Are you selling, or planning to sell, medical devices or cosmetic products in Turkey? If so, the Product Tracking System, or ÜTS, is one of the most critical topics for you. This system, mandated by the Turkish Ministry of Health, ensures that every stage of a product’s journey, from the production line to the end-user, is tracked. So, how is the Product Tracking System (ÜTS) registration done? While this process may seem complex, it can be easily managed with the right steps. In this comprehensive guide prepared by MedikalKalite.com, you will find the answers to all your questions about the ÜTS registration processes.
What is the Product Tracking System (ÜTS) and Why is it Important?
The Product Tracking System (ÜTS) is a digital infrastructure that monitors the production, import, distribution, and end-user delivery processes of all medical devices and cosmetic products offered on the Turkish market. The primary goal of the system is to protect public health, maximize patient safety, and prevent the circulation of unsafe or counterfeit products in the market.
If you are a manufacturer, importer, dealer, or healthcare service provider, registering with ÜTS is a legal obligation. Without registration, you cannot place your products on the market, sell them, or receive reimbursement.
ÜTS Registration Processes: Where Should I Start?
The ÜTS registration process consists of two main steps: Company Registration and Product Registration. We can almost hear you asking, “So, how exactly do I complete these steps?” Let’s examine the process step by step.
Step 1: Company Registration (Firma Kaydı)
First and foremost, your company must be introduced to the system. The ÜTS company registration is your gateway into the system.
- Who Needs to Register?: All stakeholders in the sector, such as manufacturers, importers, dealers, optician’s establishments, and hospitals.
- What are the Requirements?: For company registration, you will generally need your MERSİS (Central Registration System) number, tax number, and the Electronic Signature (E-Signature) or Mobile Signature of an authorized person.
- Frequently Asked Question: “Do I need to register separately for my branches in different locations?” Yes, you may need to register and activate your headquarters and each of your branches separately in the system.
Step 2: Product Notification and Registration (Ürün Bildirimi ve Kaydı)
After successfully registering your company, the next step is to declare the products you offer to the market. This is the stage that requires the most attention and expertise.
- What Information is Required?: Critical technical documents and information such as the product’s class, brand, model, barcode (GTIN), intended use, Declaration of Conformity, and EC Certificate must be entered into the system completely and accurately.
- Frequently Asked Question: “What should I pay attention to when uploading my product documents to the system?” It is critically important that the documents are up-to-date, complete, and in the correct format. Even a small mistake, especially in product classification or document naming, can lead to the rejection of your application.
Challenges Encountered in the ÜTS Process and the Importance of Professional Support
The ÜTS registration process can involve more detail and technical knowledge than it appears. Many companies lose time and resources dealing with questions like:
- “Why is my ÜTS application constantly being rejected?”
- “I can’t figure out which document to upload where; the system is very complicated.”
- “How can I be sure that I have classified my medical device correctly?”
- “Can I manage this process on my own without making mistakes?”
This is precisely where Medikal Kalite Consultancy comes in. With years of experience, we eliminate all the complexity of the ÜTS registration processes for you.
How We at MedikalKalite.com Help You
We manage the ÜTS registration process for you in a fast, seamless, and reliable manner.
- Complete Document Preparation: We check all your necessary technical documents, identify any deficiencies, and prepare them for submission.
- Correct Application Management: We carry out your company and product registrations in full compliance with the system’s requirements.
- Process Tracking and Finalization: We monitor every stage of your application on your behalf, taking swift action in case of potential rejections or deficiencies to complete the process as quickly as possible.
- Consultancy and Training: We inform you about the process and provide guidance for your future operations.
Focus your time and energy on your core business. Let us take on the entire burden of your ÜTS registration processes.
Contact us to get detailed information about our ÜTS registration and consultancy services and to start the process today!
