Turkey Medical Device Labeling Requirements

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Turkish Ministry of Health Labeling Requirements – HIBCC

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

Turkish Ministry of Health 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 must also be submitted to the Turkish Ministry …

New Turkish Medical Device Regulation Published and …

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

Manufacturers are required to (i) prepare and regularly update the EU declaration of conformity, (ii) establish a risk-management system, (iii) conduct a clinical …

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 - Labeling and Marketing Requirements

https://www.trade.gov/country-commercial-guides/turkey-labeling-and-marketing-requirements

All goods entering Turkey through a port of entry are cleared through customs. Full payment of duty is required unless the packages and bills of lading are …

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 (translated …

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 …

Product Labeling and IFU Language requirements for …

https://elsmar.com/elsmarqualityforum/threads/product-labeling-and-ifu-language-requirements-for-turkey.49630/

The product labels must be in Turkish. However,if instructions on product labels are clear enough making use of Universal symbols that conform to harmonized …

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 …

Medical Device Registration in Turkey - Thema Med

https://www.thema-med.com/en/medical-device-registration-in-turkey/

All Medical Devices must bear the CE marking and must be registered in the Turkish Ministry’s online database (TITUBB, Turkish Drug and Medical Device National …

Marketing, Manufacturing, Packaging & Labelling, …

https://pharmaboardroom.com/legal-articles/marketing-manufacturing-packaging-labelling-advertising-turkey/

Real and legal entities of Turkish residency must apply to the Ministry for authorization with additional forms and documents (Article 6, Licensing Regulation on …

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