CDSCO Mandates Online Safety Reporting for Medical Device Manufacturers
New Delhi, March 19, 2024: Following suit with pharmaceutical regulations, the Central Drugs Standard Control Organisation (CDSCO) has made it mandatory for manufacturers of medical devices and in-vitro devices to submit safety reports online. The directive, issued by the Drugs Controller General of India, Rajeev Raghuvanshi, aims at enhancing post-market surveillance data evaluation by requiring online submission of Period Safety Update Reports.
Transitioning to Online Submission
Starting April 1, 2024, the option for offline submission, including hard copies or any other method, will no longer be available for processing. This move is part of a broader effort to modernize India’s drug regulation framework and improve transparency in safety reporting within the medical device industry.
Looking for Medical Device Consultant?
Let’s have word about your project
Significance of Period Safety Update Reports (PSURs)
PSURs play a crucial role in pharmacovigilance, assessing the risk-benefit balance of a drug product post-authorization. They provide a comprehensive analysis based on all available information, guiding decisions on additional studies or necessary modifications.
Streamlining Processes with the National Single Window System (NSWS)
To facilitate operations for the medical device industry, CDSCO introduced the National Single Window System (NSWS) on January 1, 2024. This platform, aligned with the Medical Devices Rules of 2017, acts as a one-stop shop for investor permissions, streamlining business processes by encompassing all required permits and clearances.
Read More: Government Launches NSWS Portal to Simplify Medical Device Approvals
Looking Ahead
The mandate for online safety reporting marks a significant step towards improving regulatory compliance and enhancing safety measures within the Indian medical device market. With these initiatives in place, stakeholders anticipate smoother processes and increased transparency in post-market surveillance.
For Further Information on Compliance With CDSCO’s Online Safety Reporting Mandate
Operon Strategist: Your Regulatory Compliance Partner
As the deadline for transitioning to online safety reporting for medical devices approaches, ensure your compliance with ease by partnering with Operon Strategist. With our in-depth knowledge of CDSCO regulations and extensive experience in regulatory compliance, we stand ready to guide you through this pivotal change. Contact Operon Strategist to streamline your Period Safety Update Reports (PSURs) submission process, helping you navigate the evolving landscape of medical device regulations in India.
Don’t wait until it’s too late – reach out to us today and let us be your compliance partner in ensuring the safety and transparency of your products.
