Context

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

• In vitro diagnostic medical devices are tests used on biological samples to determine the status of a person’s health. 

DCGI Mandated Online Safety Reporting for Medical Devices

• Online Submission of PSUR: The directive, issued by the Drugs Controller General of India (DGCI), has directed the online submission of Period Safety Update Reports (PSUR), aimed at improving post-market surveillance data evaluation. 
• Overhauling Drug Regulation: This is part of efforts to overhaul India’s drug regulation framework and enhance safety transparency.
• Launch of NSWS: To simplify operations for the medical device industry, CDSCO had launched the National Single Window System (NSWS) on 1 January 2024.
  • This platform, aligned with the Medical Devices Rules 2017, was developed by the central government to create a one-stop shop for all investor permissions, facilitating business processes. 
  • The NSWS encompasses all required permits and clearances.
• Period Safety Update Reports (PSUR): 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.