Turkey Medical Device Regulations

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New Medical Devices Regulation in Turkey (Detail)

https://www.gentemizerozer.com/insights/detail/121/new-medical-devices-regulation-in-turkey

Before placing a medical device (except for a customised medical device) on the market, the manufacturer must affix a Unique Device Identification (“UDI”) code created in accordance with the rules of an issuing body to the device and, where applicable, to …

Medical devices in Turkey: Regulatory requirements

https://www.johner-institute.com/articles/regulatory-affairs/medical-devices-turkey/

Turkey, an interesting market. With a population even larger than that of Germany, Turkey …

NEW MEDICAL DEVICE REGULATIONS - Titck

https://titck.gov.tr/storage/Archive/2021/contentFile/Ek-2.1%20Duyuru%20metni-eng_2e87c6cd-5d45-43d9-9a35-0a94ffee8547.pdf

The Medical Device Regulation fully implemented in the EU and in our country, simultaneously as of 26 May 2021. The In vitro Diagnostic Medical Device Regulation …

Turkey Published New Medical Device Regulation - Esin …

https://www.esin.av.tr/2021/06/14/turkey-published-new-medical-device-regulation/

The Regulation extends the scope of medical devices. Accordingly, devices such as contact lenses, liposuction equipment, products that are applied on the human …

New Turkish Medical Device Regulation Published and …

https://chambers.com/articles/new-turkish-medical-device-regulation-published-and-aligned-with-eu-regulations

The Regulation sets out the specific qualifications this person must possess. As for medical devices whose manufacturer is not a resident in Turkey or in an EU …

Medical Device Regulation Has Been Published | Turkey

https://iclg.com/briefing/16917-medical-device-regulation-has-been-published-turkey

Medical Device Regulation Has Been Published | Turkey. Medical Device Regulation (“Regulation”) has been published in the Official Gazette numbered 31499 on 2 …

Turkey Aligns its Medical Device Regulation with the EU …

https://www.lexology.com/library/detail.aspx?g=42919510-e447-4a61-8fbd-698c1fa0ca1e

The current Medical Device Regulation simply requires the Ministry of Health to ensure the local registration and evaluation of certain information pertaining to devices, …

Turkey - Medical Technologies and Health IT

https://www.trade.gov/country-commercial-guides/turkey-medical-technologies-and-health-it

Because of Turkey’s customs union agreement with the European Union, Turkey follows the EU’s medical device directives. In May 2021, Turkey made applicable …