Streamlining Medical Device Safety: CDSCO’s New Online PSUR Guidelines in India

Introduction: CDSCO has revolutionized safety reporting for medical devices and in-vitro diagnostic devices in India. As of March 19, 2024, all manufacturers must submit safety reports online through the Sugam portal. This blog explores the significance of these reports, their components, and the streamlined submission process.

What is Periodic Safety Update Reports (PSURs)?

Periodic Safety Update Reports (PSURs) are vital for investigational medical devices, demonstrating post-sale performance. Integral to Post-Market Surveillance (PMS), these reports monitor device safety and efficacy.

Key Components of PSURs:

PSURs comprise crucial sections, including device introduction, global authorization status, safety actions, reference updates, patient exposure estimates, individual case histories, study summaries, and risk management plans.

PSUR Submission Requirements:

Manufacturers and importers of investigational medical devices are responsible for timely and accurate PSUR submissions. Reports are due biannually for the first two years, annually thereafter, or as needed based on health requirements. All submissions must now be made through the Sugam portal.

Conclusion:

PSURs are more than paperwork; they are essential for post-sale medical device safety. By meticulously analyzing safety data, companies and regulators ensure devices meet safety standards and perform effectively. This continuous monitoring fosters trust in medical technology.

Regulatory Solutions India (RSI): RSI specializes in regulatory consultancy for medical devices. Contact us for assistance in navigating PSUR submissions and ensuring compliance with evolving regulations.

1. What is a PSUR, and why is it important for medical device manufacturers?

A PSUR is a critical report demonstrating the post-sale performance of investigational medical devices. It ensures devices remain safe and effective for patient use.

2. What information should be included in a PSUR?

PSURs should detail device intended use, global authorization status, safety actions, updates, usage estimates, research findings, and overall safety reviews.

3. Who is responsible for submitting PSURs, and when should they be submitted?

Manufacturers and importers must submit PSURs. Reports are due biannually for the first two years, annually thereafter, or as needed based on health requirements.

4. How has the submission process for PSURs changed in India?

As of March 19, 2024, CDSCO mandates online PSUR submissions through the Sugam portal, streamlining the process and ensuring greater organization.

5. Why are PSURs considered crucial for maintaining trust in medical technology?

PSURs play a critical role in ensuring investigational medical devices remain safe post-sale. By monitoring safety data, companies uphold patient and healthcare professional trust in medical technology.