Consultation on draft Regulation on Sales, Advertisement and Promotion of Medical Devices


Dicle Doğan and Fatma Sevde Tan, Gun + Partners

On 9 May 2019, the Turkish Medicines and Medical Devices Agency published the draft Regulation on Sales, Advertisement and Promotion of Medical Devices (Turkish language) due to the emergence of current needs and problems while exercising the existing regulation. The draft preserves many provisions of the regulation in effect, but also introduces new provisions and amendments.

One of the significant changes proposed by the draft Regulation is the prohibition of the direct and distance sale of some devices to consumers. Devices sold or applied in hearing aid centres, custom-made prosthetics and orthosis centres, and optician facilities, as well as medical devices intended to be used exclusively by healthcare professionals, shall not be placed on the consumer market or advertised directly or indirectly to the public.

In relation to the notifications made regarding the sponsorship of healthcare professionals, only certified personnel shall make the required notifications. Such personnel shall receive his/her certification from the local health authority. 

The draft Regulation is currently open for public consultation until 9 June 2019.

First published by Practical Law, 01.06.2019