The Central Drug Standard Control Organization (CDSCO) has recently made a change to how safety reports for medical devices and in-vitro diagnostic devices are submitted in India. Starting on March 19, 2024, all manufacturers have to submit these reports online through the Sugam portal. This new method is meant to make things easier and more organized. In this blog, we'll talk about why these reports are important, what they should include, and how to submit them.
Periodic Safety Update Reports (PSURs) are crucial reports, applicable to investigational medical devices, (i.e. devices without predicate) that manufacturers/importers of such medical devices need to submit to demonstrate how their products are performing after they have been sold. These reports are a key part of Post-Market Surveillance (PMS), a practice that monitors the safety and performance of investigational medical devices on the market.
A PSUR should have several parts that give a full picture of how a medical device is doing. Broadly, the MDR 2017 recommends that a PSUR to be structured as follows:
The companies that manufacture/import the investigational medical devices are the ones who need to prepare and send these reports. It’s important they do a good job of making sure the reports are accurate and sent on time.
Here’s when and how to send these reports:
Periodic Safety Update Reports are more than just paperwork—they’re crucial for keeping investigational medical devices safe after they are sold. By carefully looking at safety information, companies and regulators can make decisions that keep everyone safe and ensure devices work as they should. This ongoing monitoring is key to keeping trust in medical technology high.
At Regulatory Solutions India (RSI), we specialize in providing regulatory consultancy services for medical devices If you need help navigating the submission process or ensuring compliance with the latest regulations, contact us.
A Periodic Safety Update Report (PSUR) is a crucial report that investigational; medical device importers/manufacturers submit to demonstrate how their products are performing after they’ve been sold. It’s essential because it helps monitor the safety and performance of devices post-market, ensuring they remain safe and effective for patient use.
A PSUR should include details such as the device’s intended use, where it’s approved for sale, any safety actions taken, updates to safety information, estimates of device usage, research findings, and an overall safety review.
The responsibility for submitting PSURs lies with the companies that manufacture/import such investigational medical devices. PSURs should be submitted every six months for the first two years post-marketing, then annually for the next two years. Additional submissions may be required based on health needs.
As of March 19, 2024, the Central Drug Standard Control Organization (CDSCO) has mandated that all manufacturers/importers submit PSURs online through the Sugam portal. This change aims to streamline the submission process and ensure greater organization.
PSURs are more than just paperwork—they play a critical role in keeping investigational medical devices safe after they're sold. By carefully monitoring safety information and addressing any issues promptly, companies and regulators can uphold the trust of patients and healthcare professionals in medical technology.