GOUTS — Product Tracking System
GODATA produces serialization and aggregation solutions for medical device tracking system applications, regardless of medical product and device diversity. With our solutions, you can perform 2D code printing regardless of product shape and size, packaging type, create transport unit aggregation, and make receiving and giving notifications.
The Republic of Turkey, which has effectively used traceability systems since 2010, also attaches importance to medical device tracking system applications. The Turkish Medicines and Medical Devices Agency (TMMDA) uses the Product Tracking System (PTS) for the traceability of medical devices. TMMDA has shared details about the requirements and application process in the Guide on the Registration of Medical Devices to the Product Tracking System.
The Product Tracking System, also used as a medical device tracking system since 2017 alongside cosmetic products, allows medical device dealership and company searches through the PTS portal.
The primary purpose of PTS is to track the processes a product undergoes from domestic production or import to reaching the end user throughout the supply chain. With PTS, the traceability of insulin pen needle tips and blood sugar test strips started in 2019, and in 2020, traceability applications for all Class 1, 2, and 3 medical devices began.
As known, in line with the Medical Devices Regulation No. 2017/745 published on 25.05.2017 and entering into force on 26.05.2020, medical devices must have UDI-compliant QR codes or linear barcodes on the product when placed on the market.
With the 2019/PTSG-10 Postponement Announcement on Product Tracking System Unique Tracking Processes, it was announced that the unique tracking processes of other medical devices, except for Class III risk level medical devices and optical medical devices whose unique tracking process has already started, will become mandatory as of 01.01.2020.
Especially for medical devices sold directly to citizens, those with UDI-compliant QR codes or linear barcodes placed on the market as of 01.01.2020 will be preferred for easier management in distribution channels and more reliable and traceable reimbursement processes. In case these requirements are not met by the manufacturer of products imported from abroad, products can be placed on the market by importer companies in our country by printing UDI-compliant QR codes or linear barcodes on the box.
Regarding the term 'Organization' in the text of the relevant article, Article 115 (12) states, 'Until the Commission appoints issuing agencies pursuant to the second paragraph of Article 27, GS1, HIBCC, and ICCBBA are deemed to have been appointed as issuing agencies.'
In this context, on June 6, 2019, the European Commission published Commission Implementing Decision 2019/939 on 'Designation of Issuing Entities to Operate a System for the Assignment of Unique Device Identifiers (UDI) in the Field of Medical Devices' and appointed GS1 AISBL, Health Industry Business Communications Council (HIBCC), ICCBBA, and Informationsstelle für Arzneispezialitäten — IFA GmbH as organizations.
In this scope, primarily, you can access the issues related to QR code creation by considering the UDI guides of the GS1 AISBL organization, which will provide UDI assignment.
What do we offer within GOUTS?
Automation module that creates the barcoding infrastructure for solid and liquid products.
Process management that creates the box and pallet hierarchy for barcoded products.
Module that manages ministry-related processes such as Production, Sale, Sale Cancellation, Import, Export, Return, Transfer online or offline.
Module management that reprints SSCC barcodes for boxes and pallets if necessary after production.
Module consisting of AI-powered software that manages suspended product issues.
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