Turkey Medical Device Registration Requirements

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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 the EU’s new Medical Device Regulation for all quality control and trading purposes. Turkey requires medical devices to bear the conformity … See more

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 …

Turkey Medical Device Registration - TITUBB Approval

https://arazygroup.com/medical-device-registration-turkey/

REGULATORY AUTHORITY: Medical device registration is handled by Turkish Medicines and Medical Devices Agency (TITCK) CLASSIFICATION: Medical …

Medical devices in Turkey: Regulatory requirements

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

The law requires that medical devices may only be sold in Turkey through sales centers authorized by the Turkish Department of Health. The requirements for these sales …

Turkey Medical Device Regulations | RegDesk

https://www.regdesk.co/resource-library/turkey/

Appoint Turkish Registrant to submit registration application. Submit translated EU Declaration of Conformity (DoC) and translated and notarized CE Certificate …

Turkey Published New Medical Device Regulation - Esin …

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

According to the Regulation, manufacturers must register all medical devices (except for on-demand devices) with EUDAMED prior to placing them on the …

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 …

Medical Device Registration in Turkey - omcmedical.com

https://omcmedical.com/medical-device-registration-in-turkey/

Registration Process. Determine the Device Classification. Appoint Turkish Registrant to submit registration application. Submit translated EU Declaration of Conformity …

Turkish Ministry of Health Labeling Requirements – HIBCC

https://www.hibcc.org/global-resources/turkish-labeling-requirements/

The Republic of Turkey now has specific guidelines which require imported medical devices to be identified using an approved format such as the HIBC. The HIBC data …

Turkey - Import Requirements and Documentation

https://www.trade.gov/country-commercial-guides/turkey-import-requirements-and-documentation

Some product groups, including vehicles, require a widespread network of maintenance facilities in each of Turkey’s seven geographic regions. For vehicles, the …

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