A Periodic Safety Update Report (PSUR) is a document aimed at providing an update on the safety experience of a medicinal product worldwide to regulatory authorities at specific time points after its authorization. The purpose of PSURs is to evaluate the balance of risks and benefits of medicines after their authorization, taking into account the latest safety information and cumulative data on risks and benefits. These reports are crucial for monitoring and ensuring the safety of medical products.

Content of PSUR

(a) Title Page:

The title page of PSUR shall capture the name of the Medical device; reporting interval; approved

indication of Medical devices; date of approval of the medical device; date of marketing of medical device; licence name and address.

(b) Introduction:

This section of PSUR shall capture the reporting interval; medical device’s intended use, mode of action or principle of operation, risk class and a brief description of the approved indication and population.