The Law No. 7557 on the "Amendments to Certain Laws Related to Health and to the Decree Law No. 663", which entered into force on 24 July 2025, introduced numerous changes that directly affect the healthcare sector. One of these changes is the Additional Article 20, which was added to the Basic Law on Health Services. This article aims to address critical areas such as the placement of counterfeit medical devices on the market, unauthorized sales and technical service activities by introducing high-value administrative fines and filling existing legal gaps in these areas.
Legal Framework Introduced by the New Article
The new article stipulates that persons who place counterfeit medical devices on the market, keep them on the market, or offer them for use shall be subject to administrative fines ranging from one million to ten million Turkish Liras. Furthermore, individuals or entities that engage in the sale, advertising, distribution, or marketing of medical devices, or provide technical service activities outside the authorized locations or procedures set by the Ministry of Health, may face administrative fines ranging from five hundred thousand to five million Turkish Liras.
In cases where such acts are repeated within a year, the fines shall be doubled for each repeated offense. These fines may be imposed either jointly or separately by the Turkish Medicines and Medical Devices Agency ("Agency") and the highest local civil authority.
This provision is directly related to secondary regulations such as the Medical Device Regulation and the Regulation on the Sale, Advertisement, and Promotion of Medical Devices. According to the relevant legislation, medical devices can only be placed on the market in accordance with certain standards, and manufacturers, importers, and distributors all have specific obligations during this process.
Regarding sales and advertisement activities, only sales centers authorized by the Agency are allowed to operate. Sales and advertising activities conducted without proper authorization may be temporarily or permanently suspended under the relevant regulations. By directly associating such activities with administrative fines, Additional Article 20 extends its scope not only to authorized sales centers but also to all individuals and entities engaging in sales or advertisement activities without any official authorization.
Similarly, technical service activities must be carried out only by persons who are properly authorized under the applicable regulations. Those wishing to provide technical services are required to obtain a service certificate as well as separate work permits for the technical manager and technical staff.
Implementation and Evaluation
With the entry into force of Additional Article 20, many previously disputed legal issues regarding medical devices have been clarified. In the past, only individuals and organizations authorized by the Agency could be subjected to administrative measures. However, in the absence of a clear provision imposing monetary fines on unauthorized parties, sanctions were not seen as sufficiently deterrent. This gap has now been closed, enabling both authorized and unauthorized parties to be held equally accountable.
On the other hand, certain aspects of the implementation of Additional Article 20 remain unclear. For instance, the lack of clear procedures and principles for determining whether an act is a repeated offense may lead to differing interpretations in the application of recidivism provisions. Likewise, it remains uncertain whether minor violations and systematic breaches will be treated in the same manner, which should be clarified through secondary legislation.
In the same vein, the legislation does not clearly and predictably define the timeframe, authority, or procedure for appealing against administrative fines. These issues need to be addressed through implementation guidelines or new amendments to existing regulations.
The impact of this legislation on preventing counterfeit products from entering the market and on protecting the intellectual property rights of product owners remains to be seen as the implementation progresses.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
