Guide on the Implementation of the Regulation on the Sale, Advertising and Promotion of Medical Devices: TCS-KLVZ-08

This document outlines the implementation of the Regulation on the Sale, Advertising, and Promotion of Medical Devices. Key components include:

• Application Process: Steps to become a medical device sales center.
• Education and Examination: Requirements for registration and training of personnel.
• Information Sharing: Guidelines for sharing information, promoting products, and announcing market releases.
• Online Sales: Regulations governing the sale of medical devices online.
  

Compliance Requirements:

• Emphasis on adhering to technical documentation, user manuals, and other relevant materials.
• Restrictions on sales and advertising practices.
• Authorization and Certification:
  Requirements for sales centers to obtain necessary certifications.
  Prohibition of selling medical devices through unauthorized social media accounts or websites.
• The document includes updates and amendments to the Promotion Regulation.

Source: https://www.titck.gov.tr/duyuru/tibbi-cihaz-satis-reklam-ve-tanitim-yonetmeliginin-uygulanmasina-iliskin-kilavuz-30092024131709

Region: Turkey