While not an EU Member State, Turkey has aligned its regulatory framework for medical device manufacturers with that of the European Union.
This article outlines
With a population even larger than that of Germany, Turkey represents a major market for European medical device manufacturers. However, health-care spending in Turkey is significantly lower than in Germany.
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While Turkey is a de facto third country for the EU, the Customs Union between Turkey and the EU greatly facilitates the movement of commercial goods. As part of this agreement, Turkey has aligned its commercial law with EU law.
This is also true for medical device law. Turkey had already harmonized the EU medical device directives (MDD, IVDD, AIMDD). In the meantime, the Turkish Medicines and Medical Device Agency has reconciled Turkish medical device and IVD regulations with the EU framework (MDR, IVDR).
The Turkish law is also called Medical Device Regulation. You can download it here (in Turkish).
Since Turkey has aligned its legal framework with that of the European Union, devices which have successfully passed conformity assessment in Europe and bear a CE mark also meet the Turkish requirements.
In other words, medical devices with a CE mark may also be sold in Turkey – within the restrictions outlined below. No other conformity assessment is required.
In a notice to stakeholders, the EU Commission has made it clear that EU manufacturers are not required to have an authorized representative in Turkey and, by extension, Turkish manufacturers do not require an authorized representative in the EU either.
Moreover, manufacturers from third countries intending to supply both markets only need to appoint one authorized representative, either in Turkey or in the EU.
The Customs Union eliminates customs restrictions. After the transition periods, device registration and vigilance notifications in EUDAMED will also suffice. Manufacturers are no longer required to use the Turkish database for these aspects.
As with many EU Member States, Turkey imposes requirements on medical device manufacturers that go beyond the requirements of the MDR and IVDR.
According to Article 14 of the replaced Turkish regulation, only devices registered in the Turkish Product Tracking System (ÜTS) may be marketed in Turkey. And according to Article 110 of the Turkish MDR, this Article will continue to remain in force until EUDAMED is fully operational.
After the transition period, manufacturers must register their devices in EUDAMED.
Even once EUDAMED has become fully operational, economic operators domiciled in Turkey must continue to register in the ÜTS (Article 34 of the Turkish MDR).
The REGULATION ON THE SALE OF MEDICAL DEVICES, ADVERTISING AND SALES PROMOTION constitutes an important national law that medical device manufacturers must observe. 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 centers are clearly specified. Among other things, they include the appointment of a Competent Person, as well as staff appropriately trained by the Department of Health.
In other words, manufacturers may only market devices in Turkey through an authorized sales center. This is where it often makes sense to team up with an authorized local partner.
The only exceptions to this rule are the low-risk devices defined in Annex 3 of the Regulation, e.g., toothpaste, condoms, diapers, etc. These devices may also be sold through unauthorized outlets such as supermarkets.
In addition, according to this regulation, devices may not be advertised that
Unfortunately, this regulation has not yet been updated after the MDR was enacted. But it is expected that these provisions will remain in effect.
The Turkish MDR requires that information accompanying medical devices must be provided in Turkish.
Similar requirements also exist in the Member States of the EU.
According to NANDO, there are currently no notified bodies according to MDR/IVDR in Turkey. In its policy document, however, the EU clearly states that notified bodies may be designated in Turkey on an equal footing with notified bodies in the EU.
More notified bodies would help ease the current certification bottleneck.
The Customs Union between the EU and Turkey and alignment of Turkish national commercial law with the EU MDR and IVDR have made it much easier to market medical devices in Turkey, in particular since no additional conformity assessment is required. CE marking suffices in both cases.
Nonetheless, national regulations must be observed, such as the mandatory registration in the Turkish Product Tracking System (ÜTS), and the provisions of the regulation on the sale of medical devices, advertising and sales promotion.
Johner Institute supports medical device manufacturers in meeting the regulatory requirements of the various markets and thus getting their devices into these markets quickly and without unnecessary time and expense.