07-08-2022 09:14

July 8, 2022, FRIDAY

July 8, 2022, FRIDAY

OJLA Edition: 31890

REGULATORY ACT

By the Pharmaceuticals and Medical Devices Agency of Turkey, titled:

REGULATION ON CLINICAL TRIALS OF MEDICAL DEVICES

CHAPTER I

Recitals, Initial Provisions

Purpose

ARTICLE 1-

(1) The purpose of this Regulation is to lay down the rules and procedures for clinical trials of medical devices and the protection of rights of subjects volunteering to participate in such trials within the framework of European standards and good clinical practices.