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FDAnews Device Daily Bulletin

Turkish Regulator Publishes Draft Rules on Device Monitoring, Registration

July 6, 2017

The Turkish Medicines and Medical Devices Agency has published a draft regulation aimed at tracking medical devices.

Under the regulation, all companies and individuals involved in device manufacturing, import/export, sale, maintenance, distribution or repair must register with the agency and anyone subject to the requirements must obtain an electronic signature, and submit specified information and documents.

The draft regulation would also require a declaration of conformity, labeling and a user manual, to be submitted to the agency.

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