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Regulatory Representation in Turkey for Medical Device Companies

Are you interested in selling your medical devices or IVDs in Turkey? If you don’t have a local presence in Turkey, you must appoint an Authorized Representative and Turkey Registration Holder (TRH) to assist with device registration and commercialization.

Turkey Registration Holder Requirements

The Turkey Registration Holder (TRH) is responsible for registering your device in the Turkish National Pharmaceutical and Medical Device Database, TITUBB. The TRH additionally handles the commercialization of your device in Turkey.

You may choose to appoint multiple distributors as registration holders; or, you can appoint an independent TRH like Emergo. If you appoint an independent TRH, we will authorize  other entities in TITUBB as approved distributors of your registered products.

Your TRH can authorize as many distributors as you would like, as there is no limit to the number of distributors associated with a registered product.

Appointing a Turkey Authorized Representative

You are also required to appoint a Turkish Authorized Representative to serve as a regulatory liaison between you and the Turkish Ministry of Health. Since Turkey’s medical device and IVD regulatory system is harmonized with Europe, you may use your EU Authorized Representative as your Authorized Representative for Turkey. Appoint Emergo as your Authorized Representative and Turkey Registration Holder.

If chosen as your in-country representative, Emergo will ensure that your Turkish medical device registration goes smoothly. Here’s how we can help:

  • We will compile all information required for your Turkish registration, including your CE Marking certificate (if applicable), Turkish labeling, IFU, Global Medical Device Nomenclature (GMDN) code, and more.
  • We will assist in submitting all application materials to TITUBB and add distributors to your registration as needed.
  • We can provide guidance on the reimbursement requirements and selecting the appropriate code for your product.
  • With consultants in Istanbul, we will coordinate communications with Turkish regulators on your behalf.

Please contact us to learn more about our Turkey Registration Holder and Authorized Representative services.

Ask us for detailed information about services.

Learn about the process, costs and timelines.

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