In May, 2019, the Agency had announced the Draft Regulation on Sales, Advertising and Promotion of Medical Devices, expected to replace the Regulation on Sales, Advertising and Promotion of Medical Devices (“Regulation”), by expressing that the Regulation required an amendment as a result of practical matters presented during the implementation of the Regulation and the current needs of the sector. The draft regulation was not enacted to this date, and instead, on January 28, 2020, the Agency announced the Draft Amendment Regulation on Sales, Advertising and Promotion of Medical Devices (“Amendment Regulation”)1 which will amend the Regulation itself. The Agency has invited comments from concerned parties until February 3, 2020.
The Amendment Regulation introduces amendments to the notification periods and consequences relating to replacements of managing directors and sales persons in medical device sales centers. With regard to advertising of medical devices, the Amendment Regulation provides that, medical devices that are outside of the scope of devices that are (i) being sold at hearing aid, tailored prosthesis and orthosis centers or optician or dental prosthesis laboratories, (ii) to be used or applied by healthcare personnel, or to be applied at sales centers, and (iii) set forth under Annex-3 of the Regulation, can only be advertised through the internet. The Regulation in its current form allows these medical devices to be advertised in any platform. In parallel with this, the Amendment Regulation foresees that the sales center will be warned in the event their advertisement does not conform to the relevant requirements, and activities of the sales center will be suspended for 15 days in the event it does not remedy the breach within 3 days following the Agency’s warning. In addition, the Amendment Regulation suggests that the Ministry of Trade will be notified on unlawful advertisements directed towards consumers.
The Amendment Regulation further amends (i) cancellation procedure pertaining to sales centers’ licenses and (ii) Annex-2 of the Regulation providing the Ministry’s audit form for sales centers.
The publication and the enforcement date of the Amendment Regulation are yet to be announced. However considering the small window of time between the announcement date and last date for suggestions, we might expect that the Amendment Regulation will be published in the upcoming months.
1 Please see https://www.titck.gov.tr/duyuru/tibbi-cihaz-satis-reklam-ve-tanitim-yonetmelikte-degisiklik-yapilmasina-dair-yonetmelik-taslagi-28012020110825 for the announcement in Turkish
By Gonenc Gurkaynak, Partner, Ceren Yildiz, Partner, Noyan Utkan, Associate, and Nazli Gurun, Associate, ELIG Gürkaynak Attorneys-at-Law