For innovators, startups, researchers, and MedTech teams developing Medical Devices, In-Vitro Diagnostics (IVDs), or Software as a Medical Device (SaMD), navigating regulatory requirements across different markets can often be challenging.
To help innovators better understand these requirements, the Regulatory Information and Facilitation Center (RIFC), Venture Center, along with IC IIT Patna, is organizing an Awareness Talk on Regulatory Requirements for Medical Devices in India, US and European Markets.
The session will introduce participants to the key regulatory frameworks and pathways that medical device innovators need to understand while planning to enter the Indian, US, and European markets.
The session will help participants understand:
This awareness session will be useful for MedTech startups, entrepreneurs, researchers, innovators, students, founders, and product development teams working on Medical Devices, IVDs, SaMDs, or other healthcare technologies who want to understand regulatory requirements for India, USA, and European markets.
The Regulatory Information and Facilitation Center (RIFC) at Venture Center provides end-to-end regulatory support to innovators, starting from the idea and development stage through market commercialization.
The team supports innovators in understanding regulatory pathways, identifying applicable standards, and determining the mandatory certificates, licences, and regulatory requirements needed throughout the lifecycle of Medical Devices, IVDs, and SaMDs.
Ms. Chetna Dabi - Associate Manager, Regulatory Services, Venture Center
Chetna works with the Regulatory Information and Facilitation Center (RIFC) at Venture Center and supports medical device innovators in understanding regulatory pathways, applicable standards, quality management systems, and regulatory requirements.
Mr. Akash Dhade - Associate Manager, Regulatory Services, Venture Center
Akash works with the Regulatory Information and Facilitation Center (RIFC) at Venture Center and supports organizations in regulatory pathway planning, technical documentation, standards identification, and regulatory submissions for Indian and international markets.
Mr. Joseph Paul Arackal - General Manager, IC IIT Patna
Mr. Joseph Paul Arackal will join the session from IC IIT Patna and contribute to the discussion on supporting innovators and entrepreneurs as they navigate the medical device development and commercialization journey.
Date: 25 September 2026
Mode: Virtual
Session: Awareness Talk followed by Q&A
Participants will also have an opportunity to interact with the experts after the awareness session, ask regulatory questions, and seek guidance relevant to their medical device or healthcare innovation.
Interested participants can register for the session through the registration form below.
Whether you are at the idea stage, developing your product, or preparing for market entry, this session will help you understand the regulatory requirements you need to consider for India, USA, and Europe.
Deepak Kumar | +91 88177 71418
DESCRIPTION:Understanding regulatory requirements early can make the journey from medical device development to market much smoother. For innovators, startups, researchers, and MedTech teams developing Medical Devices, In-Vitro Diagnostics (IVDs), or Software as a Medical Device (SaMD), navigating regulatory requirements across different markets can often be challenging. To help innovators better understand these requirements, the Regulatory Information and Facilitation Center (RIFC), Venture Center, alon... LAST-MODIFIED:20260920T080026Z LOCATION:Online... SEQUENCE:0 STATUS:CONFIRMED SUMMARY:The Regulatory Information and Facilitation Center (RIFC), Venture Center, in collaboration with IC IIT Patna, is organizing an Awareness Talk on Regulatory Requirements for Medical Devices in India, US and European Markets on 25 September 2026 in virtual mode. The session will help MedTech startups, innovators, researchers, founders, and product teams understand key regulatory pathways, including the CDSCO framework for India, US FDA requirements, and the EU MDR framework. Participants will also get an opportunity to interact with regulatory experts, ask questions, and seek guidance relevant to their medical device, IVD, or SaMD journey. TRANSP:OPAQUE END:VEVENT END:VCALENDAR