Introduction
Medical device sales in pharmacies in Turkey are legally possible, but they are not unlimited. A pharmacy may sell certain medical devices and medical materials within the boundaries of Turkish pharmacy law and medical device legislation. However, the pharmacy cannot sell every device merely because it is health-related. The legal analysis depends on the device’s intended use, user category, risk level, whether it must be used or applied exclusively by healthcare professionals, whether it is connected with administration of medicinal products, whether it is in a pharmaceutical form, and whether it falls within the scope announced by the Turkish Medicines and Medical Devices Agency, known as TİTCK.
This topic is important because pharmacies increasingly sell products such as blood pressure monitors, glucose meters, nebulizers, thermometers, pregnancy tests, wound care products, orthopaedic supports, masks, syringes, medical dressings, ostomy products, incontinence products, compression stockings and other patient-use devices. These products create commercial opportunity, but also legal responsibility.
A pharmacy is not an ordinary health shop. Under the Regulation on Pharmacists and Pharmacies, a pharmacy is a healthcare institution opened under the ownership and responsible management of a pharmacist; the same regulation defines pharmacy services as healthcare services involving medicines, patient counseling, product safety and professional responsibility. The pharmacist’s responsibilities expressly include helping patients safely and effectively use medicines, medicine-administration tools, medical devices and medical materials.
Therefore, selling medical devices in a pharmacy is not merely a retail transaction. It is a regulated healthcare activity involving product legality, correct supply, patient information, safety, storage, traceability, advertising compliance and liability risk.
Legal Framework for Medical Device Sales in Pharmacies
The main legal sources are the Regulation on Pharmacists and Pharmacies, the Medical Device Regulation, the Medical Device Sales, Advertising and Promotion Regulation, the In Vitro Diagnostic Medical Device Regulation, TİTCK product tracking systems and general consumer and liability rules.
The Medical Device Regulation aims to set high quality and safety standards for medical devices and accessories intended for human use, with the goal of protecting patients, users and other persons at a high level. It regulates placing devices on the market, making them available and putting them into service.
The Medical Device Sales, Advertising and Promotion Regulation regulates sales, advertising, information, clinical support, promotion, marketing and technical service activities concerning devices within the scope of the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation. It also covers registration procedures in TİTCK’s records and information management systems.
The Regulation on Pharmacists and Pharmacies is directly relevant because it identifies what may be sold in pharmacies. Article 42 provides that certain products are sold exclusively in pharmacies, while other products may be sold in pharmacies. Among the products that may be sold in pharmacies are medical materials whose scope is determined by TİTCK. The same article states that the scope of medical materials is determined and announced by TİTCK at intervals according to need.
This means pharmacy medical device sales sit at the intersection of pharmacy law and medical device law. A product may be a lawful medical device in Turkey, but that does not automatically mean every pharmacy may sell it without limits. Conversely, a pharmacy may sell certain medical devices without becoming a general medical device sales center, but only within the legal exception.
What Medical Devices Can Pharmacies Sell?
The key rule is that pharmacies may sell medical devices and medical materials that fall within the scope permitted for pharmacy sale. Article 42 of the Regulation on Pharmacists and Pharmacies states that “medical materials whose scope is determined by TİTCK” may be sold in pharmacies. It also provides that the scope of medical materials is periodically determined and announced by the Agency according to need.
In practice, this category may cover patient-use and pharmacy-appropriate products such as wound care materials, bandages, medical dressings, syringes, needles used with medicines, blood pressure monitors, glucose meters, test strips, thermometers, nebulizer accessories, masks, orthopaedic supports, incontinence products and other similar items depending on current TİTCK classification and announcements.
However, the pharmacist should not assume that every device is automatically allowed. A device’s packaging, intended use, technical risk, user profile and regulatory classification must be considered. For example, a simple digital thermometer and a surgical implant are both health-related products, but their legal treatment is very different.
A pharmacy should apply a product-by-product compliance review before stocking medical devices. The review should ask: Is this a medical device? Is it permitted for pharmacy sale? Is it intended for direct patient or consumer use? Does it require professional application? Is it registered in the relevant product system? Are labeling and instructions complete? Are there storage conditions? Is there a technical service or warranty obligation? Does advertising material contain prohibited health claims?
Devices That Pharmacies Cannot Sell
The most important limitation is found in the Medical Device Sales, Advertising and Promotion Regulation. Article 33 provides that, except for medical devices placed on the market in pharmaceutical form and devices used in the administration of human medicinal products, devices that must be used or applied exclusively by healthcare professionals cannot be sold in pharmacies. Other devices may be sold in pharmacies without requiring any separate authorization or permission, and the Agency announces the devices that may be sold by pharmacies.
This rule is decisive. A pharmacy cannot sell a device merely because a patient wants to buy it. If the device is exclusively for use or application by healthcare professionals, pharmacy sale is prohibited unless it falls within the specific exceptions stated in the regulation.
Examples of high-risk or professional-use devices may include certain surgical devices, implantable devices, hospital-use equipment, devices requiring professional application, devices requiring technical installation by trained healthcare professionals, or devices not intended for direct patient use. Each product must be evaluated according to its intended purpose and applicable classification.
The pharmacist should be especially careful with products marketed by aggressive suppliers. A supplier’s statement that “all pharmacies sell this” is not a legal guarantee. The pharmacist should check the device’s regulatory status, user instructions and TİTCK classification before placing it on pharmacy shelves.
Difference Between Medical Devices and Medicines
A common compliance mistake is confusing medicines, medical devices, cosmetics, food supplements and general health products. The legal category matters because each product group has different rules.
A medicine generally acts through pharmacological, immunological or metabolic action. A medical device generally acts through physical, mechanical, technological or diagnostic means, although the legal definition must be assessed under the Medical Device Regulation. A cosmetic product has a different regulatory framework, and a food supplement is not a medicine or medical device merely because it is sold in a pharmacy.
This distinction matters in pharmacy practice. For example, a wound dressing may be a medical device. A medicated cream may be a medicinal product. A skin moisturizer may be cosmetic. A vitamin product may be a food supplement. A glucose meter may be a medical device, while insulin is a medicine. A test strip may be an in vitro diagnostic device depending on its intended use.
Misclassification can cause legal problems. If a pharmacy sells a product as if it were a simple health product when it is actually a regulated medical device, the pharmacy may fail to meet tracking, labeling, storage or advertising requirements. If a product is promoted as treating disease but is not authorized as a medicine or device for that purpose, health claim and advertising liability may arise.
In Vitro Diagnostic Devices in Pharmacies
Some pharmacy-sold products may fall under the in vitro diagnostic device category. Pregnancy tests, blood glucose strips, certain self-test kits and diagnostic products may be regulated under the In Vitro Diagnostic Medical Device Regulation. This regulation was published together with the 2021 medical device framework and covers in vitro diagnostic medical devices.
Pharmacies should treat self-test products carefully. A self-test device may be lawful for direct consumer use if it is designed and authorized for that purpose. However, a professional laboratory diagnostic device may not be suitable for ordinary pharmacy sale to consumers. The key question is intended user and intended use.
The pharmacy should also avoid interpreting test results beyond its professional role. The pharmacist may explain how the device is used according to instructions, but should not provide medical diagnosis beyond lawful professional counseling. If a test result is abnormal or unclear, the patient should be directed to a physician or appropriate healthcare provider.
Authorization and Sales Center Rules
Medical device sales centers in Turkey are normally subject to authorization, inspection, personnel and record rules. Provincial health directorates conduct authorization and inspection procedures for medical device sales centers. The İstanbul Provincial Health Directorate describes its relevant unit as responsible for authorization and inspection of medical device sales centers operating in Istanbul.
Pharmacies are treated differently for certain pharmacy-permitted devices. Article 33 of the Medical Device Sales, Advertising and Promotion Regulation provides that devices outside the professional-use prohibition may be sold in pharmacies without requiring any separate authorization or permission.
This exception is important but should not be misunderstood. It does not convert the pharmacy into an unrestricted medical device sales center. It allows pharmacies to sell the devices that fall within the permitted pharmacy category. If a pharmacy begins selling devices outside that scope, especially professional-use devices, high-risk devices or devices requiring sales center authorization, it may exceed the exception.
Therefore, a pharmacy should keep its device portfolio within patient-use and pharmacy-appropriate categories. If the pharmacy wishes to enter broader medical device sales, a separate legal assessment is required.
Product Tracking and Registration Obligations
Medical device traceability is a central regulatory concern. The Medical Device Sales, Advertising and Promotion Regulation provides that sales centers must register devices they place on the market or make available in TİTCK’s records and information management systems, keep information up to date and perform single-movement notification transactions to ensure traceability. It also states that sales centers must keep records relating to infrastructure, personnel and devices, comply with TİTCK systems, preserve activity documents for five years and present them to TİTCK or the provincial directorate upon request.
For pharmacies, the exact technical obligation may depend on the device category, system status and TİTCK rules. However, the compliance principle is clear: medical device sales must be traceable. A pharmacy should not stock unregistered, undocumented, suspicious or grey-market devices.
The pharmacy should preserve invoices, supplier information, product registration details, batch or serial data where available, warranty documents, user manuals, recall notices and patient delivery records where relevant. For high-risk or expensive devices, documentation should be stronger.
Traceability protects the pharmacy during recalls, patient complaints, product defect allegations and inspections. If a device injures a patient or is recalled, the pharmacy must be able to identify where it obtained the product and, where possible, to whom it was supplied.
Storage and Preservation of Medical Devices
Medical devices must be stored according to manufacturer instructions and applicable standards. Some devices require protection from humidity, temperature extremes, sunlight, dust, impact or contamination. Sterile products require special attention because damaged packaging may compromise sterility.
The Medical Device Sales, Advertising and Promotion Regulation states that sales centers must create the necessary infrastructure to preserve devices under the conditions required by the manufacturer and international standards.
Although pharmacies are not always ordinary sales centers for the devices they are permitted to sell, the same safety logic applies. A pharmacy that sells a sterile dressing with damaged packaging, a glucose strip stored under improper humidity, a thermometer with damaged calibration integrity or a device past its usable period may face liability.
The pharmacist should establish storage rules for devices. Sterile devices should not be opened, crushed or exposed to moisture. Electronic devices should be kept away from heat and humidity. Test strips should be stored according to package conditions. Devices with expiry or calibration dates should be monitored.
Instructions for Use and Patient Counseling
Medical device sales in pharmacies often require patient counseling. The pharmacist should ensure that the patient understands what the device is for, how it is used, what warnings apply, when professional medical assistance is necessary and how the device should be stored.
This is especially important for devices such as glucose meters, blood pressure monitors, nebulizers, inhalation chambers, wound dressings, compression products and self-test kits. Incorrect use may produce inaccurate results or harm. For example, a patient using a blood pressure monitor incorrectly may misinterpret readings. A patient using a glucose meter with expired strips may obtain unreliable results. A patient applying a wound product incorrectly may delay treatment.
The pharmacist’s duty under pharmacy regulation includes helping patients use medicines, application tools, medical devices and materials safely and effectively and ensuring that they have sufficient understanding.
This does not mean the pharmacist replaces the physician. It means the pharmacist provides lawful, product-related counseling and directs the patient to medical care where needed.
Advertising and Promotion Limits
Medical device advertising is regulated. The Medical Device Sales, Advertising and Promotion Regulation covers advertising, information, clinical support, promotion, marketing and technical service activities. Sales centers must conduct advertising and promotion activities in accordance with the regulation.
Pharmacies should be cautious with posters, window displays, social media posts, discount campaigns and supplier-provided promotional materials. A medical device may be permitted for sale, but that does not automatically allow aggressive advertising or health claims.
Risky statements include “guaranteed diagnosis,” “doctor-level treatment at home,” “cures pain,” “prevents disease,” “best device for all patients,” “no need to see a doctor,” or “clinically proven miracle result,” unless the claim is legally permitted, evidence-based and consistent with the authorized intended use.
Advertising must not mislead patients, exaggerate performance, hide risks, promote off-label use or suggest that a device replaces professional medical evaluation when it does not.
Online Sales and Digital Risks
Pharmacy online sales are heavily restricted in Turkish law, especially for medicines and pharmacy-exclusive products. Article 43 of the Regulation on Pharmacists and Pharmacies prohibits online or electronic sale of medicines and the products listed in Article 42/1, and also prohibits opening websites in the name of pharmacies or pharmacy pharmacists.
For medical devices, the analysis can be more complex because not all devices fall into Article 42/1. However, pharmacies should be extremely cautious with online channels. Even if a device may be sold by a pharmacy physically, pharmacy-branded websites, product catalogues, order forms, social media “DM to order” systems and WhatsApp sales may create regulatory, advertising, consumer law and data protection risks.
The safest approach is not to turn the pharmacy into an online medical device shop unless the product category, pharmacy law, medical device law, e-commerce rules, advertising rules and TİTCK requirements are fully assessed. A pharmacy should especially avoid online sale of devices connected with diagnosis, treatment, prescription medicine administration, controlled products, or products requiring professional counseling.
Warranty, Technical Service and Defective Devices
Some medical devices require warranty, calibration, maintenance or technical service. Blood pressure monitors, glucose meters, nebulizers and electronic devices may malfunction or produce inaccurate results if defective.
The Medical Device Sales, Advertising and Promotion Regulation covers technical service activities and the broader framework of device sales and after-sales responsibilities. It also requires sales centers to keep relevant records and comply with TİTCK systems.
A pharmacy selling devices should be clear about warranty documents, supplier contact information, return policy, defect reporting and technical service routes. The pharmacist should not attempt unauthorized technical repair unless legally and technically competent. If a patient complains that a device is inaccurate, damaged or unsafe, the pharmacy should document the complaint, stop selling suspicious stock if needed, contact the supplier and follow recall or corrective action instructions.
Recalls and Corrective Actions
Medical devices may be recalled or subject to field safety corrective action. A recall may occur because of manufacturing defect, inaccurate measurement, sterility failure, labeling problem, software defect, battery hazard or other safety issue.
A pharmacy should monitor supplier and TİTCK communications. If a recalled device is in stock, it should be removed from sale immediately. If the pharmacy can identify patients who purchased affected devices, appropriate communication may be required depending on the recall instructions.
Traceability is essential. Without records, a pharmacy may be unable to identify affected products or patients. For high-risk devices, pharmacies should preserve serial numbers and delivery records where possible.
SGK and Reimbursement Issues
Some medical devices and medical materials may be connected with SGK reimbursement, medical reports, prescriptions or patient contribution rules. For example, certain ostomy products, diabetes supplies, wound care materials, orthopaedic products or other medical supplies may be supplied under reimbursement rules depending on current SGK/SUT provisions.
A pharmacy should not assume reimbursement merely because the device is medically necessary. SGK payment may depend on prescription, medical report, diagnosis, quantity limits, physician specialty, product code, MEDULA entry and documentation.
If the pharmacy supplies a reimbursed medical device or material, the pharmacist should preserve the prescription, report, delivery documents, product records, invoices and system entries. A later SGK audit may examine whether the product was properly supplied and whether reimbursement rules were satisfied.
Patient Data and Privacy
Medical device sales may involve sensitive health data. A patient buying a glucose meter may reveal diabetes. A patient buying incontinence products may reveal a private health condition. A patient buying ostomy supplies may reveal surgical history. A patient buying a pregnancy test may reveal reproductive privacy.
The pharmacist must protect patient privacy. Pharmacy regulation expressly requires the pharmacist to protect the patient’s private life and confidentiality.
Employees should not discuss device purchases publicly. Patient information should not be shared with suppliers, relatives, couriers or third parties without lawful basis. If the device sale involves records, warranty registration or SGK documentation, only necessary data should be processed and retained securely.
Liability of the Pharmacist
The pharmacist may face liability in several situations: selling a prohibited device, selling a device intended exclusively for healthcare professionals, supplying an unregistered or unsafe product, failing to provide necessary instructions, making misleading claims, ignoring a recall, selling a defective or expired device, mishandling SGK documents or disclosing patient data.
Civil liability may arise if the patient suffers harm because of incorrect device supply or inadequate warning. Administrative liability may arise under pharmacy and medical device rules. Professional disciplinary liability may arise if the pharmacist acts contrary to professional ethics or patient safety. In serious cases involving counterfeit devices, intentional misconduct or patient injury, criminal-law questions may arise.
The pharmacist’s best defense is preventive compliance: lawful sourcing, product verification, proper storage, clear counseling, accurate records, advertising control and recall readiness.
Practical Compliance Checklist for Pharmacies
A pharmacy selling medical devices should use the following checklist:
Confirm whether the product is a medical device, in vitro diagnostic device, medicine, cosmetic, supplement or other product.
Check whether the device may lawfully be sold in pharmacies.
Do not sell devices that must be used or applied exclusively by healthcare professionals unless a legal exception applies.
Verify supplier authorization and product traceability.
Check product registration, labeling, CE status and Turkish instructions where applicable.
Preserve invoices, delivery documents, serial numbers and warranty documents.
Store devices according to manufacturer instructions.
Separate expired, damaged, recalled or suspicious devices from saleable stock.
Provide patient counseling on correct use and warnings.
Avoid misleading health claims and unauthorized promotion.
Do not use supplier posters or social media content without legal review.
Protect patient privacy.
Document complaints and adverse incidents.
Follow recall and corrective action instructions.
Review SGK reimbursement rules separately where applicable.
Common Mistakes
The first common mistake is assuming that every health-related device can be sold in pharmacies. Turkish law prohibits pharmacy sale of devices that must be used or applied exclusively by healthcare professionals, except for specified exceptions.
The second mistake is relying only on supplier statements. The pharmacist should verify legal status and product documentation.
The third mistake is treating medical device sale as ordinary retail. Device storage, labeling, instructions, warranty and safety warnings matter.
The fourth mistake is using exaggerated advertising claims. Medical device promotion must remain within the authorized intended use.
The fifth mistake is selling devices online under the pharmacy name without reviewing pharmacy law, device law and advertising restrictions.
The sixth mistake is failing to preserve product records. Without documents, recalls, complaints and inspections become difficult.
The seventh mistake is mishandling SGK-covered device supplies. Reimbursement requires separate compliance.
Frequently Asked Questions
Can pharmacies sell medical devices in Turkey?
Yes, pharmacies may sell certain medical devices and medical materials within the scope permitted by Turkish law. Article 42 of the Regulation on Pharmacists and Pharmacies states that medical materials whose scope is determined by TİTCK may be sold in pharmacies.
Can pharmacies sell every medical device?
No. Devices that must be used or applied exclusively by healthcare professionals cannot be sold in pharmacies, except for devices in pharmaceutical form and devices used in the administration of human medicinal products. Other permitted devices may be sold in pharmacies without separate authorization, and TİTCK announces the devices that may be sold by pharmacies.
Do pharmacies need a separate medical device sales center authorization?
For devices that fall within the pharmacy exception, pharmacies may sell them without separate authorization or permission. However, this does not allow unrestricted sale of all medical devices.
Are medical devices subject to tracking?
Medical device sales centers are required to register devices in TİTCK’s records and information systems, keep information current and perform movement notifications to ensure traceability. Pharmacies should preserve device supply records and comply with applicable tracking requirements depending on the device category.
Can a pharmacy advertise medical devices?
Advertising and promotion of medical devices are regulated. Pharmacies should avoid misleading claims, exaggerated benefit statements, disease-cure promises and product promotions inconsistent with the device’s authorized intended use.
Conclusion
Medical device sales in pharmacies in Turkey are legally permitted, but only within defined boundaries. Pharmacies may sell medical materials and devices allowed under pharmacy law and TİTCK’s scope determinations. However, devices that must be used or applied exclusively by healthcare professionals cannot be sold in pharmacies, except for devices in pharmaceutical form and devices used in the administration of human medicinal products.
The legal reason is clear: medical devices can affect diagnosis, treatment, monitoring and patient safety. A pharmacy is a healthcare institution, and the pharmacist has a duty to help patients use medical devices and materials safely and effectively.
For pharmacists, the safest approach is product-based compliance. Before stocking a device, the pharmacy should check whether it is permitted for pharmacy sale, whether it is registered and traceable, whether it is intended for patient use, whether it needs special storage, whether it has proper labeling and instructions, whether SGK rules apply, and whether advertising claims are lawful.
The pharmacy should also preserve invoices, supplier documents, warranty information, product records and recall communications. It should train staff, protect patient privacy, avoid misleading claims and respond quickly to device complaints.
In Turkey, medical device sales can be a valuable part of pharmacy service, but only if they are conducted as a regulated healthcare activity rather than ordinary retail trade. A legally compliant pharmacy protects patients, avoids administrative sanctions, reduces liability and strengthens professional trust by selling only appropriate medical devices under proper legal, technical and ethical standards.
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