介绍
In today’s rapidly evolving healthcare landscape, the medical device industry is growing significantly in response to technological advancements and increasing public health needs. However, manufacturers wishing to operate in this field must not only comply with technical standards but also meet stringent regulatory requirements. Among these, obtaining a CE certificate and completing the licensing processes required by the Turkish Ministry of Health are essential legal prerequisites for market access.
This article addresses the legal framework surrounding the CE marking process and Ministry of Health permissionsfor manufacturers who intend to market medical devices in Türkiye.
1. What is CE Certification and Why is it Necessary?
The CE mark (Conformité Européenne) signifies that a product complies with European Union (EU) regulations and is eligible for free circulation within the European Economic Area. Türkiye, as part of the EU–Turkey Customs Union, has aligned its medical device regulations with the EU framework.
For medical devices, CE certification is governed by the following regulations:
- Directive 93/42/EEC on Medical Devices (MDD) – (now repealed)
- Regulation (EU) 2017/745 on Medical Devices (MDR) – (currently in force)
To obtain CE certification, manufacturers must:
- Determine the device’s risk classification (Class I, IIa, IIb, III),
- Complete conformity assessment procedures,
- Prepare a comprehensive technical file,
- Conduct a clinical evaluation and, if necessary, clinical investigations,
- Undergo audits by a Notified Body,
- Issue a Declaration of Conformity.
2. Ministry of Health Procedures and Registration in Türkiye
Medical devices intended for manufacturing, import, or sale in Türkiye are regulated by the Turkish Medicines and Medical Devices Agency (TİTCK) under the Ministry of Health. Manufacturers must fulfill the following legal requirements:
🔹 Product Tracking System (ÜTS) Registration
- Devices cannot be marketed without registration in the Ürün Takip Sistemi (ÜTS).
- CE certification and the Declaration of Conformity are prerequisites for registration.
- The manufacturer, importer, or authorized distributor must be registered in the system.
🔹 Company Notification and Authorization
- Companies must register with the TİTCK and be authorized under appropriate activity codes.
- Appointment of a qualified technical personnel is mandatory.
🔹 Advertising and Promotion Restrictions
- Medical device advertising is subject to strict Ministry regulations.
- Misleading claims, unauthorized health declarations, and unverified efficacy assertions are subject to legal penalties.
3. Legal Sanctions and Enforcement
Medical devices placed on the market without CE marking or ÜTS registration may be subject to:
- 行政罚款,
- Product recalls,
- Sales bans and license revocations.
Moreover, using a fraudulent CE certificate may constitute a criminal offense under Turkish Penal Code provisions on forgery of official documents.
4. Legal Recommendations for Manufacturers
- The CE certification process should be managed with professional regulatory consultancy.
- TİTCK records must be accurate and up to date.
- Technical documentation, clinical data, and test reports should be stored in an auditable format.
- Contracts with distributors must clearly outline responsibilities, liability, and data-sharing procedures.
结论
For medical device manufacturers, CE certification and Ministry of Health registration are not just legal formalities—they are critical to ensuring product safety, protecting public health, and maintaining commercial credibility. Failure to comply with these obligations may result in serious legal and financial consequences.
📌 Any manufacturer or importer planning to enter the Turkish market must complete all conformity assessment steps, properly register with the ÜTS, and operate in full compliance with the applicable legal framework. Otherwise, products may be withdrawn from the market, and companies may face heavy sanctions.
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