moisture and helping reduce manifestations of dry eye, according to their intended purpose. Substance-based medical devices are subject to applicable risk classification, technical documentation, clinical evaluation, conformity assessment and post-market requirements.

At Farmak International, we produce and supply substance-based medical devices that comply with detailed technical documentation standards. The section includes:

Typically, a medical device for the eye may be intended for people experiencing dry-eye manifestations or requiring ophthalmic lubrication and ocular-surface care. Additional uses should follow the applicable instructions for use.

Clinical Settings & Use Cases

A medical eye device in the form of drops may act physically by lubricating the ocular surface, reducing friction, removing minor irritations, and creating a moisture barrier. Such products may be used in home and clinical settings, depending on their intended purpose, instructions for use, and local availability. As well as eye medical equipment, these substance-based medical devices are in high demand in ophthalmology clinics, hospitals, and multidisciplinary medical facilities.

We distribute our eye care medical devices through B2B channels, to authorised distributors, hospitals, ophthalmology clinics and pharmacy-sector partners, subject to local regulatory and distribution requirements.

Technical Specifications & Device Configurations

Ophthalmic medical devices must meet the applicable microbiological quality requirements. Where a product is supplied sterile, its sterility must be established and maintained through validated manufacturing and packaging processes. We offer eye drops in 10 ml containers. Where designed for multidose use, the applicable period and conditions of use are stated in the product instructions. The packaging and delivery system are designed to maintain product integrity and provide consistent drop delivery in accordance with the validated device specifications. Different eye-drop formulations contain different concentrations and combinations of constituent substances.

The relevant technical documentation includes applicable compatibility, stability, performance and risk-management information supporting the product throughout its stated shelf life. Also, as an ophthalmic medical devices distributor, we provide the applicable technical and performance documentation for the eye-care devices in our portfolio.

Quality Assurance & Regulatory Compliance

For an eye care treatment device supplier, ISO 13485 provides an internationally recognised framework for a medical-device quality management system and supports compliance with applicable regulatory requirements. This internationally recognised standard specifies quality-management-system requirements for organisations involved in the design, manufacture and related lifecycle activities of medical devices.

Our eye treatment products are developed and manufactured within Farmak’s ISO 13485-certified quality management system and are subject to documented risk-management processes. Applicable sterilisation and packaging processes are validated and controlled within the quality management system and according to the relevant technical requirements. In addition, we qualify suppliers of raw materials and packaging materials and maintain traceability through the relevant stages of the controlled supply chain. Final products manufactured by Farmak Group undergo applicable quality-control testing in Farmak laboratories. Product performance and regulatory conformity are supported by technical documentation, risk management and the relevant clinical or performance evaluation.

Partnership with Farmak International for Medical Eye and Ear Devices Supply

When a medical institution requires eye health devices, its supplier should provide reliable service, appropriate documentation, and consistent quality. Since our foundation, we have proven to be a strong global partner, delivering our products to over 60 countries. Due to flexible distribution models, we ensure consistent product availability and smooth supplies upon customers’ requests.

We offer high-quality eye care devices for hospitals and other institutional partners. Product specifications are based on the available portfolio, while pricing and volume-based terms for wholesale supply and tenders are agreed according to order volumes, market requirements, and commercial arrangements. We help our partners obtain export licenses and prepare tender documentation and regulatory dossiers to market our medical devices.