The Turkish Ministry of Health has issued an announcement regarding the update of medical device company title and address information in ÜTS and EBS. The announcement states that due to outdated and inaccurate title and address information, problems have arisen during the delivery process of documents to medical device companies. As a result, these documents have been returned to the ministry.

In order to avoid these problems, the ministry is requiring medical device companies to update their title and address information in ÜTS and EBS by August 31, 2023. The applicant company is responsible for any problems that may arise due to discrepancies in title and address information in ÜTS and EBS.

To update the title and address information in ÜTS, the respective company must apply to the Provincial/District Health Directorate where it is registered. If necessary, the company may also need to apply to the authorized institution responsible for MERSİS or VEDOP information updates according to the company's registration type.

For updating the title and address information in EBS, the respective company must follow the provisions stated in the "Company User Guide" available at the web address ebs.titck.gov.tr. Regardless of whether the title and address information in EBS is up-to-date or not, companies that do not have a Registered Electronic Mail (KEP) Integration Address in EBS, even though they have a KEP address, must register their KEP address in EBS.

Starting from August 31, 2023, the physical documents that have been returned to the ministry will be sent back to the respective medical device companies as a one-time process. If the re-sent documents are returned to the ministry again due to outdated and inaccurate title and address information or for any other reason, these documents will be archived and, in accordance with the ministry's archiving procedure, will be destroyed when the time comes.

The ministry has urged medical device companies to update their title and address information as soon as possible to avoid any delays in the delivery of documents or the processing of applications.

Impact of the announcement

The announcement is likely to have a significant impact on medical device companies in Turkey. By requiring companies to update their title and address information, the ministry is aiming to ensure that documents are delivered to the correct addresses and that applications are processed more efficiently. This will ultimately benefit both companies and patients.

However, the announcement may also create some challenges for companies. For example, companies may need to update their title and address information in several different systems, which can be a time-consuming and complex process. Additionally, companies that do not have a KEP address may need to obtain one, which can also be a challenge.

Overall, the announcement is a positive step by the ministry to improve the efficiency of the medical device regulatory system in Turkey. However, companies should be aware of the challenges involved in updating their title and address information and should start the process as soon as possible.

Recommendations

In order to comply with the announcement, medical device companies should take the following steps:

* Update their title and address information in ÜTS.
* Update their title and address information in EBS.
* Register their KEP address in EBS, if they do not already have one.
* Start the process of updating their title and address information as soon as possible.

By taking these steps, companies can ensure that they are in compliance with the announcement and that they can continue to operate smoothly.