The article provides a general overview of the current regulatory framework for the distribution and advertising of medical devices intended to be marketed and used in Turkey.
Table of content
The Turkish national regulating authority in healthcare products has published a second revision of a guidance document dedicated to implementing the Medical Device Sale, Advertising, and Promotion Regulation.
The document is intended to assist medical device manufacturers and other parties involved in interpreting and following the relevant regulatory requirements.
At the same time, the authority also reserves the right to change the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
The present document is intended to serve as a comprehensive guide for implementing the Medical Device Sales, Advertisement, and Promotion Regulation, as published in the Official Gazette on 15/5/2014, under number 29001.
The purpose of the guidance is to describe in detail the regulatory approach to be followed by medical device manufacturers, wholesalers, and distributors, as well as other parties involved in operations with medical devices to ensure compliance with the existing legal framework.
Purpose, Basis, Definitions
Based on the provisions of the Regulation above, the guidance document highlights the critical points associated with the procedures and principles of medical device sales, advertising, and promotion.
To assist the parties involved, the document provides definitions of the main terms and concepts used in the Regulation, including such terms as “Free Sample”, “Information”, “Demo Devices”, “Training”, “Protocol”, “Sales Center”, “Exam”, “Medical Device Registration Personnel”, “Medical Device Sales Center”, “Medical Device Market Announcement”, “Qualification Certificate”, “Authorization Certificate”, and “Authorized Organization”.
Application, Authorization, Employment, and Identification
The document further outlines specific aspects of operations with medical devices intended to be marketed and used in the country. Key points addressed in the guidance include among other things, the following ones:
- Application Process: Entities desiring to become authorized medical device sales centres must apply to the directorate as per Article 5 of the Regulation.
- Authorization Certificate: Successful applicants receive an authorization certificate following a thorough evaluation to be conducted by the authority.
- Employment Certificate: Issued to responsible managers, sales, promotion, and clinical support personnel at medical device sales centres.
- Identity Card: Issued to qualified personnel, these cards are printed on specific paper dimensions and feature a color photograph.
- Training: According to the guidance, training in the sphere of medical devices involves distance education methods, with a minimum 90% participation requirement. Training is categorized under legislation and medical ethics.
- An examination is intended to measure candidates’ proficiency post-training. Successful candidates (scoring 70 and above) can apply for a qualification certificate.
- Qualification Certificate: Upon successful completion of the abovementioned examination, candidates who meet the requirements (which include payment of relevant fees) are eligible to obtain a qualification certificate.
Additional Aspects
The scope of the guidance also covers some other matters to be considered by medical device manufacturers, wholesalers, distributors, and other parties involved in operations with medical devices in Turkey. These aspects include, among other things, the following ones:
- Fee Structure: The document outlines the details regarding the qualification certificate fee are publicly available.
- Mandatory Updated Training: Under the applicable regulations, holders of qualification certificates may be required to undergo updated training programs.
- Registration Restrictions: The authority explicitly states that starting 1/1/2025, only qualified personnel can register medical devices in the Product Tracking System (ÜTS).
- ÜTS Registration: Specific criteria for registering medical devices in the ÜTS by different personnel categories.
- Special Provisions for Personnel: Details steps for sales and promotion personnel or clinical support personnel aspiring to become responsible managers.
- Clinical Support Staff Limitations: The document outlines the extent of permissible activities for clinical support staff, adhering to the Regulation on Job and Task Descriptions of Healthcare Professionals.
Conclusion
In summary, the present guidance document describes in detail the legal framework for implementing the Medical Device Sales, Advertisement, and Promotion Regulation.
It covers various definitions, procedures, certification, training, examination, and operational guidelines.
The relevant protocols and methods described in the guidance are intended to ensure a standardised and regulated approach to medical device sales, advertising, and promotion within the healthcare sector, maintaining the integrity and efficacy of medical device distribution and usage.
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