The article outlines the basics of the existing Turkish regulatory framework for the distribution of medical devices.
Table of content
The Turkish regulating authority in the sphere of medical devices has published a guidance document dedicated to the implementation of the regulation on the sale, advertising, and promotion of medical devices. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
Introduction
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. The authority also reverses the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
In particular, the document provides a comprehensive guide for the implementation of the Medical Device Sales, Advertisement, and Promotion Regulation, which was first published in the Official Gazette on May 15, 2014, under number 29001. It establishes the rules governing the sales, advertisement, and promotion of medical devices and includes definitions and key terms essential for the successful regulation of these activities.
Purpose, Basis, and Definitions
The primary objective of this guide is to outline the principles and procedures for the implementation of the Medical Device Sales, Advertisement, and Promotion Regulation. This regulatory framework is intended to ensure the proper management and oversight of medical devices in terms of their sales, advertisement, and promotion activities, providing clear standards for businesses and professionals involved in the medical device industry.
In order to assist the parties involved with the interpretation of the provisions and requirements set forth therein, the document provides definitions of the key terms and concepts used in the context of medical devices allowed for marketing and use in the country, including the following:
- Free samples: Medical devices offered free of charge to healthcare professionals and staff for promotional purposes, not for sale, and provided in compliance with Article 24 of the Regulation.
- Information: Communication about medical devices, strictly technical in nature, provided through sales centers’ official websites or social media, excluding marketing content.
- Demo device: A sample medical device provided to healthcare professionals for testing purposes.
- Training: Training programs required for responsible managers, clinical support staff, sales and promotion officers, and medical device registration officers, as specified in the Regulation.
- Protocol: A formal document signed between the institution and training organizations for the execution of training programs.
- Sales center: Locations authorized for the sale of medical devices.
- Medical device sales center: Centers authorized within the scope of the Regulation.
- Medical device registration staff: Individuals who register medical devices within the institution’s system, possessing at least a high school education and a certification of competence.
- Qualification certificate: A document issued to individuals who have completed necessary training and passed exams, certifying their competency.
- Authorization certificate: A permit allowing a legal or natural person to operate a medical device sales center.
Application, Authorization, Work Certificate, and ID Cards
In accordance with the applicable regulatory requirements, natural or legal persons intending to operate a medical device sales center must submit an application to the relevant directorate in accordance with Article 5 of the Regulation. The format and content of the application are outlined in Annex 1 of the guide.
Upon the successful evaluation of the application, the directorate issues the Medical Device Sales Center Authorization Certificate (Annex-2) to the applicants. This certificate is crucial for businesses seeking to sell medical devices.
Medical device sales centers must provide qualification certificates for key personnel, including the responsible manager, sales and promotion staff, and clinical support staff, to the directorate. These documents must follow the formats presented in Annexes 3, 4, and 5.
Personnel working in the sales centers are required to carry identity cards issued by the directorate. These cards must feature specific details, including a recent photograph sealed with a cold stamp, and adhere to the size and material specifications (8.5×5.5 cm Teslin paper with matte PVC lamination).
Identity cards must be renewed periodically, with all applications for identity cards submitted by January 1, 2028, to retain rights under the regulation.
Education, Exams, Qualification Certificates, and Other Matters
As further explained in the document, training is mandatory for individuals seeking to become responsible managers, sales and promotion staff, clinical support personnel, or medical device registration personnel. The training programs are carried out by authorized institutions and include both legislative and medical ethics components.
Candidates must complete at least 90% of the training to qualify for the final exam. Exams are administered either in person or online, depending on the institution’s arrangements.
Candidates must score a minimum of 70 out of 100 to pass. Successful candidates receive a qualification certificate, which serves as formal recognition of their expertise in the field.
In addition to training, the relevant chapter of the guidance outlines various requirements for maintaining qualifications. For example, medical device registration personnel must renew their certifications regularly and attend updated training programs when necessary.
Failure to comply with these requirements results in the invalidation of their certification. The guidance also establishes provisions for exceptional cases, such as personnel who have worked for more than four years in the field of medical devices, who may qualify for higher roles without needing to re-take basic training.
Conclusion
In summary, the Medical Device Sales, Advertisement, and Promotion Regulation establishes a critical framework that ensures the responsible and effective management of medical devices in the market, while compliance with the relevant requirements set forth therein is vitally important in the context of public health protection.
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