We are delighted to see your interest in Freyr Webinar Series (FWS). The webinar on Indian Medical Device Regulatory Landscape- A Deep Dive is scheduled on September 22, 2021, for AMR, EUA & ROW regions.

What Is It All About?

The Indian medical device industry is considered as one of the fastest growing markets. The Indian regulatory agency, the CDSCO, make a conscious effort to improve its regulatory regime and release safe and efficient medical devices into the market. The CDSCO under the MDR 2020 - the recent amendment of Medical Device Rules (MDR) 2017, now require all devices imported and placed in Indian market to be mandatorily listed by October 2021, followed by their registration in upcoming years. As a device manufacturer, do you understand India’s current Regulatory dynamics, applicable regulations, and different device registration pathways? To help you better understand the vast Regulatory landscape of the Indian medical device industry, we bring you an exclusive webinar on:

 

Indian Medical Device Regulatory Landscape - A Deep Dive

September 22, 2021

Duration – 45 Minutes

Join the Webinar at your Convenient Time

For AMR and EUA Regions

10.00 AM EDT | 4.00 PM CEST

For RoW Region

11.30 AM IST

Host

Kristen Laudicina

Vice President, Strategic Accounts - Medical Devices

Kristen Laudicina is the Vice President of Strategic Accounts for Freyr’s Medical Devices Center of Excellence (CoE). She currently oversees the North and South American regions and supports Freyr’s Medical Device CoE team. Kristen has 12+ years of experience within Life Sciences, from Preclinical through Commercial Manufacturing, and understands the client’s needs from both a sponsor and service provider perspective.

Presenter

Sushma Yedunuri

Head Centre of Excellence - Indian Device Registration

Sushma Yedunuri leads Indian Medical Device Projects at Freyr and has 10+ years of experience exclusively in Indian Regulatory affairs and is responsible for delivering all the Indian registrations of medical devices and IVDs. Sushma is the domain expert in the Indian medical device regulations and has supported 100+ device manufacturers register their devices with the CDSCO. Her core proficiency is framing Regulatory strategies during device development, submission strategies, and driving the Regulatory submissions till device approvals. Sushma holds a master’s degree in Clinical Research Management.

In this webinar, our in-house Regulatory expert, Sushma Yedunuri, Head - Indian medical device projects, will elaborate on:

  • Overview of the Indian medical device industry and its Regulatory landscape
  • Changes in the Indian device regulations and the transition timelines for compliance
  • What are Notified and newly regulated devices and how they are regulated?
  • Registration pathways for device registration in India
  • Everything a device manufacturer needs to know about registration listing
  • Role of Indian Authorized Agent in end-to-end device compliance

Given the keynotes and with due respect to your busy schedule, we look forward to seeing you in the webinar. Register now! Stay informed. Stay compliant.