CDSCO mandates online safety reporting for Medical Devices

Following pharmaceuticals, the Central Drugs Standard Control Organisation (CDSCO) has mandated that manufacturers of medical devices and in-vitro devices submit their safety reports online.

The Drugs Controller General of India, has issued the directive on 19th March 2024 for online submission of Period Safety Update Reports for Medical Devices and in-vitro devices, aimed at improving post-market surveillance data evaluation

Effective 1 April 2024, the option to submit applications offline in hard copy or any other method will no longer be available

A PSUR is a vital pharmacovigilance document that assesses the risk-benefit balance of a drug product after its authorization, providing a comprehensive analysis based on all available information, including new data.
This report determines whether additional studies are necessary or if modifications are needed

This is part of efforts to overhaul India’s drug regulation framework and enhance safety transparency.

Source: https://cdsco.gov.in/opencms/opencms/en/Latest-Circulars/
https://www.livemint.com/