On 16 June 2017, the Turkish Medicine and Medical Device Institution ("Institution") published the Draft Regulation on the Registration, Traceability and Tracking of Medical Devices ("Draft Regulation") on its website.
The Draft Regulation provides certain principles regarding the tracking system for medical devices, which is described in Article 4 as "the online system which allows the registration, traceability and tracking of products in the scope of the Medical Device Regulation, the Regulation on Active Implantable Medical Devices, and the Regulation on In Vitro Diagnostic Medical Devices, and which is used for registration procedures regarding legal or real persons that manufacture, import, export and sell these products, importers' real or legal person representatives, if any, and institutions." In a nutshell, the system revolves around the registration and notification obligations of the manufacturers and importers and, in return, the recording obligations of the Institution.
The main issues and subjects addressed under the Draft Regulation are as follows:
- Notification and Recording
As per Article 5 of the Regulation, titled "General Principles," the Institution is responsible for keeping all kinds of records related to medical devices, including records related to the sale of such medical devices, as well as information and records concerning real or legal persons and their representatives who manufacture, import, export, sell, distribute, or repair medical devices.
For this purpose, the Institution collects information, records and documents from manufacturers (or, if the manufacturers reside outside of Turkey, from their representatives) regarding their company and their medical devices. If such documents expire and are not renewed in due time, then these records /registries are put on hold (i.e., suspended) by the Institution, and the registration of new devices governed by these documents is prohibited, and production/importation notifications are also not allowed.
This system also functions as a hub for manufacturers who wish to connect with potential dealers for the distribution of their registered devices. Such direct connections between manufacturers and dealers are not subject to the Institution's approval and do not require its consent.
Article 6 of the Draft Regulation sets forth the registration requirements. According to Article 6, the following requirements should be fulfilled when seeking registration: (i) real or legal persons should be engaged in commercial activities, (ii) system users should possess an electronic or mobile signature, and (iii) information and documents that may be requested by the Institution as per the guidelines (to be published) should be procured and submitted to the Institution.
Information and documents regarding medical devices that are requested by the Institution will also be uploaded to the registration system and will be available for all users to see, in line with the principles that will be explained and detailed under the Institution's guideline(s). To that end, users will have to ensure that such information and documents are kept up-to-date at all times.
- Principles as to Traceability and Tracking
Principles regarding the traceability and tracking of medical devices are set forth and regulated under Article 7 of the Draft Regulation.
Article 7 specifies that the guiding principle is to trace and track medical devices beginning from their introduction to the market and continuing until the end of their commercial life cycle. In this regard, importers, manufacturers and related parties should notify the Institution about the importation, production and transfer/movements of medical devices, in accordance with the Institution's soon-to-be-published and future guidelines.
Article 7 indicates that the Institution will also prepare guidelines with respect to notification requirements regarding medical devices' usage processes, surveillance, auditing and warning systems for medical devices, as well as procedures relating to the traceability and tracking of medical devices.
Parties who fail to comply with the system requirements enumerated in the Draft Regulation will face certain sanctions, as listed in Article 9, which range from the suspension or cancellation of the company's registration to sanctions that are listed under the Law Regarding the Preparation and Application of the Technical Legislation on Products, which include administrative monetary fines up to TL 250,000 (approx. EUR 60,000).
This article was first published in Legal Insights Quarterly by ELIG, Attorneys-at-Law in September 2017. A link to the full Legal Insight Quarterly may be found here
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