CDSCO Mandates Online Safety Reporting for Medical Devices

21 Mar 2024

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. 

Central Drugs Standard Control Organisation (CDSCO)

  • Nodal Ministry: Ministry of Health & Family Welfare 
  • Mandate: It is responsible for ensuring quality drugs supply across the country. 
  • DGCI has authority to give approval to new drugs and to regulate clinical trials.

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.
Also Read: CDSCO’s Guidelines for Unapproved Drugs Meropenem & Disodium EDTA

 

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