ÜTS Individual Movement Notifications

MEDICAL DEVICE PRODUCT TRACKING SYSTEM INDIVIDUAL MOVEMENT NOTIFICATIONS

Determines the procedures and principles for implementing the individual tracking processes for medical devices.

This includes the procedures and principles to be followed in the Product Tracking System (UTS) for individual tracking of products from the production/import process to their delivery to the end user.

2017/745 Medical Device Regulation

2017/746 Regulation on In Vitro Medical Diagnostic Devices

Medical Device Sales, Advertising, and Promotion Regulation

TİTCK: Turkish Medicines and Medical Devices Agency

SGK: Social Security Institution

System: Product Tracking System

MERSİS: Central Registry System

VEDOP: Tax Offices Full Automation Project

ESY: Electronic Process Management

ÇKYS: Core Resource Management System

SUT: Health Implementation Communiqué

GTİP: Customs Tariff Statistics Position

GMDN: Global Medical Devices Nomenclature

MEDULA: An integrated system established between general health insurance and healthcare facilities to electronically collect invoice information and process payment for services without interfering with the facilities' internal processes.

YUPASS: Overseas Provision Activation and Health System,

Dealer: A natural or legal entity within the supply chain, other than the manufacturer or importer, that makes a device available on the market until it is put into service,

Unique Identifier: A code within the product QR code that includes product-specific information such as the product number, serial/lot number, and production/expiration dates,

Corrective Action: An action taken to eliminate the cause of a potential or existing nonconformity or other undesirable situation.

Defining the Individual Product in the System

Individual-Based Tracking

(1) Medical devices are tracked by serial and/or lot number according to the manufacturing process determined by the manufacturer.

(2) Tracking medical devices by serial number indicates that there is only one individual product with the same individual number.

(3) Tracking medical devices by lot number indicates that there is more than one individual product with the same individual number.

(4) Products tracked by both serial and lot numbers are tracked by serial number in the system.

(5) Different production and expiration dates are not allowed in the system for products with the same product number and lot number.

(6) The primary product number of the medical device or the market release barcode added to the primary product number may be used in product movement notifications for medical devices registered on the ÜTS.

(7) Only production/import/import/export notifications can be made using the market supply barcode. In the case of a notification using the market supply barcode, individual product movements are made using the primary product number specified in the "internal quantity" section entered into the system when defining the market supply barcode.

Production Notification

(1) A "production notification" is made for products whose country of origin is "Turkey" in the product registration.

(2) The manufacturer only makes a production notification for medical devices that are registered on the ÜTS or that meet the requirements announced by the Agency under the transitional provisions of the Medical Device Regulation.

(3) When making a Production Notification, following selection from the product list, data must be entered in the following fields:

· Lot and/or serial number

· Quantity information when only the lot number is entered

· Production date or expiration date

(4) For products for which shelf life information is entered during product registration, if only the production date or expiration date is entered, the system will calculate the date field information not entered based on the shelf life.

(5) For products for which shelf life information is entered during product registration, if the production date and expiration date are entered during production notification, the system will not allow notifications with expiration dates exceeding the shelf life.

(6) If the Production Notification is submitted incorrectly, it is cancelled with a "Production Cancellation Notification." For products tracked by serial number, no other product movement notifications (such as a delivery notification) must have been issued. For products tracked by lot number, there must be an equal number of individual products in stock as the individual product included in the system with the production notification from the relevant lot number.

Import Notification

(1) An "import notification" is made for products whose country of origin does not include "Turkey" in the product record.

(2) If the country of origin includes another country in addition to "Turkey," a production or import notification can be made.

(3) Import notifications can be made by the importer, along with a dealer authorized by the importer.

(4) The importer or dealer authorized to issue import notifications can only make import notifications for medical devices registered on the ÜTS or that meet the requirements announced by the Agency under the transitional provisions of the Medical Device Regulation.

(5) When making an Import Notification, following a selection from the product list, data must be entered in the following fields:

· Lot and/or serial number

· Quantity information when only the lot number is entered

· Production date or Expiration date

· Country of import

· Country of origin

(6) For products with shelf life information entered during product registration in the system, if only the production date or expiration date is entered, the system will calculate the date field not entered according to the shelf life.

(7) For products with shelf life information entered during product registration in the system, if the production date and expiration date are entered during production notification, the system will not allow notifications with expiration dates exceeding the shelf life.

(8) If an Import Notification is submitted incorrectly, it can be cancelled with an Import Cancellation Notification. To be eligible for an import cancellation notification, products tracked by serial number must not have received any other product movement notifications (such as a delivery notification). For products tracked by lot number, there must be an equal number of individual products in stock from that lot number as there are individual products included in the system through a production notification.

Inventory Notification

(1) Healthcare providers and medical service providers submit inventory notifications to the ÜTS for fixed-rate medical devices subject to maintenance, repair, and calibration within their holdings.

(2) After querying the product number during the Inventory Notification, it is mandatory to enter the inventory acquisition date and serial number. Inventory notifications are not made using lot numbers.

(3) To submit an inventory notification, the product number must be known and identified on the ÜTS.

(4) If the product number has not been identified on the ÜTS, the product number information must first be retrieved from the previous registration system, the Turkish National Information Bank for Medicines and Medical Devices (TİTUBB), and then identified on the ÜTS.

(5) If an institution making an inventory notification has identified a product number on the ÜTS that is not already identified on the ÜTS, other healthcare service providers submit inventory notifications using the identified product numbers.

(6) If an Inventory Notification is submitted incorrectly, it can be cancelled with a Cancellation Notification. (7) Information on how to submit inventory notifications is included in Annex 1.

Movement of Individual Products in the System

Notification of Delivery

(1) A notification of delivery is made when individual products owned by an institution/company/hospital are intended to be delivered to another institution/company/hospital.

(2) If the addressee institution/company/hospital does not issue a notification of receipt in response to the notification of delivery, no stock transfer will be made for that product.

(3) When making a Notification of Delivery, after querying the product number, lot, and/or serial number, data must be entered in the fields:

· Quantity Supplied

· Institution

· Document Number

.

(4) When making a notification of delivery for products provided as free samples, the relevant field must be marked.

(5) When making a notification of delivery, any information such as an invoice number, delivery note number, report, etc. can be entered in the mandatory field: Document Number, which will facilitate communication/tracking between the notifying institution and the addressee.

(6) If the Delivery Notification was made incorrectly and no delivery notification has yet been issued, it will be canceled with a Delivery Cancellation Notification.

(7) If the addressee company/institution/hospital does not wish to receive the products for which a delivery notification has been issued, this product information can be viewed in the "My Delivery Notifications I Do Not Want to Receive" section, and the relevant delivery notifications can be canceled.

(8) Delivery notifications for which no delivery notification has been issued by the addressee company/institution/hospital can be viewed in the "My Pending Individual Products I Have Issued."

Receiving Notification

(1) A receiving notification is made to accept the delivery notifications made by the institution/company/hospital.

(2) For medical devices tracked by lot, a lesser quantity than the quantity specified in the delivery notification can be issued. In this case, the "received quantity" section can be updated to indicate an incomplete delivery notification.

(3) If an incomplete receipt notification is made, the individual product remaining in the inventory of the company/institution/hospital that submitted the notification will remain.

(4) If the Receipt Notification is made incorrectly, it cannot be canceled. To cancel the transaction, a repeat notification must be made to the company/institution/hospital that submitted the notification, and the relevant party must then receive the medical devices with the notification.

(5) If the products submitted with the notification are not intended for collection, the "I do not wish to receive" option must be selected. Product information can be accessed in the "Receipt Notifications I Do Not Wish to Receive" section. If the institution/company/hospital that submitted the notification has not yet canceled the delivery for the notification, the "Receipt Notification" option can be used again.

(6) The institution/company/hospital can respond to the delivery notifications received collectively using the "Receipt Notification Bulk" or "I Do Not Wish to Receive Bulk" sections.

System/Procedure Package (SIP) Single Notification Procedures

(1) Before submitting a production notification for medical devices registered as System/Procedure Package (SIP) on the ÜTS, a single notification of the subproducts identified in the SIP record must be submitted.

(2) A sufficient quantity of subproducts must be available at the time of the SIP production notification.

(3) The procedures for submitting an import notification for SIP-type medical devices are the same as for general medical device import notifications.

(4) Detailed information on how to submit a single notification for SIP-type medical devices is provided in Annex 2.

Individual Product System Removal

Notification of Use

(1) If a medical device is implanted in the body by a healthcare provider and/or is covered by reimbursement and must be directly linked to the patient, a "Notification of Use" is made for that product using personally identifiable patient information.

(2) To submit a notification of use for a medical device, the following must be registered on the ÜTS:

· The question "Can it be implanted?" must be answered "yes."

· One of the questions "Is it for single use?" or "Is the product used for a limited number of times?" must be answered "yes." The "SUT Match Status" option must be selected as "SUT match."

· The question "Can it be used on a single patient?" must be answered "yes."

(3) When submitting a Usage Notification, following a query using the product number, lot, and/or serial number, data must be entered in the fields:

· Number of Uses

· Date of Use

· Patient/Consumer Name and Surname

· Identity Information Type

(4) The Identity Information Type field allows you to enter the following information: Turkish Identity Number, Foreign Identity Number, Passport Number, YUPASS Number, and Neonatal Information.

(5) When entering patient information in the Usage Notification field:

· If the patient is a citizen of the Republic of Turkey, enter the Turkish Identity Number, Patient Name, and Patient Surname.

· If the patient is a foreign national and has a foreign identity number, enter the Foreign Identity Number, Patient Name, and Patient Surname.

· If the patient is a foreign national and does not have a foreign identity number, enter the Passport Number, Patient Name, and Patient Surname.

· If a YUPASS number is available, enter the YUPASS number, Patient Name, and Patient Surname.

· If the patient is a newborn (if they do not yet have a Turkish Republic ID number), enter the patient's name and surname. Select "yes" for the "Newborn question" and enter the relevant ID number in the "Personal Identifier Number" field based on the mother's ID type.

· If the patient is an unidentified patient, enter "unidentified" in the first-last-name field, select "Identity Type" as "Unknown", and enter any number, such as a case file number, opened by the healthcare facility for that patient in the "Personal Identifier Number" field.

(6) If the Usage Notification was made incorrectly, it will be canceled with a "Use Cancellation Notification." However, if the confirmation process was made in MEDULA after the usage notification was made, the confirmation process in MEDULA must first be canceled, and then the usage notification in ÜTS must be canceled.

(7) For products invoiced to MEDULA with surface area (cm2, etc.) information, the usage notification in ÜTS is made on a per-unit basis.

(8) For products with a "Number of Products in Content" entry greater than "1" in the product registration, usage notifications can be made up to the number of products in the product registration.

(9) For products with limited usage, usage notifications can be made up to the "Number of Limited Uses" entry in the product registration.

(10) For medical devices deemed necessary by the company or healthcare provider to require a usage notification, the Institution may define a usage notification in the ÜTS upon request.

Consumption Notification

(1) If a product is used for which a usage notification is not required by the healthcare provider, a "Consumption Notification" is made for these products.

(2) To make a consumption notification for a medical device, when registering the product on the ÜTS, the following must be true:

· The question "Can it be implanted?" must be answered "no."

· One of the questions "Is it for single use?" or "Does the product have a limited number of uses?" must be answered "yes."

· The option "No SUT Match" must be selected for the "SUT Match Status."

(3) When making a Consumption Notification, following a query using the product number, lot, and/or serial number, data must be entered in the following fields:

· Quantity Consumed

· Consumption Date.

(4) For medical devices deemed to require a consumption notification by the company or healthcare provider, the Institution may define a consumption notification on the ÜTS upon request.

Consumer Delivery Notification

(1) A "Consumer Delivery Notification" is made for medical devices sold directly to consumers by the sales center.

(2) When making a Consumer Delivery Notification, after querying the product number, lot, and/or serial number, data must be entered in the fields:

· Quantity Dispensed

· Date Dispensed

(3) When a Consumer Delivery Notification is requested to be sent to consumers using their identification information:

· Patient/Consumer Name and Surname

· Identity Information Type

(4) In the Identity Information Type field, select one of the following options: Turkish Identity Number, Foreign Identity Number, Passport Number, or YUPASS Number, and enter the identity information number in the relevant field.

(5) When entering patient information in the Consumer Delivery Notification field:

· If the patient is a citizen of the Republic of Turkey, enter the Turkish Identity Number, Patient Name, and Patient Surname.

· If the patient is a foreign national and has a foreign identification number: Foreign Identification Number, Patient Name, and Patient Surname are entered.

· If the patient is a foreign national and does not have a foreign identification number, enter the Passport Number, Patient Name, and Patient Surname.

· If a YUPASS number is available, enter the YUPASS number, Patient Name, and Patient Surname.

(6) If the Consumer Delivery Notification was incorrectly issued, it will be canceled with a "Consumer Delivery Cancellation Notification."

(7) When a medical device sold directly to a consumer by the sales center with a Consumer Delivery Notification is requested to be returned, a "Consumer Return Notification" is issued for the number of products to be returned.

HEK / Loss Notification

(1) A HEK / Loss Notification is issued by the institution/company/hospital for individual products that have reached the end of their useful life or are lost.

(2) When making a Loss Report, after querying the product number, lot, and/or serial number, data must be entered in the following fields:

· Lost Quantity

· Lost Type

· Loss Type

(3) When making a Loss Report, in the Loss Type field, select the appropriate option:

· Loss

· Natural Disaster

· Fire

· Theft

· Stock Adjustment

· Other (if selected, a description must be entered)

(4) If the Loss Report was submitted incorrectly, it can be cancelled by submitting a "Loss Cancellation Notification".

Notification of Delivery to an Undefined Place on the ÜTS

(1) A "Notification of Delivery to an Undefined Place" is made for medical devices sold to a place that cannot be defined on the ÜTS (shopping mall, airport, etc.).

(2) When making a Notification of Delivery to an Undefined Place on the ÜTS, after querying the product number, lot, and/or serial number, data must be entered in the fields:

· Tax Identification Number

· Document Number

· Quantity provided.

(3) If the Notification of Delivery to an Undefined Place was made incorrectly, it is cancelled with a "Notification of Delivery to an Undefined Place Cancellation."

(4) When a product sold with a Notification of Delivery to an Undefined Place is requested to be returned, a "Notification of Return from an Undefined Place" is made for the number of products to be returned.

Export Notification

(1) An "Export Notification" is made for individual products exported by the company.

(2) When submitting an Export Notification on the ÜTS, after a query using the product number, lot, and/or serial number, data must be entered in the following fields:

· Customs Declaration Number

· Quantity Information

(3) If the Export Notification is submitted incorrectly, it is cancelled with an "Export Cancellation Notification."

Product Recall Procedures

Notification of Withdrawal

(1) A recall decision is made by TİTCK or the manufacturer/importer who placed the product on the market for a product deemed unsuitable for use. Individual products subject to a recall decision are only referred to the relevant institutions for corrective action or for refusal to be re-entered into the market with a "Notification of Withdrawal."

(2) The notification of withdrawal cannot be used for individual products subject to a recall decision.

(3) After a query using the product number, serial, and/or lot number, data must be entered in the following fields:

· Quantity Issued

· Institution

· Document Number

(4) If the recall notification is submitted incorrectly, it can be cancelled with a "Recall Cancellation Notification."

Recall Notification

(1) A "Recall Notification" is issued by the institution/company to accept individual products issued with a recall notification.

(2) When submitting a recall notification, the received quantity information field for the medical device is defined as a mandatory field, and the number of products is automatically assigned to the number of units issued.

(3) No new production/import notifications can be made for the lot number for which a recall decision has been made.

Other Notifications

Temporary Release Notification

(1) A "Temporary Release Notification" is issued for individual products temporarily issued to a patient by the institution/company/hospital.

(2) When submitting a temporary release notification, after querying the product number, serial number, and/or lot number;

· Quantity Supplied

· Temporary Use Date

· Patient/Consumer Information

Data must be entered in the fields.

(3) In the ID Information Type field, you can enter the Turkish ID Number, Foreign ID Number, Passport Number, YUPASS (Overseas Provision Activation and Health System) Number, and information about the newborn. If the identity is known and other information is entered in the description field, a temporary use notification is made.

(4) When entering patient information in the Temporary Use Notification field:

· If the patient is a citizen of the Republic of Turkey, enter the Turkish ID Number, Patient Name, and Patient Surname.

· If the patient is a foreign national and has a foreign ID Number, enter the Foreign ID Number, Patient Name, and Patient Surname.

· If the patient is a foreign national and does not have a foreign ID Number, enter the Passport Number, Patient Name, and Patient Surname.

· If the patient has a YUPASS number, enter the YUPASS number, Patient Name, and Patient Surname.

If the patient is a newborn (does not yet have a Turkish Republic ID number), enter the patient's first and last names. If the "Newborn" question is selected as "yes," the relevant ID number is entered in the "Personal Identifier Number" field based on the mother's ID type.

If the patient is an unidentified patient, enter "Unidentified" in the first and last names field, select "Identity Type" as "Unknown." Any number, such as a case file number, may be entered for the patient by the healthcare facility in the "Personal Identifier Number" field. (5) If the Temporary Release for Use Notification was issued incorrectly, it is cancelled with a "Temporary Release for Use Cancellation Notification."

(6) If a product provided to a patient under a Temporary Release for Use Notification is intended to be returned, a "Removal for Use Notification" is issued.

Destruction/Disposal Notification

(1) If products are identified that pose a risk to patient or user health when used, a "Destruction/Disposal Notification" is made to remove these individual products from the system.

(2) When making a Destruction/Disposal notification, following a query using the product number, serial number, and/or lot number, data must be entered in the following fields:

· Quantity Destroyed/Disposed

· Reason for Destruction/Disposal

· Destruction/Disposal Document Number

When making a Destruction/Disposal notification, one of the following must be selected from the Reason for Destruction/Disposal field:

· Institutional Decision

· Voluntary Recall

· Expired

· Counterfeit/Illegal

· Transport and Storage Conditions Compromised

· Removed from the Patient's Body

· Other (if selected, a description is required)

(4) If the destruction/disposal notification was made incorrectly, it will be canceled with a "Destruction/Disposal Cancellation Notification."

Reprocessing Notification

(1) If an institution/company uses a single product defined in the ÜTS as a raw material in the production of another single product, it will issue a reprocessing notification.

(2) When submitting a reprocessing notification, it is mandatory to enter data in the "Quantity to be Processed" field after querying the product number, serial and/or lot number.

(3) If the reprocessing notification was made incorrectly, it will be canceled with a "Reprocessing Cancellation Notification."

Remedial Corrective Action

(1) A "Remedial/Corrective Action Notification" is issued for the rehabilitation or corrective actions that should be implemented on the product in accordance with the institution/company's identified nonconformity.

(2) The Remedial/Corrective Action Notification can be applied to all products, regardless of the decision to recall them.

(3) Products subject to recall orders will not be allowed back on the market without a Remedial/Corrective Action Notification.

(4) Product movement notifications will not be affected by Remedial/Corrective Actions for products not subject to recall orders.

Return to Country of Origin Notification

(1) An importer submits a Return to Country of Origin Notification when returning an imported individual product.

(2) When submitting a Return to Country of Origin Notification, following a query using the product number, lot, or serial number, data must be entered in the following fields:

· Quantity Issued

· Customs Declaration Number

If the Return to Country of Origin Notification was submitted erroneously, it can be canceled with a "Return to Country of Origin Cancellation Notification."

Final Provisions

Notifications that Can Be Made by Inactive Companies

(1) If a company with an inactive company status is an active user on its user list;

· Notification of Disposal

· Notification of Withdrawal

· Notification of Withdrawal

· Notification of Withdrawal

· Notification of Decommissioning

· Notification of Loss/Loss

· Notification of Destruction/Disposal

· Notification of Return to Origin

· All cancellation notifications can be made. Other notifications cannot be made.

(2) The movement of individual products in closed/transferred/merged companies is ensured through notifications of Disposal.

Notifications that Can Be Made for Products with Recall Decisions

(1) For medical devices with a recall decision, the following procedures can be performed:

· Issuance of Withdrawal and Cancellation,

· Receiving of Withdrawal,

· Corrective Action and Cancellation,

· Destruction/Disposal and Cancellation,

· Removal from the Patient's Body and Cancellation,

· Receiving of Return from Consumer and Cancellation,

· Removal from Use and Cancellation.

Notifications for Expired Products

(1) For medical devices that have expired or reached the end of their shelf life, the following can be made:

· Notification for issuing a recall notification

· Notification for receiving a recall notification

· Destruction/Disposal Notification. Other notifications cannot be made.

Notifications for Market Placement Barcodes

(1) The manufacturer may place the same product on the market with different market place barcodes, including different quantities.

(2) Separate product registration is not required for market place barcodes containing one or more items of a product registered on the ÜTS. In such cases, market place barcodes should be added as market place barcodes to the "market place information" section of the registered product, and the number of products in the "number of products in" section should be entered as the number of products registered on the ÜTS.

(3) When a product movement is made using the market supply barcode on the ÜTS, the system will allow the movement of products equal to the number of products registered on the ÜTS within the market supply barcode.

(4) The following can be made using the market supply barcode:

· Production/Import/Export Notification

· Export/Import Notification

Notifications other than those listed above cannot be made.

Bulk Notification with Excel

(1) Companies wishing to make a Bulk Notification with Excel must complete the updated Template File on the ÜTS in accordance with the information pages in the template and upload it to the system.

(2) The Excel template must be uploaded to the system without any modifications (without deleting any columns, rows, or pages).

(3) The Fields tab in the template provides information on the formatting of the fields.

Detailed Inquiry Fields

(1) An institution/company/hospital can query all its notifications using the "Notification Inquiry" section under the "Detailed Inquiry" menu, either by entering various criteria and filtering them or by entering no criteria at all.

(2) An institution/company/hospital can query all its individual products using the "Individual Product Inquiry" section under the "Detailed Inquiry" menu, either by entering various criteria and filtering them or by entering no criteria at all.

(3) By clicking the "Export My Individual Products to Excel" button on the Individual Product Inquiry screen, all individual product information will be emailed to you within the day.

(4) Inquiries made under the "Detailed Inquiry" menu do not include transactions made within the last hour. Transactions made within one hour can be viewed at the beginning of the next hour.

Manufacturer/Importer Individual Product Inquiry

(1) Manufacturer/importer companies can view their individual products, both those currently in the system and those that have been removed from the system, through the "Manufacturer/Importer Individual Product Inquiry" menu.

(2) Inadvertently incorrectly entered production and expiration dates for individual products can be updated in the "Individual Products in the System" section.

Medical Service Provider Notification Procedures

(1) Companies that provide services to healthcare providers in imaging, laboratory, dialysis, etc. through methods such as in exchange for consumables/kits or results must be registered on the ÜTS as a Medical Service Provider.

(2) The procedures that medical service providers must perform on the ÜTS are listed in Annex 3.