The new article provides additional clarifications regarding certain specific regulatory aspects, including the applicability of the marketing legislation.
Table of content
The Turkish regulating authority in the sphere of medical devices has published a guidance document dedicated to the implementation of the regulation on the sale, advertising, and promotion of medical devices. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. The authority also reverses the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
In particular, the document outlines the regulations governing the technical service obligations and warranty provisions related to medical devices. The aim is to ensure that manufacturers and importers provide consistent and reliable support for medical devices throughout their lifecycle, in compliance with the relevant legislation.
Technical Service
Article 17 of the regulation addresses the responsibilities of sales centers, particularly manufacturers and importers, in providing technical services for medical devices and their accessories. It emphasizes the importance of ensuring technical support for healthcare providers and outlines specific steps for compliance.
- Technical Service Obligations: Sales centers, as manufacturers or importers, must fulfill their technical service obligations as per the Regulation on Technical Service of Medical Devices, published in May 2023. This regulation ensures that devices used in healthcare services receive adequate technical support.
- Commitment to Technical Service: Sales centers must register their commitment to provide technical service for devices and accessories in the Product Tracking System (ÜTS) throughout the device’s lifecycle. Failure to register this commitment by January 1, 2025, will result in the inability to register the device in ÜTS.
- Devices Registered Before January 1, 2025: For devices registered in ÜTS before January 1, 2025, manufacturers and importers must provide technical service throughout the device’s lifespan in accordance with the relevant legislation. If a sales center does not meet these requirements by March 31, 2025, their registration will be deactivated.
- Ongoing Compliance: After January 1, 2025, manufacturers or importers must register their commitment to providing technical service for any devices listed in the relevant Guide within three months of the device’s inclusion. Failure to do so will result in the device’s registration being dropped from ÜTS.
- Registration Process: Sales centers must follow the specified process for recording their commitment to technical service in ÜTS. This can be done either during the initial company registration or afterward.
- Provision of Technical Information: Sales centers must provide any passwords or similar access information needed for technical service, free of charge, within 24 hours of a healthcare provider’s request. This ensures timely support for devices in use.
Warranty Provisions
Article 18 outlines the warranty requirements for medical devices and their accessories, ensuring that healthcare providers have clear and enforceable rights regarding the warranty period and conditions.
- Warranty Rights for Healthcare Providers: If a healthcare provider opts for a device replacement under warranty, the sales center has 45 days to comply. However, if the replacement would cause disproportionate difficulties for the sales center, this period may be extended to 180 days, subject to approval by the relevant institution.
- No Separate Warranty for Accessories: A separate warranty certificate for device accessories is not required if they are included in the device’s warranty certificate.
- Digital Warranty Certificate: Warranty certificates can be provided digitally via text message, email, or other electronic formats as long as the healthcare provider can review, copy, and access the information without modification.
- Start of Warranty Period: The warranty period begins on the date of the invoice, which is issued after the healthcare provider accepts the device. If the invoice is issued before acceptance due to a commercial contract or alternative financing model, the warranty period still starts from the device acceptance date.
- Inclusion of Usage Period: Warranty certificates must specify the usage period defined in the Regulation’s “Definitions” section, particularly under subparagraph (cc) of Article 4.
Final Provisions, Entry into Force, and Execution
The final chapter of the document provides additional regulations regarding device sales, updates to the registration process, and the guidelines’ entry into force and execution.
Article 19 outlines additional conditions related to the sale and registration of medical devices:
- Restrictions on Sales: Sales centers are prohibited from selling devices not listed in Annex-3 of the Regulation to entities that are not registered in ÜTS, with specific exceptions, such as central units of the Ministry of Health, the Ministry of National Defense, municipalities, and other specified organizations.
- Authorization Requirements for Certain Entities: Entities registered in ÜTS as manufacturers or importers of devices included in Annex-3 of the Regulation must obtain a medical device sales center authorization certificate by May 26, 2024. Failure to do so will result in the deactivation of their ÜTS registration.
- Mandatory Registration for Non-Listed Entities: Entities not registered as manufacturers or importers of the devices listed in Annex-3 as of May 26, 2023, must obtain a sales center authorization certificate to register their devices.
- Company Record Requirements: Sales centers must include their official website’s home page URL and social media account addresses in their company records in ÜTS. This requirement becomes mandatory after June 30, 2024, and the information must be kept up to date.
Repeal of Previous Guidelines
Article 20 repeals the previous version of the guide, titled “Guide on the Implementation of the Medical Devices, Sales, Advertisement and Promotion Regulation (2nd Version)”, which was approved on January 9, 2024.
Conclusion
IIn summary, the guidance focuses on ensuring that manufacturers and importers meet their technical service obligations and provide reliable warranty coverage for medical devices. The document also provides guidelines for the registration and compliance of sales centers in the ÜTS system, ensuring that all technical and warranty services meet the standards outlined in the relevant regulations; and also reinforces the need for adherence to these regulations and sets clear expectations for the sales and registration of medical devices in the healthcare market.
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