Regulatory Pathway for Hong Kong and China Medical Devices Entering Türkiye

Strategic Importance of the Turkish Medical Device Market

Türkiye represents a strategically significant medical device market, combining a large population with a regulatory framework that closely mirrors European Union legislation. However, market access is governed by strict procedural and documentary requirements. For medical devices manufactured in Hong Kong or China, successful entry into the Turkish market depends not only on product quality but also on full regulatory compliance, accurate documentation, and continuous post-registration maintenance.

Device Classification under EU-Aligned Regulations

The process begins with the correct classification of the medical device in accordance with European Union medical device regulations. The risk class of the device determines the applicable conformity assessment route and the scope of mandatory documentation. At this stage, the manufacturer must ensure that all regulatory documents are prepared in strict alignment with the determined class.

These documents typically include the Declaration of Conformity, the EC Certificate where applicable, product labelling, Instructions for Use, and technical or promotional materials. An incorrect classification or inconsistency between the device and its documentation will inevitably prevent market access in Türkiye.
Reference: EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Barcode and Traceability Requirements

Following classification, the product barcode structure must be established. In Türkiye, barcodes serve not merely a commercial function but also a regulatory and traceability purpose. The barcode data must be fully consistent with the product’s name, model, manufacturer details, and packaging configuration.

Any discrepancy identified during the registration process may result in rejection or delay, making accuracy at this stage essential. Barcode inconsistencies are among the most common technical issues identified during Product Tracking System reviews.

Appointment of a Local Distributor or Authorised Representative

A critical requirement for non-Turkish manufacturers is the appointment of a local distributor or authorised representative based in Türkiye. Manufacturers established outside the country cannot place medical devices on the Turkish market independently.

The appointed entity assumes legal responsibility for regulatory compliance, communication with the authorities, and fulfilment of post-market obligations. Selecting a partner with insufficient regulatory expertise frequently leads to long-term compliance issues and, in some cases, market withdrawal.
Reference: Turkish Medical Device Legislation aligned with EU MDR.

Mandatory Turkish Translation of Documentation

Once a local partner is appointed, all regulatory documentation must be translated into Turkish. This requirement is explicitly defined under Turkish medical device legislation. Translations must be medically precise, terminologically consistent, and fully aligned with the approved source documents.

Inadequate or machine-generated translations are a common cause of rejection and may trigger additional regulatory scrutiny.

Registration in the Product Tracking System (ÜTS)

The next stage involves registration within the national Product Tracking System. This system functions as the central regulatory database for all medical devices placed on the Turkish market.

Product details, manufacturer information, authorised representative data, and Turkish documentation are uploaded and verified through this platform. Without successful registration, the sale, distribution, or promotion of a medical device in Türkiye is strictly prohibited.
Reference: Turkish Product Tracking System (ÜTS) regulatory framework.

Post-Registration Obligations and Ongoing Compliance

Upon completion of the registration process, the product remains active in the system provided that no changes occur in the approved documentation. However, maintaining market presence is an ongoing obligation.

Any update related to product design, labelling, Instructions for Use, certificates, or manufacturer details must be promptly reflected in the system. Manufacturers and their representatives are also required to monitor official announcements and regulatory updates published through the Product Tracking System. Failure to maintain up-to-date records may result in suspension or removal from the market.

Continuous Compliance as a Market Requirement

Market entry in Türkiye is not a one-time administrative exercise but a continuous compliance process. Regulatory updates, system announcements, and documentation revisions require constant attention.

For manufacturers based in Hong Kong or China, language barriers and regulatory complexity significantly increase operational risk. As a result, many manufacturers rely on comprehensive local regulatory expertise combined with high-quality linguistic support to manage the entire lifecycle of their products in the Turkish market.

Conclusion

Türkiye offers substantial opportunities for Hong Kong- and China-based medical device manufacturers. However, success in this market requires precision, regulatory discipline, and reliable local support.

When device classification, documentation, translation, registration, and post-market maintenance are properly aligned, Türkiye can become a stable and sustainable growth market for international manufacturers seeking long-term regional expansion.(source: Medikoz Çeviri)