How Are Aesthetic Products and Devices Regulated in Türkiye? A Patient's Verification Guide to TİTCK, ÜTS and CE Marking

Aesthetic products in Türkiye are not all regulated the same way. Botulinum toxin products are medicines licensed by the Turkish Medicines and Medical Devices Agency (TİTCK). Dermal fillers, lasers and similar energy-based equipment fall under the Turkish Medical Device Regulation, which is aligned with EU Regulation 2017/745. These products carry CE marking and are registered in the national Product Tracking System (ÜTS). Topical cosmetics have their own regulation, and it does not cover anything meant to be injected. As a patient you can ask for the product name, lot (batch) number and expiry date, and you can ask to see the sealed packaging. For devices, you can ask for the exact model.

Who regulates what?

The Turkish Medicines and Medical Devices Agency (TİTCK) oversees medicines, medical devices and cosmetics in Türkiye. Each follows a different regulation, and knowing which group a product belongs to tells you how you can check it.

Medicines: botulinum toxin

Botulinum toxin products are licensed in Türkiye as medicines. TİTCK sent a letter to physicians dated 7 February 2024 that sets out the following:

• Counterfeits of licensed products have been found on the market, and unlicensed products have been obtained outside the legal supply chain.
• Botulism cases reported to the Turkish Pharmacovigilance Centre (TÜFAM) have increased significantly.
• Physicians should use only licensed medicines. These should be obtained only through licensed pharmaceutical warehouses, not from other firms, individuals or sources of unknown origin such as social media.
• Medicine packs must carry a unique QR-type code that is tracked in the Pharmaceutical Track and Trace System (İTS). However, counterfeit products are known to carry codes copied from genuine packs.

The last point matters for patients. A code that scans correctly does not, on its own, prove that a product is genuine. TİTCK publishes an up-to-date List of Licensed Products for human medicines. A product on that list is licensed. The list cannot tell you whether the vial in front of you is that product.

Medical devices: fillers, lasers and energy-based equipment

Medical devices are governed by the Medical Device Regulation (Tıbbi Cihaz Yönetmeliği), published in the Official Gazette of 2 June 2021 (No. 31499, repeat issue). According to TİTCK, it was drafted in line with EU Regulation (EU) 2017/745 on medical devices (the MDR). It was amended in 2022 and in 2024.

Article 1 of the regulation also brings in certain products that have no medical purpose, listed in its Annex XVI. The EU's Commission Implementing Regulation (EU) 2022/2346 sets common specifications for these product groups, which include:

• Substances or items for facial or other dermal or mucous-membrane filling by subcutaneous, submucous or intradermal injection.
• Equipment intended to reduce, remove or destroy fat tissue.
• High-intensity electromagnetic radiation equipment, such as lasers and intense pulsed light (IPL), for skin resurfacing, tattoo or hair removal, or other skin treatment.

So a filler or a laser falls under the device framework whether it is marketed for a medical purpose or a purely aesthetic one. It is not regulated as a cosmetic or a medicine. Article 1(6) sets the test for borderline products: the product's "principal mode of action" decides whether it is a medicine or a device. For example, a filler that contains a supporting medicinal substance does not become a medicine for that reason alone.

Cosmetics and "skin booster" products

The Cosmetic Products Regulation (Official Gazette, 8 May 2023, No. 32184, repeat issue) defines a cosmetic product. It is a substance or mixture applied to the external parts of the body (skin, hair, nails, lips and so on), or to the teeth and oral mucosa. Its sole or main purpose is to clean, perfume, change appearance, protect or keep those parts in good condition. Article 2 expressly excludes anything intended to be swallowed, inhaled, injected or implanted.

So an "exosome" or "skin booster" product labelled as a cosmetic is, legally, meant for application to the skin. Another product sold under a similar name may have been placed on the market as a device. The name tells you little; the label and the legal framework matter. Ask the treating physician.

CE marking and notified bodies

Article 3 of the Medical Device Regulation defines the CE mark. It is the mark by which the manufacturer indicates that the device conforms to the applicable requirements. Article 20 sets out how the mark is used:

• The mark is affixed before the device is placed on the market. It goes on the device or its sterile packaging, and it must be visible, legible and indelible. It also appears in the instructions for use and on the sales packaging.
• Where a notified body was involved in the conformity assessment, its identification number follows the CE mark.

A notified body is an independent conformity assessment body designated under the regulation. The European Commission lists the notified bodies designated under the MDR in its NANDO information system. According to the Commission, information on certificates that notified bodies issue, suspend or withdraw is public in the EUDAMED Notified Bodies and Certificates module. Use of this module has been mandatory since 28 May 2026.

A CE mark is not a blanket approval for a whole product category. It applies to a specific device from a specific manufacturer, for the intended purpose that manufacturer has declared. Two brands of the same kind of device, or two models from the same brand, can have different status.

The Product Tracking System (ÜTS): what it shows and what it doesn't

Article 34 of the regulation requires economic operators, notified bodies, healthcare facilities and healthcare professionals in Türkiye to meet their obligations under the national Product Tracking System (ÜTS). According to TİTCK's ÜTS page, medical devices placed on the market and their related documents have been registered through ÜTS since 12 June 2017. One of the system's stated aims is to allow citizens to query products. The user agreement on the same page says the ÜTS mobile app can look up information on medical devices, cosmetics and biocidal products, either by camera scan or by typing in the product number.

A query can show you whether a product number is registered, along with basic information on the registered product. On its own, a ÜTS query does not prove:

• That the unit used on you is genuine. Barcodes and codes can be copied, a risk TİTCK has flagged explicitly for medicine codes.
• That the product is appropriate for your treatment area or indication.
• That the person and the place are authorised to perform the procedure.

Treat a ÜTS record as one piece of evidence, alongside the packaging, lot number, expiry date and an open conversation with the physician.

What does "FDA approved" mean?

"FDA approved" describes a product's regulatory status in the United States. It does not replace licensing, CE marking or ÜTS registration in Türkiye. The U.S. Food and Drug Administration uses two different terms:

• Approval (PMA): According to the FDA, premarket approval is its scientific and regulatory review of the safety and effectiveness of Class III (high-risk) devices.
• Clearance (510(k)): A premarket notification showing that a device is substantially equivalent to a legally marketed device. The outcome is "clearance", not "approval".

FDA consumer guidance explains several further points. A drug is approved as safe and effective for its intended use. The FDA does not "approve" healthcare providers, physician offices or laboratories. Registering a facility or listing a product does not mean it has been approved. Cosmetic products and their labelling do not require FDA approval. So when you see "FDA approved", ask three questions: which product, which model, and for which intended use?

Who may perform procedures, and where?

The Regulation on Private Outpatient Diagnosis and Treatment Facilities (Official Gazette, 19 April 2025, No. 32875) addresses this in Article 6(10). Aesthetic or cosmetic health services may be provided within a medical centre, polyclinic or private physician's practice (muayenehane), provided the physical space and minimum equipment defined for a consultation room are in place. These services are provided by physicians, within competencies acquired through training curricula or certification, and within the medical procedures permitted at that facility. This guide does not interpret authority beyond that provision. Who may perform a specific procedure should be assessed against the applicable legislation and Ministry of Health rules.

Reading clinic websites: the advertising rules

The promotion of health services is governed by the Regulation on Promotion and Information Activities in Health Services (Official Gazette, 12 November 2025, No. 33075). It repealed the 2023 regulation of the same name (Article 13). The provisions most useful to a reader of a clinic website are these:

• Covert or overt advertising of health services is prohibited (Article 5(1)).
• Websites may not describe methods that are not scientifically and clinically proven or not established medical practice (Article 5(1)(ç)).
• Certificate-based "specialist" titles may not be used outside the specialties registered through a diploma (Article 5(1)(d)).
• Patient thank-you or satisfaction statements may not be used as advertising (Article 5(1)(e)).
• Research findings and statistics may not be presented in a way that leads to conclusions different from what they show (Article 5(1)(ğ)).
• No content may suggest that a device, product or service is superior to others, and no company, product or brand may be promoted (Article 5(1)(h)).
• Fees, discounts, campaigns or promotions may not be mentioned (Article 5(1)(m)).
• The regulation does not ban before-and-after images outright, but it attaches strict conditions. The patient must give explicit consent. Images must be taken under the same setting and technical conditions, with the procedure dates stated. They may not be edited afterwards. Comments and likes must be switched off. A warning must also be shown, stating that results of any surgical or interventional procedure vary from person to person and advising the reader to consult their physician in detail beforehand (Article 7).

This is why "guaranteed results", "the best product" or price-led campaigns on a website are a reason for caution.

A practical checklist for patients

Questions to ask before treatment

• The exact name of the product, and whether it is a medicine, a medical device or a cosmetic.
• The lot (batch) number and expiry date. You can ask for them to be recorded in your file.
• That the sealed, unopened packaging is opened in front of you.
• For a device, the manufacturer and exact model name. Models within the same product family can differ in CE scope and intended purpose.
• For CE-marked devices, the notified body number next to the mark.
• Who will perform the procedure, and in which licensed healthcare facility.

Red flags

• Syringes or vials that are unlabelled, pre-opened or pre-filled, or whose product name, lot number and expiry date cannot be read.
• Explanations such as "privately imported" or "obtained by hand". TİTCK states that licensed botulinum toxin should be supplied only through pharmaceutical warehouses.
• Prices far below the market.
• Promises of permanent or guaranteed results. The warning that the regulation makes mandatory states plainly that results vary from person to person.
• Procedures performed outside a healthcare facility, for example at home or in a hotel room.

If something goes wrong

For adverse reactions to medicines, TİTCK's 2024 letter points to the Turkish Pharmacovigilance Centre (TÜFAM). For incidents involving medical devices, TİTCK's Medical Device Vigilance Forms page provides reporting forms for healthcare facilities and manufacturers. If something unexpected happens, contact the treating physician and facility first, and ask them which reporting route applies.

Limits of this guide

This article is general information. It is not legal advice or personal medical advice. Regulations change. For current texts, rely on mevzuat.gov.tr, the Official Gazette and TİTCK. The status of a specific product or device should be confirmed directly with official sources and with the physician who will treat you. This text is based on sources accessed on 23 September 2026.

This guide is published on drhamzagemici.com as general information relating to the non-surgical medical aesthetic services provided by Dr. Hamza Gemici, M.D., in Ataşehir, Istanbul.