IIT Delhi Launches First BIRAC–RAPA National Regulatory Workshop; Upcoming Sessions Scheduled at AIIMS, RCB and GIMS Greater Noida

GREATER NOIDA News (19 November 2025): IIT Delhi today hosted the inaugural workshop of the BIRAC–RAPA (Regulatory Affairs & Pathways Advancement) national series, bringing together leading academic and clinical institutions to strengthen India’s MedTech regulatory landscape. The event marked the beginning of a multi-campus initiative designed to equip innovators with the skills required to navigate India’s evolving regulatory framework for medical devices.

Organized in collaboration with IIT Delhi, the Regional Centre for Biotechnology (RCB) Faridabad, AIIMS New Delhi, and the Government Institute of Medical Sciences (GIMS) Greater Noida, the workshop aims to build regulatory capacity among MedTech startups, researchers, and clinicians by offering hands-on exposure to compliance processes, documentation, and clinical approval pathways.

Key Highlights of the Inaugural Session

The first session at IIT Delhi focused on the most essential regulatory checkpoints that MedTech innovators must address prior to clinical deployment. Expert speakers shed light on:

1. Preparing critical documentation required for clinical trials

2. Selecting and defining the responsibilities of Principal Investigators (PIs)

3. Formulating robust study protocols

4. Effective presentation strategies for Institutional Ethics Committees (IEC/RC)

5. Mandatory requirements for CTRI registration

6. Navigating regulatory hurdles within clinical and hospital-based environments

Panelists reiterated that stronger collaboration between engineers, clinicians, and startups is vital for speeding up safe, compliant, and impactful MedTech development in India.

Workshops to Continue Across Partner Institutions

The national regulatory series will expand in the coming weeks to the other collaborating institutes. After the IIT Delhi session, workshops will next be hosted at: RCB, Faridabad ; AIIMS, New Delhi ; GIMS, Greater Noida. The concluding session at GIMS Greater Noida will place special emphasis on real-world clinical validation, OPD-based regulatory interactions, and preparing emerging MedTech companies for structured trial readiness within a government medical college environment.

Leadership Perspective from GIMS

Speaking on the significance of the initiative, the Director of GIMS Greater Noida stated: This national effort, jointly led by BIRAC and India’s top institutions, will enhance transparency and clarity in the MedTech regulatory pathway. GIMS is committed to supporting innovators with clinical access, documentation expertise, and thorough regulatory preparedness.

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