The Indian medical device market is worth about $4.3 billion dollars and is expected to grow to about $12 billion dollars by 2022. With a population of 1.2 billion and a growing middle class, strong growth is projected for India’s medical markets in the years to come. Nowadays, more and more Western device companies are registering their products in India.
This webcast will give an overview of India medical device regulations and recent regulatory updates, such as new labeling requirements for medical device manufacturers. Key topics that are covered include the process and documentation required for medical device registration in India, conducting clinical trials, product re-registration, and import registration. Challenges in India’s product approval process are also highlighted in this webcast. For instance, in regards to registration renewals, the DCGI is now requiring that renewal dossiers have 3 years of post-market data. If your Indian office or Indian distributor is not keeping good track of PMS, you may not be able to renew your device license.
View this webcast for expert insight into the regulatory pathway for India’s medical device market.
To view the webcast presentation slides in PDF format, please click on India Medical Device Regulatory Update 2014 Webcast Slides.
Presenter
Ames Gross, President and Founder of Pacific Bridge Medical.
Overview
- India’s healthcare system
- India’s medical device market
- Regulatory environment – Regulators of medical devices
- Medical devices which need to be registered now
- New India medical device regulations and proposed legislation
- New product registration requirements
- Registration process
- Labeling and packing
- New label requirements under Standard of Weights and Measures Act (SWM)
- New post market surveillance regulations
- New best strategies for device renewal
- New Price controls
- Case Studies