Summary
“MedTech in India is poised to generate $50 billion in revenues by 2030.”
In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Sanjay Arudi, VP of Regulatory and Quality at GE Healthcare in India, to discuss the rapidly evolving MedTech environment in India. They explore the current state of the MedTech industry, government initiatives supporting healthcare, the regulatory landscape, and the importance of post-market surveillance. Sanjay shares insights on the challenges faced in regulatory compliance and offers career advice based on his extensive experience in the field. The conversation highlights India's potential to become a significant player in the global MedTech market by 2030.
Listen to the full 30-minute podcast or jump to a section of interest listed below.
Chapters
00:20 Introducing Sanjay Arudi
01:25 Current State of MedTech in India
03:24 Government Initiatives and Domestic Manufacturing
07:44 How Tariffs Might Impact MedTech Companies
09:12 Regulatory Environment for Medical Devices
14:06 Post-Market Surveillance and Reporting Requirements
19:50 Regulatory Compliance Challenges in India
22:33 Career Insights and Advice from Sanjay
25:31 Announcements, Key Takeaways and Future Outlook
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Suggested links:
LTR: An exciting growth opportunity for MedTech in India.
LTR: Navigating the regulatory landscape for SaMD in India.
ACHIEVE: FMEA Workshop.
Key Takeaways
India's MedTech industry is projected to generate 50 billion by 2030.
Government initiatives are crucial for expanding healthcare access.
80% of medical devices in India are currently imported.
The CDSCO license facilitates entry into multiple markets.
Post-market surveillance is becoming increasingly important.
Regulatory compliance requires collaboration with regulators.
Transparency in reporting adverse events is essential for patient safety.
India's healthcare market is rapidly evolving post-COVID.
Investments in domestic manufacturing are on the rise.
Career success in regulatory roles requires active contribution and solution-oriented thinking.
Keywords
MedTech, India, healthcare, regulatory environment, government initiatives, post-market surveillance, medical devices, industry growth, career advice, healthcare innovation
About Sanjay Arudi
Sanjay Arudi is the Vice President of Regulatory and Quality at GE Healthcare. He has over 30 years of professional experience in engineering, management and senior leadership roles. His expertise includes product transfers, program management, implementation of Quality & Regulatory requirements across Design, Sourcing, Manufacturing, Install Base & Commercial activities. He has many years of experience in working with global regulators in creating a compliant & friendly manufacturing environment. He holds a Bachelor’s degree in Polymer Science & Technology.
Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.
Disclaimer
Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.
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