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, 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.
What will you learn?
The session will help participants understand:
- The regulatory landscape for Medical Devices, IVDs, and SaMDs.
- Key regulatory requirements for entering the Indian market.
- The US FDA regulatory pathway for medical devices.
- The European Union Medical Device Regulation (EU MDR) framework.
- Important regulatory considerations during different stages of medical device development.
- How early regulatory planning can support a smoother journey from development to market commercialization.
Topics Covered
- India: CDSCO Regulatory Framework
- USA: US FDA Regulatory Pathway
- Europe: EU MDR Regulatory Framework
Who should attend?
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.
Regulatory Support
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.
About the Experts
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.
Session Details
Date: 25 September 2026
Mode: Virtual
Session: Awareness Talk followed by Q&A
One-to-One Mentoring & 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.
How to Register
Interested participants can register for the session through the registration form below.
Please Note:
- Prior registration is required to attend the session.
- The session will be conducted virtually.
- Registered participants will receive the session joining details separately.
- Participants can interact with the experts during the Q&A session.
Get a clearer understanding of the regulatory pathway before taking your medical device to the next market.
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.
For more details please contact:
Deepak Kumar | +91 88177 71418