What is Single Product Tracking System?
Before moving on to the main topic, let’s take a look at what the Product Tracking System (PTS) is.
PTS (Product Tracking System) is a system developed by TÜBİTAK to track and trace each product in the production line of all medical and cosmetic equipment, materials and products produced within the borders of Turkey or imported from abroad, from the factory to the end user. This system makes it easier to detect counterfeit products.
We should not pass without looking at the history of PTS. Single product tracking system was opened in 2016 for cosmetic product company registration, user process and product notification processes. Profiles and device/material inspection processes of all medical device companies were implemented with the system, which was opened for use by medical device companies in 2017. In 2019, the unique follow-up of blood glucose meters and insulin needles began. In 2020, singular tracking of all Type I, Type II and Type III products started throughout Turkey.
PTS portal can be easily accessed at https://utsuygulama.saglik.gov.tr/UTS/vatandas. Developed by TÜBİTAK BİLGEM, PTS can also be used by downloading the application (Android and IOS) from a mobile phone.
What is PTS used for?
- While keeping a medical device registration in Turkey
- While providing the infrastructure for the follow-up of the products in question
- While ensuring the protection of public health and patient safety
- While ensuring the effectiveness of the control
- Acting quickly against medical device issues
- While preventing the use of untrusted products in Turkey
What documents do you need to register for PTS?
PTS registration of every company that sells medical devices is clearly regulated in the relevant legislation. For PTS companies, the registration process must be done through MESİS or VEDOP. If your company has MERSIS and VEDOP numbers, you can do all your transactions through the MERSIS system. After the company is approved by the system, the necessary documents for medical device documentation registration must be uploaded to the system. These documents are:
- CE Apostille Certificate
- Announcement of eligibility
- User guide
- Authorized distributor certificate if you are not a manufacturer
- Certification of your quality management system
- If it is a domestic product, the document is for the national product.
- Product label (current)
- Packing sample
Registration to the Product Tracking System is made by uploading the above documents to the system. You will also be asked for other information that needs to be entered into the system. These:
- Name of the product
- Product brands
- Product line
- Origin information
- How many pens does it contain?
- Production or import information
- Relevant class information
- Category code
- Reference Code
- Code GMDN
- Product images
- Additional Notes
Application and Certificate
Export certificate (free sales certificate) is also issued with PTS. Medical Device Regulation No. 93/42/EEC, Active Implant Medical Device Regulation No. 90/385/EEC and 98/Free- Marketing Certificate A, No. 79/EC for the trademarks registered to the Turkish Medicines and Medical Devices Agency in the production facilities of domestic manufacturers in our country Issued for products covered by the in vitro diagnostic medical devices regulation. A free sale certificate is not issued for products that are not covered by the Medical Device Regulation.
The application is made as follows:
As stated on the website of the Ministry of Agriculture and Forestry, “The request regarding the application is attached to the application of the producer/exporter or its authorized representative; It is made in the provincial/district directorate with an authorized stamped and signed document containing the manufacturer company, approval/registration number, brand, trade name of the product, storage conditions, product description and product ingredient list.
If certification is requested for more than one product produced by the same manufacturer, the exporter fills the attached list in 2 copies and submits it to the Provincial/District Command with the registration request.
PTS Single Tracking
Now, let’s give information about our main subject. As you know; As of 12 June 2017, medical device registration/notification transactions, product movements and other related works and transactions are tracked through the Product Tracking System (PTS). From 1 March 2019, individual monitoring procedures will apply for medical devices.
As of the publication date, it is obligatory to make product movement declarations (invoice/export, usage, etc.) at PTS for products and devices with individual entries, medical devices, and products whose single transition has not started as of October. 31.2019 cannot be used in the provision of health services.
In addition, in order for the individual monitoring workflows to work properly, the health service providers (hospitals, practices, dialysis centers, medical centers, etc.) signed on the PTS must be reported to the Medical Devices Agency and the relevant authorities to the Provincial Health Directorate. In addition, medical equipment sales and distribution companies (medical device sales centers, eye clinics, hearing centers, optional orthopedic-prosthetic centers, prosthetic laboratories), dentistry, pharmacies, pharmacy warehouses, etc.)
It is necessary to check whether the person who does not sell or distribute the device has a criminal record. What is required for a single follow-up? “production notifications” from companies if they are manufacturers; The importer must make an “import notification”. Companies that have completed their production and import notifications can start making “give/receive” notifications for their sales as of March 1st.
The information you need for production and import notification is as follows:
- Your medical equipment
- Barcode number
- Party number
- Inventory Quantity (How many items are in stock as of March 1)
- Expiration date
- Recommended actions for single tracking
Based on the information above, we find it helpful to count the items in your inventory. Also, it is useful to record the sales you made after March 1, so there is no problem with your delivery notification.
When making the delivery announcement, you will need the barcode number of the medical device you are selling and the batch number of the medical device. You can create individual tracking messages (import messages, production notifications, export/receive messages, etc.) for your medical devices manually via single product tracking system or with the included Excel template.
What is the Purpose of Single Tracking?
- For the licensing of medical and cosmetic devices in Turkey,
- To create an infrastructure to monitor these products,
- To protect patient safety and to contribute to the protection of public health,
- To ensure that the audits are carried out correctly and efficiently,
- To ensure that measures are taken against product hazards,
Ensure that dangerous products are quickly removed from the market and stopped. Production, import, distribution and sale of products/devices in the range of medical devices for in vitro use, active implantable medical devices and medical diagnostic devices in the product tracking system; Registration/notification procedures are carried out for companies and organizations.
Benefits of P.T.S. to the company;
As of January 1, 2020, the product tracking system has been made mandatory for all companies selling, producing, importing and exporting medical products by the Ministry of Health. Meg Bilişim ve Yazılım has developed PTS software that can work seamlessly with most accounting and production programs to meet your needs in the field.
In order to facilitate your work, we enable you to inform TS about the documents you have entered, integrated with the enterprise resource planning (ERP) program you are currently using. With the Product Tracking System, you do not need to enter each product information when receiving cargo and notifications. Since it is integrated with your accounting program (ERP), product information is removed from your accounting program, preventing time and data wastage. It is a web-based system. When you import or export unknown messages, you can create public messages instead of creating individual messages.
You can see a report on your export notifications, so you can clearly see which products were donated when, to whom or from whom.