The medical device regulatory landscape in India is undergoing significant changes, presenting both challenges and opportunities for manufacturers. In our upcoming webinar, we aim to provide valuable insights and guidance for navigating this evolving regulatory environment. Join us as we explore the complexities of the current medical device regulatory scenario in India and equip you with the knowledge needed to thrive in this dynamic industry.
Understanding the Regulatory Framework:
Our webinar will kick off with an exploration of the regulatory framework for medical devices in India. Our presenters Sravan Manchikanti and Sushma Yedunuri will delve into the definition of medical devices, classification, and grouping, providing attendees with a comprehensive overview of the regulatory landscape.
Market Access Requirements:
Navigating the path to market access in India involves understanding various requirements for manufacturing and importing medical devices. We’ll discuss the types of applications required, clinical trial obligations, and the role of Indian Authorized Agents in facilitating market entry, ensuring attendees are well-prepared to navigate these complexities.
Post-Approval Obligations:
Given all the medical devices are regulated by CDSCO, understanding the Post-Approval implications is crucial. Our webinar will examine and delve into post-approval obligations, ensuring compliance throughout the product lifecycle and providing attendees with actionable insights for success.
Timelines and Regulatory Updates:
Attendees will gain insights into essential timelines for gaining market access and receive updates on recent regulatory developments, including the Drugs, Medical Devices, and Cosmetics Bill, 2022. Understanding these timelines and regulatory updates is crucial for strategic planning and compliance, and our webinar will ensure attendees are well-informed and prepared for the road ahead.
Case Study:
To provide practical insights, we’ll analyze a typical case study, highlighting the regulatory process and challenges faced by manufacturers. Through real-world examples, attendees will gain valuable perspectives on navigating regulatory complexities effectively, empowering them to overcome challenges and succeed in the Indian market.
Who Should Attend:
This webinar is tailored for managers and above from regulatory affairs, quality affairs, and medical/clinical affairs departments. Whether you’re a small startup or a large multinational corporation, understanding the current medical device regulatory scenario in India is essential for maintaining compliance and ensuring product success.
Join us for an engaging and informative webinar as we delve into the current medical device regulatory scenario in India. This webinar promises to provide invaluable insights, enabling you to navigate regulatory complexities with confidence. Don’t miss this opportunity to stay ahead in the ever-changing world of medical device regulations.
Register Now: https://events.teams.microsoft.com/event/fc2f76b8-e6d2-4049-a2d7-ba5c55ba2a72@a1244217-2c5c-4399-90f3-c581c4def0bc
Date: 29th May Time: 7.30 PM- 8.30 PM (IST)
Secure your spot today and take the first step towards mastering medical device regulatory compliance in India!
