Consultation on New Draft Regulation on Promotion of Medical Devices

Dicle Doğan and Fatma Sevde Tan, Gun + Partners

On 28 January 2020, the Turkish Medicines and Medical Devices Agency published a draft Regulation on the Sale, Advertisement and Promotion of Medical Devices (Turkish language) which will amend some of the existing provisions of the regulatory framework and introduce new rules.

The most significant amendments are related to restrictions of medical device sales and advertising activities. The medical devices described in either of the two categories below can now be placed on the market via the internet by addressing the recipients as opposed to the end consumers:

  • Medical devices that are sold, adapted or applied in prosthesis and orthotic centres, opticianry or dental prosthesis laboratories.
  • Medical devices intended to be exclusively used or applied by healthcare professionals.

In terms of advertising, those medical devices shall not be advertised directly or indirectly addressing the end consumer via any media. Medical devices falling outside of the scope of these two categories can be advertised to the general public only via the internet, with the exception of medical devices listed in Annex 3 of the draft Regulation, which includes devices such as dentifrices, condoms, cotton and so on, which can be still advertised through all media.

The draft Regulation was open for public consultation until 3 February 2020. Industry stakeholders have submitted their opinions and suggestions.

First published by Practical Law, in 29.02.2020

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