Today, the healthcare sector has a rapidly changing structure on a global scale. Advancing technology, increasing healthcare needs, and tightening regulations force all institutions operating in this sector to think more flexibly, more responsively, and more holistically. One of the clearest reflections of this change is observed in the structures of medical product representation.
Launching a medical product to the market is no longer limited to import or sales processes. Ensuring that the product is safe for clinical use, fully compliant with legal regulations, aligned with the needs of healthcare professionals, and prioritizes patient safety has become one of the primary responsibilities of the representative company.
In this context, the traditional “product-oriented” distributorship model is being replaced by a more holistic approach — the “system-oriented representation structure.”
The classical representation model was shaped around procuring a product from abroad, completing its legal registration, and introducing it to the market. However, current needs show that this model is no longer sustainable. Especially for products intended for clinical use, it has become essential to draw a comprehensive framework covering technical, regulatory, and user experience aspects.
New-generation representation structures manage the process not only as a logistical operation but as a strategic whole. Within this structure:
Clinical adaptation process: Guidance and training are provided to ensure correct and effective use of the product by healthcare professionals.
Regulation management: Legal requirements such as CE marking, ISO 13485 compliance, and the Turkish Product Tracking System (ÜTS) are carried out completely and up to date.
User feedback: Feedback from clinical fields is systematically conveyed to the manufacturer, contributing to product quality improvement.
Field strategy: Product distribution, user support, and after-sales services are planned in an integrated manner from a single center.
Sources:
ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes
TİTCK – Medical Devices Product Tracking System Compliance Guide, 2024
This integrated representation approach has been in place for many years in many European countries and the United States. In Turkey, this model has been increasingly adopted in recent years, particularly with the tightening of regulatory authorities (TİTCK) and quality standards (ISO, CE).
VARKOM Healthcare stands out as one of the exemplary corporate structures in Turkey that addresses this transformation process with a holistic perspective. Established in 2025 by Bedir Group, VARKOM Healthcare positions itself not just as a supplier or sales company, but as a structure capable of building and sustainably managing systems in healthcare.
The corporate foundations of this new-generation representation approach are based on the group’s previous experiences. KAR-OK Industrial and Medical Gases, operating under Bedir Group for many years, has built a reliable field structure through successful gas distribution and infrastructure projects in the Eastern Anatolia Region.
This experience is now being transferred to medical product representation under the VARKOM umbrella. The group has strong infrastructure in public procurement, regulatory processes, supply chain development, and managing communication between the field and the manufacturer. Thus, VARKOM is gaining the identity of not only a commercial representative but also a strategic solution partner that understands, manages, and develops the entire system.
Regulatory compliance forms the foundation of safety in medical products. The Product Tracking System (ÜTS), managed by TİTCK, makes it mandatory for every product to be registered, traceable, and compliant with regulations. Additionally, CE marking, ISO 13485 quality management, and technical file responsibility are among the legal obligations companies must fulfill.
New-generation representation structures are responsible not only for obtaining these certificates but also for managing the entire process with internal audits. This creates a sustainable environment of trust for manufacturers, users, and public authorities alike.
Sources:
WHO – Health System Responsiveness: WHO Frameworks and Guidelines, 2020
TİTCK – Regulation on Sales, Advertising, and Promotion Activities of Medical Devices, 2023
European Commission – Medical Devices Regulation (MDR 2017/745)
In the medical sector, success is no longer achieved solely through product variety or price advantage; it is possible through reliable processes, regulatory compliance, training support, and a transparent representation model. Structures that adopt this approach not only meet today’s needs but also have the potential to shape the future of the sector.
VARKOM Healthcare, acting with this vision, aims not only for commercial success but also for building structural trust, thereby establishing the future of medical representation in Turkey today.
This content is prepared solely for informational and corporate promotional purposes. It does not contain any medical advice, individual guidance, or product-based commercial promotion. The institutional names mentioned are used within the framework of publicly available information in the context of sectoral analysis.
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