Recently, the Turkish Medicine and Medical Devices Authority (“TITCK”) made amendments to the Regulation on sales, advertising and promotion of Medical Devices.
of Medical Devices
What are the main changes?
Sales centres authorised by the Regulatory Agency to sell their Medical Devices in Turkey, must not only send data on their sales to the Product Tracking System, but also store this information.
With regard to advertising, Medical Devices have been divided into three categories:
- Medical Devices that cannot be advertised to the general public, such as devices sold or adapted solely in prosthesis laboratories and hearing aid centres and products used or applied exclusively by healthcare professionals.
- Medical Devices that can be advertised directly to the consumer, such as cotton wool, adhesive bandages and mouthwash.
- Medical Devices that do not fall into the previous categories, such as products that can only be advertised through the platform in which they are sold. These products cannot be promoted in any other platform.
If their advertisement does not conform to the relevant requirements, the sales centres will be warned and if they do not remedy the breach within 3 days following the Agency’s warning, their activities will be suspended for 15 days. If during the temporary suspension the centres will carry on its normal activity, their authorization certificate can be cancelled.
In accordance with the measurements undertaken to face Covid-19 Emergency, the Turkish Ministry of Health has authority to make exceptions for sales centres whose function is that of protection of public health in case of epidemics, pandemics and other situations.
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