UTS Registration Consultancy
What is UTS?
ÜTS is an abbreviation that stands for Product Tracking System. This abbreviation; On January 7, 2014, T.C. It is used for the Product Tracking System Project signed between the Ministry of Health, Turkish Medicines and Medical Devices Agency (TİTCK) and TÜBİTAK-BİLGEM-YTE (Software Technologies Research Institute).
What is the Product Tracking System Project?
Product Tracking System (ÜTS) Project; It is an e-government application that provides citizen-oriented services and has hundreds of thousands of users. With this project; It is aimed to develop a system that will provide an infrastructure to track all medical devices and cosmetic products produced or imported in our country, from the production line to the place where they are sold and used, and to the patient. As it is known, the originality of the medicines and cosmetic products used is of great importance for human health. For this reason, tracking the products and registering the products are the processes that can be applied to access the original products.
The aims of the project;
• Contributing to ensuring patient safety,
• To ensure the traceability of medical devices and cosmetic products,
• To create an infrastructure that will ensure the healthy and effective execution of audit services,
• To create an infrastructure that will enable the administration to take quick measures against the dangers that may arise during the use of medical devices and cosmetic products,
• Contributing to the prevention of the informal economy by monitoring medical devices and cosmetic products,
The expected gains to be achieved with the commencement of the Product Tracking System (ÜTS) Project;
• Establishing a medical device map of Turkey through the existing inventory, facilitating the identification of needs, procurement and transfer of products,
• Monitoring the calibration and maintenance/repair processes of all medical devices across the country through a single system,
• Identification and recall of old and defective products,
• Controlling the entry and movement of medical devices and cosmetic products into the country,
• Monitoring demand and consumption levels throughout the country,
• Ensuring brand safety,
• Protection of privilege and commercial rights in terms of dealer and branch relations,
• Preventing unfair competition of unqualified and counterfeit products,
Modules of the Product Tracking System (ÜTS) Project
Modules of the Product Tracking System (ÜTS) Project;
• Tracking and Monitoring (Product movements and product recall module),
• Product Management (BOM management and product management module),
• User, Institution and Authorization Management (user management, institution management and authorization management module),
• Clinical Engineering Management (Maintenance and repair management, calibration management, technical personnel certification module, etc.),
• Business Intelligence (Pre-defined reporting, map supported reporting module),
• Market Surveillance and Inspection (PGD) and Warning (Inspection activities and warning module),
• Supporting Functions (Document and certificate management, reference fields management, log management, announcement, scheduled tasks module),
• Citizen-Oriented Services (Product inquiry, registered product inquiry, complaint notification, maintenance and calibration inquiry module),
UTS Registration Consultancy
As of 12 June 2017, medical device registration/notification transactions, product movements and other related works and transactions are tracked via ÜTS. Consultancy services are provided by some consultancy firms in our country in the transactions related to the Product Tracking System. These processes can be expressed as ÜTS Registration Consultancy. Services provided within the scope of consultancy;
• Medical Device Sales Center Authorization Certificate: With the Medical Device Sales, Advertisement and Promotion Regulation, which entered into force on May 15, 2014, businesses that sell medical devices are required to obtain a certificate of authorization to continue their activities. Businesses wishing to obtain a certificate of authorization must fulfill certain conditions. ÜTS company registration procedures cannot be performed for companies that do not receive this authorization certificate. Also; In order to work as a responsible manager, sales and promotion staff, and clinical support staff in medical device businesses, it is necessary to take the trainings in TCESIS, pass the exam successfully, and apply to the Turkish Medicines and Medical Devices Agency to obtain the qualification certificate.
• Company Registration: Registration in the ÜTS system is required for medical device manufacturers (local manufacturers), importers and dealer companies. In order for the company to be registered, a medical device authorization certificate must be obtained.
• Document Registration: After the company is approved in the system, the documents required to be registered to the ÜTS regarding the medical devices to be registered in the system;
o Declaration of Conformity (It is a document prepared by the manufacturer.),
o EC Certificate (It is a document issued by a Notified Body.),
o User Manual (The product´s the definition is a guide.)
• After the documents are approved, you need to prepare for Ka ÜTS, the product from the book collection. As a target for data target in PDF format of Turkish tags, in addition to entering the registration process related to the process in the online process.
• Free sales from ÜTS are not made for products that are not freely sold or are not suitable for importation.
• Completion of approval in ÜTS, which is Social Security Institution (SGK) SGK reimbursement, SUT´s estimated SGK plans need to be completed.
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