TR 
EN 
Retail Sale of Medical Devices
The Medical Device Sales, Advertising and Promotion Regulation (“Regulation”) stipulates that only the determined devices under the Regulation are allowed to be sold in retail market without the requirement for a “medical device sales center certificate”. Pursuant to the recent amendment made in the Regulation on September 2, 2020, medical devices that should exclusively be used or applied by healthcare providers, other than those that are placed on the market in pharmaceutical form or used in the administration of medicinal products for human use were prohibited to be sold in retail market by pharmacies whereas medical devices that are not subject to the mentioned restriction are allowed to be sold in pharmacies without any authorization or permission.
Turkish Medicines and Medical Devices Agency (“TITCK”) has recently made an announcement on December 11, 2020 clarifying the medical devices that are allowed to be sold in retail market explaining that with the abovementioned amendment, pharmacies were allowed to sell medical devices that are placed on the market in pharmaceutical form or used in the administration of medicinal products for human use, except those that should exclusively be used or applied by healthcare providers, without the requirement of obtaining a medical device sales center certificate.
Accordingly, except for the devices that are: (i) only allowed to be sold, adapted or applied in hearing aid centers, custom-made prosthesis and orthosis centers, optician institutions, or dental prosthesis laboratories; and (ii) intended to be used or applied exclusively by healthcare professionals or that require application in medical device sales centers, the medical devices:
· placed on the market in pharmaceutical form;
· used in the administration of medicinal products for human use;
· allowed to be sold to consumers in retail market pursuant to the Medical Device Sales, Advertising and Promotion Regulation; and
· for individual use are allowed to be sold in retail market by pharmacies without obtaining a medical device sales center certificate.
Service Procurements from Medical Device Technical Service Providers
To ensure patient and product safety, the persons and organizations that carry out maintenance and repair activities regarding the usage processes of medical devices after the introduction of medical devices to the market are required to be registered with the database of the Ministry of Health within the framework of the relevant legislation. With this respect, to monitor the technical services offered to medical devices of healthcare providers that require maintenance and repair operations during their use, the medical device technical service providers and their technical personnel are required to register with and -when necessary- update the Product Tracking System (ÜTS) of the Ministry of Health since March 2019 in accordance with the procedures and principles determined by the TITCK.
TITCK has recently published the Circular Regarding Registration of Medical Device Technical Service Providers and Related Technical Personnel numbered 2020/5 dated December 9, 2020 (“Circular”). Accordingly, health service providers belonging to public or private legal entities or real persons that will procure services from medical device service providers should require the medical device technical service providers to be registered as "Medical Device Service Station" and their technical personnel as “Technical Personnel” on Product Tracking System (ÜTS). Additionally, a “service place competence certificate” valid in accordance with the applicable standards of the Turkish Standards Institute with respect to the scope of activity of the relevant medical device service provider should be required by the health service providers when procuring mentioned services.
Lastly, with the Circular, TITCK’s Circular on Registration of Medical Device Technical Service Providers and Related Technical Personnel numbered 2019/1 dated February 11, 2019 has been revoked.
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