Turkey Medical Device Registration


Turkey Medical Device Registration Overview

The Turkish medical device market has seen significant and consistent growth over the past decade. From  2021onwards, Turkey Medical Device Registration Requires to abide by the EU  EU Medical Devices Regulation (MDR) 2017/745 and In Vitro Diagnostics Medical Devices Regulation (IVDR) 2017/746. This enhanced international trade leading several global companies to launch their medical devices in the country.

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    Regulatory Authority: Turkish Medicines and Medical Devices Agency (TITCK)
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    Regulation: Medical Device Regulations (MDR) 2017/745, In Vitro Diagnostic Devices Regulations 2017/746
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    Regulatory Pathway: CE marking is mandatory followed by Registration/Notification in the Product Tracking System (UTS)
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    Turkey Local Authorized Representative: European Authorized Representative (EAR) for foreign (non-EU/non-Turkey) manufacturers
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    QMS Requirement: ISO 13485:2016
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    Assessment of Technical Data:  Notified Body for CE marking
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    Validity of License: Unlimited
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    Submission Format: Paper
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    Translation: Translated Documents in Turkish

Device Classification

Turkey follows the same medical device classification as given in the EU MDR and IVDR. Determining the device classification can be challenging and hence having backed by an experienced regulatory consultant is quite crucial here.

Medical Device Classes -

ClassRisk
Class ILow
Class IIaModerate
Class IIbModerate to High
Class IIIHigh

In Vitro Diagnostic Device Classes -  

ClassRisk
Class ALow
Class BModerate
Class CModerate to High
Class DHigh

Turkey Local Authorized Representative

Now, due to the custom union agreement, the EU manufacturers do not require to appoint a local authorised representative to place their devices in the market.

Other foreign manufacturers are required to appoint a European Authorised Representative (EAR) to place the devices in the Turkey market.

Medical Device Registration

CE marking is a conformity that is required by the manufacturers to place their device in the Turkey market. CE marking is issued through a conformity assessment carried out by the notified body. Now, Turkey is authorised to appoint notified bodies in accordance with EU MDR and IVDR.

The companies are required to register in Central Registration System (MERSIS) registration and register the device in the Product Tracking System (UTS).

Process flow

Post-approval Device Lifecycle Management

Freyr supports foreign manufacturers in end-to-end Medical Device lifecycle management, including post-approval activities, such as:

  • Post approval change management - modifications to existing medical device approvals such as the addition of new variants, accessories; addition of new indications of use among others
  • Maintenance of ISO 13485:2016 and CE certification
  • Renewal of licenses
  • Liaising between Notified body and the manufacturer

With various authorization bodies involved, foreign manufacturers need to comply with multiple sets of regulations in each individual process for device approvals. Obtaining a CE marking and further adhering to state-wise regulations needs extensive Regulatory knowledge. At times, without a proven Regulatory partner, navigating through all the device requirements might be challenging for market entrants. To assist manufacturers, Freyr provides end-to-end Regulatory services to expedite approvals for medical devices.

Freyr Expertise

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