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Recent Developments in the Healthcare Sector – 5 August 2021

Legal Alerts
Covid-19
Healthcare
General

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The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK“) has published announcements on the implementation of the Medical Device Regulation and the normalization process following the COVID-19 pandemic.

Turkey Publishes New Announcement concerning the Transaction Period of the Medical Device Regulation

Recent Development

On 6 July 2021, the TİTCK have published a new announcement on their website. The announcement contains guidance for the convenience assessment during the transactional period of the new Regulation on Medical Devices (“Regulation“). The announcement is available here (in Turkish).

What’s New?

As per the new Regulation, the list of products that must be brought to approved organizations during the convenience assessment period has been extended. These products may be placed on the market under certain conditions until 26 May 2024. Their registration on the Product Tracking System (ÜTS) will remain valid if they update their status on the ÜTS by 26 August 2021. Failure to do so may cause the ÜTS registration to be terminated.

TİTCK Publishes an Announcement Concerning the Post-Pandemic Normalization Period

Recent Development

The TİTCK published an announcement concerning the update to their document, “The Precautions to Adopt in Clinical Trials against the COVID-19 Pandemic” on 19 July 2021. The relevant update aims to moderate the precautions adopted against the pandemic during the normalization period. The document is available here (in Turkish).

What’s New?

The TİTCK’s document, “The Precautions to Adopt in Clinical Trials against the COVID-19 Pandemic,” which was published on 20 March 2020, has been revised for the normalization period and certain precautions have been abandoned. Accordingly, the precaution to submit only electronic documents for initial applications and for ongoing clinical trials has been cancelled and as of 17 July 2021, physical documents must be submitted when required. Moreover, further rules for submission of physical documents to the TİTCK concerning the applications made between 20 March 2020 and 17 July 2021 will be announced by the TİTCK.

Conclusion

The TİTCK continues to provide guidance for companies working in the medical industry. Companies should carefully review the TİTCK’s announcements and take the necessary actions to ensure compliance.