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.

(c) Current worldwide marketing authorization status:

This section of PSUR shall capture the brief narrative overview including details of countries where the device is currently approved along with the date of first approval, date of marketing and if the product was withdrawn in any of the countries with reasons thereof.

(d) Actions taken in reporting interval for safety reasons:

This section of PSUR shall include a description of significant actions related to safety that have been taken during the reporting interval, related to either investigational uses or marketing experience by the licence holder, sponsor of a clinical investigation, regulatory authorities, data monitoring committee, or Ethics Committee.

(e) Changes to reference safety information:

This section of PSUR shall capture any significant changes to the reference safety information within the reporting interval. Such changes will include information relating to contraindications, warnings, precautions, adverse events, and important findings from ongoing and completed clinical investigations and significant non-clinical findings.

(f) Estimated patient exposure: