INDIAN MEDICAL DEVICE REGISTRATION AND APPROVAL

In 2005, Indian Drug regulators listed 10 Medical Devices under the regulated medical device category, thereby mandating a license to market the product. Importers are required to obtain valid registrations and licenses for the imported device before marketing the product. The government is in the process of developing a rigorous set of regulations specific to medical devices and in-vitro diagnostics, which will update the current system in which devices are more loosely regulated. These changes include creating a new regulatory body known as the National Medical Devices Authority (NMDA), which will be accountable for safeguarding the safety and effectiveness of devices marketed in region, as well as enforcing price caps on a variety of products. This webinar will provide an overview of the medical device regulatory scenario in India, as well as the processes for obtaining approvals and documentation requirements.

Speaker:
Namrata Nadkarni
Regulatory Affairs Manager
Alcon Laboratories India Pvt. Limited

Contact:

Brooke Akins | Manager, Market Intelligence | 312.224.1693 webinars@q1productions.com