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Regulatory Update: Turkey

A Guideline for the Withdrawal and Recall of Medical Devices and In Vitro Diagnostic Devices from the Market was published on February 24, 2023, and a first revision was issued on July 19, 2023.

The primary goal of this Guideline is to establish a proactive framework aimed at preventing the inclusion of unsafe or inappropriate medical devices in the market. It not only sets out clear procedures but also delineates the responsibilities of the relevant stakeholders in ensuring compliance with rigorous safety standards.

Moreover, the Guideline provides a transparent and systematic approach for the withdrawal and recall of non-conforming products from the market. This process is activated when such products are identified through the existing market surveillance and warning system. By doing so, the regulatory body demonstrates a resolute dedication to maintaining the highest standards of safety and efficacy in the healthcare industry.

This Guideline serves as a cornerstone in bolstering consumer confidence and further establishes the regulatory framework for medical devices. It stands as a testament to the unwavering commitment of regulatory authorities to protect public health and ensure the availability of safe and effective medical technologies.

For the full resource, visit HERE. There are Turkish and English translations available. 

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