Question 1

How to Login to ÜTS?

Accepted Answer

You can use various methods to log in to the ÜTS system. These include e-Government password, e-Signature, Mobile Signature and Internet Banking. You can also log in to ÜTS securely with e-Signature or Mobile Signature.

Question 2

How to Use Electronic Signature in ÜTS?

Accepted Answer

When you need to sign a document electronically on ÜTS, you can easily sign using your e-signature card. This process ensures that your documents are approved securely and quickly.

Question 3

I Receive a "Select Certificate" Warning When Signing an Application with My e-Signature Card, What Should I Do?

Accepted Answer

If you receive a "Select Certificate" warning when signing an application using your e-signature card, you need to check if the necessary e-signature drivers are installed on your computer. In order for your e-signature card to work properly, first make sure that the card is plugged into your computer. Then, you can verify that the drivers are working properly by logging in to turkiye.gov.tr ​​with your electronic signature. If you cannot log in, you may need to contact your e-signature card service provider.

Question 4

How Are Users Defined in the Healthcare Provider Registry and How to Define New Users?

Accepted Answer

When registering a health service provider in ÜTS, users for Public Hospitals, Provincial Health Directorates, District Health Directorates, clinics and polyclinics are automatically drawn from ÇKYS (Employee and Institution Management System). Users defined on behalf of the institution in ÇKYS are also reflected in ÜTS thanks to system integration.
In order to define a new user, a user definition must be made on behalf of the relevant institution via ÇKYS. Since this process is integrated into the ÇKYS system, user information will be automatically transferred to ÜTS. For private hospitals, user definitions are made by the hospital manager from the User → User Account Transactions menu.

Question 5

How will the newly registered documents on ÜTS be numbered?

Accepted Answer

When assigning numbers to newly registered documents to the ÜTS system, the company numbers will be transferred as 2667269xxxxxx as in the TİTUBB system. This numbering will be created by adding the last 7 digits of the 13-digit company number to the document number to be created on ÜTS. For example, this number will be arranged as 9xxxxxx-UB1.

Question 6

How can I re-register products if my document is rejected?

Accepted Answer

• First, the document that the products are associated with must be registered. If there is a new document to associate with the products, this document must also be registered.
 • The products to be updated are selected by entering the document number on the List My Medical Devices screen.
 • Listed products are saved via e-mail by selecting the "Matching Criteria" option from the "Export to Excel" button.
 • The document number field in the incoming zip file is updated if it is desired to be associated with a new document.
 • If you do not want to update the visual and label fields of the products, these fields are deleted from the Excel file.
 • Draft medical devices are created in bulk using the prepared Excel file by selecting the Add Bulk Medical Device option from the Add button on the Medical Device Notifications screen.
 • Finally, an application is created from the Medical Device Application process and the draft products are sent to TITCK for review.

Question 7

How to Correct an Error in a Document Application Requiring Physical Documents?

Accepted Answer

1. A document number can only be used once in a company; therefore, a new document with the same number cannot be added.
2. The information in the document cannot be updated before the application is finalized or canceled.
   In this case, in order to update the document, the application must be canceled and the application must be made again. You can follow the steps below:
   1. The application detail is opened and the Cancel button is clicked to confirm.
   2. The system brings the application to the Canceled status and puts the document records in it in the Draft status.
   3. The necessary updates on the document are made and the application is created again.
   By following these steps, the error on the document can be corrected and a new application can be made.

Question 8

What Should I Do to Transfer My ÜTS Products to Excel?

Accepted Answer

1. Go to the List My Medical Devices page.
2. Click on the “Export All Medical Devices to Excel” button at the top right of the page.
3. With this process, you can transfer all your products to an Excel file in bulk .
The Excel file has been prepared to include all the information about your products and is also suitable for mass transfer operations to ÜTS.

Question 9

How to cancel the receipt notification on ÜTS?

Accepted Answer

There is no notification type called "Receiving Cancellation Notification" in ÜTS. In order to cancel the receiving notification, you must first return the products you have purchased to the company that gave you the products with a "Receiving Notification". Then, the other company must also receive these products again with a receiving notification.

Question 10

What does it mean for products that appear as "There is a Single Product in the System" on the Medical Device List screen on ÜTS?

Accepted Answer

When a product is registered with ÜTS, it is unique. If there is a decrease in the product registration for a reason that does not affect security, the registration status of that product will appear as “Unique Product in the System” on the Medical Device List screen. Healthcare providers will not experience any problems when purchasing in this situation. This issue has also been clarified in the Circular No. 2019/19 on Procurement of Goods and Services Related to Medical Devices.

Question 11

The company/institution to which I made a notification did not accept the notification by selecting the "I Do Not Want to Receive" option. What should I do?

Accepted Answer

In order to cancel the transaction for a company/institution that has selected the "I Do Not Want to Receive" option on ÜTS, you must follow these steps:
1-In ÜTS, go to Product Movements → Delivery/Receiving Notification → My Delivery Notifications That You Do Not Want to Receive.
2-The relevant notification must be selected and the "Issuance Cancellation Notification" transaction must be completed.
Without this transaction, a new issuance notification cannot be made for the same product.

Question 12

I want to select the “I Do Not Want to Receive” option for notifications sent to me in bulk, what should I do?

Accepted Answer

In order to select the “I Do Not Want to Receive” option for notifications sent to you in bulk on ÜTS, you can follow these steps:
 • Go to the Export/Receive Notification → I Don't Want to Receive in Bulk screen.
 • Here, you can select the bulk of the notifications sent to you and select the "I Do Not Want to Receive Bulk" option.

Question 13

What do the "Seen" and "Not Seen" fields on the missing receipt notifications screen mean?

Accepted Answer

The “Seen” and “Not Seen” fields on the incomplete receipt notifications screen on ÜTS are explained as follows:
 • Incomplete Receiving Notification: If there is a difference between the delivery notification made by you and the number of products received by the other company, this situation is recorded as an Incomplete Receiving Notification.
 • “Seen”: When you select this option, you indicate that you are aware of the incomplete receipt notification and that you have reviewed this notification.
 • “Not Seen”: This option indicates products whose incomplete receipt notification you have not yet reviewed and are not aware of. 
   These fields have been developed to make it easier for you to follow up on incomplete receipt notifications and to keep your notifications under control.

Question 14

Which document number should be entered in the document number field when making a submission notification in ÜTS?

Accepted Answer

During the delivery notification on ÜTS, companies can enter any document number such as invoice, delivery note, etc. in the document number field in order to facilitate communication and tracking in mutual medical device delivery and delivery transactions.
This field is used only to support communication between companies and there is no official control or verification of the document number entered on the ÜTS system.

Question 15

What type of notification should be used when making a notification to cosmetic companies for medical devices?

Accepted Answer

When making a notification of delivery to cosmetic companies for medical devices on ÜTS, the "Notify Cosmetic Company Delivery" option should be used.
An institution number has been created for companies registered as cosmetic companies on ÜTS. Therefore, this notification type should be selected when making a medical device delivery transaction.
After this transaction, there is no need for the other party to make a separate receiving notification on ÜTS.

Question 16

We are giving free products to hospitals for promotional purposes, will we make notifications for these?

Accepted Answer

Yes, since the location of physical products is tracked on ÜTS, a delivery notification must be made via ÜTS for products given free of charge for promotional purposes.
During the delivery notification, the question "Free Sample?" must be answered "Yes" and the transaction must be carried out.

Question 17

The other party has made a notification of incomplete receipt for the products for which I have made a notification of delivery. In this case, what should I do for the products that have not been received?

Accepted Answer

If the other party does not make a notification of receipt for the products for which a delivery notification is made on ÜTS, the number of products not received continues to remain in the ÜTS stocks of the company making the delivery notification.
Incomplete delivery notifications can be viewed on the Product Movements → Delivery/Receiving Notification → Incomplete Delivery Notifications screen.
If the other party has made an incomplete delivery notification inadvertently, a new delivery notification can be made on ÜTS for the products not received.

Question 18

I want to make a bulk notification of receipt for the notifications of delivery made to me, what should I do?

Accepted Answer

If you want to make a bulk receiving notification for the delivery notifications made to you on ÜTS, you can use the Product Movements → Delivery/Receiving Notification → Bulk Receiving Notification screen.
You can make a bulk receiving notification for the products you select on this screen.

Question 19

I have transferred my company, how will the individual products I own be transferred?

Accepted Answer

Even if your company's status is passive in ÜTS, individual products in your stocks can be transferred to the relevant parties by making a delivery notification through the ÜTS system via active users registered in the company.
Thanks to this process, product movements in your ÜTS records are managed correctly.

Question 20

We notified the hospital to give, and they notified to take, but then we realized that the medical device was wrong. What do we do?

Accepted Answer

In ÜTS, product handover transactions between two companies/institutions are carried out only through delivery and receipt notifications.
In this case, the party that made the wrong delivery notification will make a delivery notification to the place where they received the product and you will receive this product back with a delivery notification.
Then, you will need to deliver the correct product to the correct place by making a new delivery notification via ÜTS.

Question 21

What will happen if the other party does not make a notification of receipt after making a notification of giving in ÜTS?

Accepted Answer

As long as a notification of receipt is not made on ÜTS, the individual product will continue to remain in the stock of the party making the notification of delivery. There is no time limit for this situation, i.e. the suspended products will be counted in the inventory of the party making the notification of delivery on ÜTS until the notification of receipt is made.

Question 22

What notification should I use when returning consignment items to the hospital?

Accepted Answer

All handover transactions in ÜTS are made with a delivery notification and a receiving notification. These notifications should also be used for consignment products. However, at which stage they will be used depends on the relationship between the manufacturer/importer company and the healthcare service provider.
As follows:
 • The manufacturer/importer company delivers the consignment products to the healthcare service provider, but no notification is made via ÜTS. After the operation, it is clear which products are used and a delivery notification is made to the healthcare service provider for these products and a receiving notification is made by the healthcare service provider. Then, an invoice is issued.
 • Another option is that a delivery notification is made (also via ÜTS) for all consignment products at the very beginning and the healthcare service provider also makes a receiving notification. After the operation, the healthcare service provider makes a delivery notification for the products used and returns the consignment products to the company.

Question 23

While making the production/import declaration, the quantity of products we have in stock was entered less. What should we do?

Accepted Answer

If you have entered a missing product quantity while making a Production/Import notification via ÜTS, you can make a new Production/Import notification with the same product information (product number, lot number, production date) to complete the missing quantity.
For example; you were initially planning to import 15 units, but you only made a notification with 10 units in the first notification. When you realize your mistake, you can make a new notification of 5 units with the same information and add the missing 5 units. With this process, you will have a total of 15 units in stock by adding them to the old quantity.

Question 24

When making the production/import notification, more products were entered than the quantity we have on hand. What should we do?

Accepted Answer

If, after making the production/import declaration , the quantity of the product you have entered is more than the quantity you have on hand, you can follow these steps:
1. If individual products are not moved :
    • You can cancel the notification from the Notification List/Cancel/Return screen and make a new notification with the correct amount.

1. If individual products are moved :
    • For the excess amount, you can select the relevant individual product from the Product Movements → Delivery to Consumer/Usage/Other Notifications screen and make a "DAM/Loss Notification" for the excess amount.
    • In this process, do not forget to select the HEK/Casualty Type Information field as "Stock Adjustment" .

Question 25

I entered the production/expiration date incorrectly when making the production/import declaration. How can I correct the date information?

Accepted Answer

Manufacturer/importer companies can follow these steps to correct date information:
1. Go to Product Movements → Manufacturer/Importer Individual Product Query → Individual Products in the System screen.
2. Inquire with product number and serial/lot number.
3. You can update the production/expiration dates of all individual products of the relevant product.

Question 26

How to declare production for System/Process packages?

Accepted Answer

To declare production for a system/operation package, you can follow these steps: 
1. The individual products that make up the system/process package must be in your stock.
2. When making a production notification, you must select individual products from your current stock.
3. Individual products that are automatically added to the system/process package are deducted from your stock and the system/process package is created in your stock.

Question 27

When making a usage notification, I receive the error "Notification cannot be made because the individual product does not meet the usage notification conditions." What should I do?

Accepted Answer

The reason you are getting this error is that the individual product does not meet certain conditions that are suitable for the use notification. In order to make a use notification, the following conditions must be met:
1. If the product is for single use and has a SUT match, use can be made.
2. If the product is for limited use and has a SUT match, use can be made.
3. If the product is not for single use or limited use, use can be made only if the "Can it be used for a single patient?" field of the product is "Yes".
4. If the "Can it be implanted in the body?" field of the product is "Yes", use can be made.
If the product does not meet these conditions, but you think it should be used, you can report the situation to TİTCK and request a check.

Question 28

How can I cancel the usage notification after the finalization process is done in MEDULA?

Accepted Answer

First of all, the finalization process made in MEDULA must be canceled through SGK services. Then, the usage notification must be canceled on ÜTS.

Question 29

When I notify MEDULA about my usage notification on ÜTS, I receive an error message stating that the personal identification information does not match. What should I do?

Accepted Answer

When reporting usage on ÜTS, the type of personal identity information entered must be the same as the type of personal identity information entered on the MEDULA screens.
For example, if you reported on ÜTS with your Turkish Republic ID number, you will get an error if you try to report on MEDULA with YUPASS. In this case, you must report on ÜTS with YUPASS.

Question 30

Why do I get the warning "Usage notification cannot be made for products with unlimited usage numbers" when I want to make a usage report?

Accepted Answer

The reason you are getting this warning is because the question "Single Use?" is answered as no in the medical device information, which means the product is multi-use. Then, the question "Is There a Limited Number of Uses?" is asked, and if "Number of uses is unlimited" is marked, then a usage notification cannot be made for multi-use products. Therefore, you get this error.

Question 31

When I want to “Finalize ÜTS” the usage notification I made on ÜTS in MEDULA, I receive the error message “Notification must be active”, what should I do?

Accepted Answer

This error message occurs because the notification code used during the “ÜTS Finalization” process in MEDULA does not belong to an active notification in ÜTS. You can follow these steps to correct this situation:
1. Check the notification code used in finalization with the usage notification code made in ÜTS.
2. The notification in question may have been canceled or a code belonging to the wrong notification type may have been sent.
If the notification is not active, you will first need to process the notification that needs to be activated.

Question 32

When I want to make the "ÜTS Finalization" transaction in MEDULA for the usage notification I made in ÜTS, the quantity in the ÜTS usage notification does not match the quantity information in the service. I receive an error message, what should I do?

Accepted Answer

This error occurs because the quantity in the ÜTS usage notification does not match the quantity information in the service record in MEDULA. This situation can occur especially due to calculations related to the surface area information of the product.
Solution steps:
1. Product surface area information: The manufacturer or importer adds the surface area information of the product when registering the product. This surface area information is used by the SGK when making calculations for the finalization of the UTS usage.
2. Make a calculation: When performing the ÜTS Finalization process via MEDULA, check that the difference between the quantity in the usage notification in ÜTS and the quantity in the service record is due to multiplication by the surface area of ​​the product. For example:
    • If the product surface area is entered as 3.25 cm² and 5 product uses are reported:
    • Calculation: You need to calculate 5 pieces * 3.25 cm² = 16.25 cm².

1. HBYS Programmers: To perform this calculation automatically, HBYS programmers receive the surface area information of the product to be notified from ÜTS via services and send it to MEDULA by multiplying the surface area by the number of notifications entered by the user.
In this way, the quantity in the ÜTS usage notification can be matched with the quantity information in MEDULA.

Question 33

I am receiving an error saying "The product does not meet the consumption notification conditions." How can I remove the product from the system?

Accepted Answer

This error occurs because the products do not meet the consumption notification conditions in the system. The product exit notification in ÜTS is determined according to the recorded product information. In this case, you must follow the steps below to ensure the exit of the product:
1. Check Product Conditions:
 • Single-Use Product: If the product is single-use and there is no SUT match, it can be consumed.
 • Limited Use Product: If the product is limited use and there is no SUT match, consumption is possible.
   2. Create a Request Notification for Product Release:
 • In ÜTS, you must create a request by adding a descriptive text about the product and sample barcodes to the request notification field.
3. Institutional Evaluation:
 • The request made to ÜTS is evaluated by TİTCK. As a result of the evaluation, the institution defines an appropriate process regarding the consumption or usage notification.
 • As a result of the definition made by the institution, products can be removed from the system.
   By following these steps, you can ensure that the necessary action is taken to exit your products from the system.

Question 34

Will a Consumer Delivery Notification be made to ÜTS for optical individual products given to citizens in return for a prescription?

Accepted Answer

The process for prescription optical single products is as follows:
1. Production and Importation Notification: After the product has gone through the production or importation process, these notifications must be made to ÜTS.
2. Issuance and Receiving Notification: After the product is given to healthcare service providers such as hospitals or pharmacies, a Issuance Notification and, if necessary, a Receiving Notification must be made on ÜTS.
However, after these products are given to the consumer (citizen), a “Consumer Delivery Notification” or “Consumer Return Notification” is not required to be made to ÜTS. This process will be done through MEDULA. In the ÜTS system, this stage is considered to have been given to the consumer and no additional notification is made.

Question 35

When I want to make a notification of giving to an undefined place on ÜTS, I receive the error "It is not possible to give to an undefined place to a company registered on ÜTS", what should I do?

Accepted Answer

This error occurs when an attempt is made to make a notification of delivery to an undefined place on ÜTS. The term undefined place refers to places that are not registered on ÜTS and where medical devices are not sold.
 • An undefined place delivery notification is generally required for places that are not registered on ÜTS. For example, notifications are made for medical device sales in places such as markets, shopping malls, airports.
 • However, a “Delivery Notification” must be made for medical device sales made to companies or healthcare service providers registered on ÜTS. In this case, you do not need to make a notification of delivery to an undefined place, because the transaction is already being made to a registered company.
Solution: Make sure that the place you are making a notification of delivery to is registered on ÜTS. If it is not registered and you are trying to make a notification of delivery to an undefined place by mistake, you should make the transaction through the correct company or healthcare service provider.

Question 36

I want to make an inventory notification but I cannot find the product in the system, what should I do?

Accepted Answer

If you cannot find the product you want to declare inventory for in the system, you can follow the steps below:
1. If the product is registered in ÜTS: You can make a notification from the Product Movements → Inventory Notification field.
2. If the product is registered in TİTUBB: The product must be brought from TİTUBB from the Medical Device → Inventory Product List field. Then, an inventory notification can be made as if it were a product registered in ÜTS.
3. If the Product is Not Registered in Both TİTUBB and ÜTS: Since a method has not yet been developed for such products, notification is not expected.
If the product still cannot be found after these steps, you can request a solution by reporting the situation to the relevant units.

Question 37

How is it decided whether a product will be tracked as a lot or a series?

Accepted Answer

This question explains how the serial or lot-based tracking of products is determined in relation to ÜTS. The manufacturer or importer determines how the product will be tracked, and this decision is shaped by the way the product is placed on the market. TİTCK determines whether the product will be tracked or not, but the choice of tracking method (serial or lot) is at the discretion of the manufacturer or importer.
In this case, when you need to make a decision about the tracking method of your product, you should consider the production and distribution process of the product.

Question 38

Can we see where any product is at any given time?

Accepted Answer

Through ÜTS, the location and movement status of individual products can be tracked by companies to a certain extent. However, you can only see the next point where they delivered the individual product. While manufacturing and importing companies can instantly see which company or institution the product is in, they cannot obtain information about other points the product has passed through in the past. In other words, it is not possible to track all past movements of the product.

Question 39

How are product registration and unique notification procedures carried out in cases where there are different product numbers (barcodes) on both the outer packaging and the packaging of the products in the package for medical devices placed on the market in multiple packages?

Accepted Answer

​In cases where medical devices placed on the market in multiple packages have different product numbers (barcodes) on both the outer packaging and the inner packaging, product registration and unique notification procedures should be carried out as follows:​
1. Recording Product Numbers in the System: When registering a product to ÜTS, all barcode numbers of the product (for example, barcodes obtained from standards such as GS1, HIBC, ICCBBA) must be entered into the system. If there are two separate barcodes obtained from different standards for the same product, these barcodes must be recorded in the system as "primary" and "secondary" product numbers.
2. Determination of Packaging Information: Barcodes on the outer and inner packaging of the product are important to ensure traceability of the product. Information such as the product name, pharmaceutical form, expiration date and batch number should be included on the outer packaging of the product or on the inner packaging if there is no outer packaging.
3. Product Tracking and Notifications: In all notifications made via ÜTS, it should be determined which barcode of the product will be used and consistency should be ensured. If there are different barcodes on the outer and inner packaging of the product, it should be clarified which barcode will be used in which notifications.
For detailed information and application steps, you can refer to the relevant announcement of the Ministry of Health.

Question 40

How will the individual notification of medical devices placed on the market together with human medicinal products be carried out?

Accepted Answer

The Product Tracking System (ÜTS) registration and individual notification processes of medical devices that are placed on the market and used together within the scope of the Human Medicinal Products Regulation vary depending on the nature of the product and its intended use. For detailed information, you can refer to the announcement numbered 2019/ÜTSG-11 of the Turkish Medicines and Medical Devices Agency.​UBBMED+2

Question 41

When I want to cancel the delivery notification, the "Cancel" button does not appear. What is the reason?

Accepted Answer

If the other party has made a receiving notification for the given delivery notification, the "Cancel" button will not appear. All handover transactions in ÜTS are made with the Delivery/Receiving Notification. In this case, you must contact the other party for the incorrect notification and make a new delivery notification for the relevant products to be returned to you.

Question 42

Although my notification can be viewed on the "Notification List/Cancellation/Refund" screen, it cannot be viewed on the "Detailed Inquiry" screens. What is the reason?

Accepted Answer

Detailed Query screens have been created to facilitate reporting and listing. Notifications are transferred to these screens at periodic intervals. However, due to possible problems in transfer, instant data may sometimes not be displayed on these screens. In this case, you can use notification screens such as "List/Cancel/Return" or "Notify Delivery" to instantly query your notifications and individual products. These inconsistencies are detected by the technical team and updated over time.

Question 43

I can't make notifications with Excel. What is the reason?

Accepted Answer

The reason you cannot make a notification with Excel is that the template used is not up to date or there is missing/incorrect data entry. You need to download the current Excel template again from the Product Transactions → Mass Notification with Excel section. It is important to carefully follow the information that guides you on the tabs on the template you downloaded. In this way, you can complete the notification process without any problems by entering the correct data.