"By-Law Amending the Regulation on Sales, Advertisement and Promotion of Medical Devices" ("By-Law") has been published in the Official Gazette dated 02.09.2020 in which significant amendments has been made regarding the advertisement of medical devices and their sales on the internet.
According to articles 8 and 9 of the By-Law, advertisement and online sale of medical devices listed below are prohibited:
- Devices that are sold, adapted or applied in hearing aid centers, custom-made prosthesis and orthosis centers or optician institutions or dental prosthesis laboratories,
- Devices that are intended to be used or applied exclusively by healthcare professionals or that require application in medical device sales points.
The advertisement of the devices listed under Annex-3 of the By-Law is not restricted and certificate of authorization shall not be required for the online sales of the listed devices.
In addition, except for the devices listed under Annex-3, sale of the devices other than those specified in subparagraphs (a) and (b) above shall only be made by authorized sales points; and, advertisement can only be made on the online portal where the sale is made.
In the event that the advertisements or online sales are not made in compliance with relevant legislations, relevant sales point shall be warned and if the requirements of such notification is not met within 3 (three) business days as of the date of the notification, the sales activities of that point shall be suspended for 15 days.
Along with the amendments implemented regarding the advertisement and online sales of medical devices, important to note that the sale of the devices -which should be used or applied exclusively by healthcare professionals- shall not be sold in pharmacies, except for the devices specified in Article 13 of the Regulation.
The content herein is aimed at providing a general insight regarding the subject. For customized circumstances or further information, please refer to your lawyer. Amendment On The By-Law On Sales, Advertisement And Promotion Of Medical Devices
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