The Ministry of Health (“Ministry”) introduced the Regulation on Dialysis Centers (“Regulation”), which entered into force by publication in the Official Gazette on March 1, 2019. The Regulation sets out the principles and procedures regarding centers and units conducting dialysis treatments.
The Regulation provides detailed rules with respect to the planning, establishment, and activities of centers and units conducting dialysis treatment for patients with acute or chronic kidney failure, as well as the application of the dialysis treatment methods.
In this respect, persons and legal entities wishing to establish a dialysis center in the areas determined by the Ministry must apply to the Ministry for an investment permit in accordance with the provisions of the Regulation. In addition, the Regulation requires permit owners to obtain license and activity permits regarding their dialysis centers/units by applying to the provincial directorates of the Ministry and submitting the information and documents listed in Article 19 of the Regulation.
Furthermore, in order for the Ministry to conduct its inspection activities, dialysis centers/units must keep the records specified in the Regulation regarding the dialysis treatments in an orderly and accessible manner, enter the relevant data to the Turkish Dialysis Data System (TÜRKDİVES), and submit such information to the Ministry upon the Ministry’s request. In this regard, the Regulation sets forth certain administrative sanctions for the dialysis centers and units that fail to enter such data or enter incomplete or incorrect data on the TÜRKDİVES.
The full text of the Regulation is available here.
The Ministry continues to provide guidance for companies in the healthcare sector regarding dialysis centers and dialysis treatments. The companies wishing to establish a dialysis center must carefully review the requirements set forth under the Regulation and make their applications to the Ministry accordingly.