33 min
#27 Indian Medical Devices with Sundeep Agarwal, CDSCO, EU MDR, regulatory frameworks and future growth The MedTech Podcast
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- Life Sciences
Sundeep serves regulators and industry professionals alike, he frequently contributes to industry & government collaborated conferences as a speaker and panelist. A prominent guest lecturer in various MBA and Pharmacy educational institutions in India.
He is a lead auditor for medical devices and has expertise in ISO 13485, EU MDR, IVDR, CE Certification, CER, PMS, USFDA, 510(K), ISO 14971, MDSAP. He has delivered multiple global webinars for medical devices, diagnostics and life science companies. He is currently associated with Datt Mediproducts, India as a General Manager - Compliance & Regulatory Affairs, in addition to being an active member of a Technical Group (Software as Medical Device) at Global Harmonization Working Party.
On this episode he discusses how India is the fourth largest medical device market in Asia worth approx. $12 billion in 2022, its dominance in consumables and disposables, the process for exporting and importing medical devices from India, the regulatory frameworks of the region, the challenges of the EU MDR and IVDR in both the EU & UK, how to keep up to date with the everchanging regulatory environment, what makes the area of Bangalore a hotspot for MedTech and the similarities in regulation around the world.
Get in touch with Sundeep Agarwal https://www.linkedin.com/in/sundeep-agarwal-5680342a/
Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/
Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical
Subscribe to the Podcast
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Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support
Sundeep serves regulators and industry professionals alike, he frequently contributes to industry & government collaborated conferences as a speaker and panelist. A prominent guest lecturer in various MBA and Pharmacy educational institutions in India.
He is a lead auditor for medical devices and has expertise in ISO 13485, EU MDR, IVDR, CE Certification, CER, PMS, USFDA, 510(K), ISO 14971, MDSAP. He has delivered multiple global webinars for medical devices, diagnostics and life science companies. He is currently associated with Datt Mediproducts, India as a General Manager - Compliance & Regulatory Affairs, in addition to being an active member of a Technical Group (Software as Medical Device) at Global Harmonization Working Party.
On this episode he discusses how India is the fourth largest medical device market in Asia worth approx. $12 billion in 2022, its dominance in consumables and disposables, the process for exporting and importing medical devices from India, the regulatory frameworks of the region, the challenges of the EU MDR and IVDR in both the EU & UK, how to keep up to date with the everchanging regulatory environment, what makes the area of Bangalore a hotspot for MedTech and the similarities in regulation around the world.
Get in touch with Sundeep Agarwal https://www.linkedin.com/in/sundeep-agarwal-5680342a/
Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/
Follow Karandeep on YouTube - https://www.youtube.com/c/QRAMedical
Subscribe to the Podcast
---
Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support
33 min