Life Sciences and Health Care

Introduction The Food and Drug Administration (FDA) has recently released new guidance on the enforcement policy for non-invasive remote monitoring … Read more

The Turkish Ministry of Health has announced that the Product Tracking System (PTS) will be implemented in accordance with the … Read more

The Turkish Ministry of Health has issued an announcement regarding the update of medical device company title and address information … Read more

The Turkish Medicine and Medical Devices Authority (TITCK) has updated a number of regulations in 2023. These updates are designed … Read more

The Turkish Medicines and Medical Devices Agency (“TITCK”) has published a Guide on Reliance Practices in Clinical Trial Applications (“Guide”) … Read more

The Turkish Medicines and Medical Devices Agency (“TITCK”) has published the Draft Medical Device Clinical Trials Regulation (“Draft Regulation”) on … Read more

The Turkish Ministry of Health (“Ministry”) has recently issued the Regulation on Telemedicine Services (“Regulation”), determines the procedures and principles … Read more

On November 16, 2021, the US Food and Drug Administration (“FDA”) authorized the marketing of EaseVRx, a prescription-use immersive virtual … Read more

The Regulation on Conformity Assessment Bodies and Notified Bodies (“Regulation”) was published in the Official Gazette dated May 27, 2021, … Read more

The European Union Medical Devices Regulation 2017/745 (“MDR”) came into effect in all member states as of May 26, 2021, … Read more

Turkish Medicines and Medical Devices Agency (“TITCK”) has published an updated Guideline on Distribution of Free Promotional Samples and Press … Read more