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ARTICLE · 08 JUNE 2021

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New Turkish Medical Device Regulation Published And Aligned With EU Regulations

ELIG Gürkaynak Attorneys-at-Law
ELIG Gürkaynak Attorneys-at-Law
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ELIG Gürkaynak Attorneys-at-Law

ELIG Gürkaynak Attorneys-at-Law

ELIG Gürkaynak Attorneys-at-Law is an eminent, independent Turkish law firm based in Istanbul. The...

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Turkish Medicines and Medical Devices Agency ("Agency") is noted as the competent authority to enforce the Regulation.

TurkeyAntitrust/Competition Law
Gönenç Gürkaynak
Gönenç Gürkaynak
Ceren Yıldız
Ceren Yıldız
Nazlı Gürün
Nazlı Gürün
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Turkish Ministry of Health's preparations of the draft Medical Device Regulation ("Draft Regulation") which was announced on October 4, 20181 has come to an end and the finalized Medical Device Regulation ("Regulation")2 has been published in the Official Gazette on June 2, 2021. The Regulation has similar content to that of the Draft Regulation, and it re-designs the rules pertaining to placement of medical devices in market, having been prepared in a manner to be fully in line with Regulation (EU) 2017/745 of the European Parliament which also has come into force recently. Along with the Regulation, "In Vitro Diagnostic Regulation" and "Communiqué on Annulment of Communiqué on Notified Bodies to Operate in Medical Device Sector" have also been published in the Official Gazette on the same day. Turkish Medicines and Medical Devices Agency ("Agency") is noted as the competent authority to enforce the Regulation.

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