June 2021: Turkey Regulatory Update

New Medical Device Regulations came into force

As per the update posted on Turkish Medicines and Medical Devices Agency (regulatory agency of Turkey) on 14 June 2021, the “Medical Device Regulation” and the “In vitro Diagnostic Medical Device Regulation”, were published in the Turkish Official Gazette.

  • The “Medical Device Regulation” prepared in full compliance with the “Regulation (EU) 2017/745 on Medical Devices”  was published in the Official Gazette on 02.06.2021 and entered into force in a way that is valid as of 26/05/2021.
  • The “In vitro Diagnostic Medical Devices Regulation” prepared in full compliance with the “Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices” was published in the Official Gazette on 02.06.2021 and will enter into force on 26/05/2022.

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