Indian Medical Device Registration and Approval

1 Hour Video | Namrata Nadkarni, Alcon Laboratories India Pvt. Limited

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.

 

Participants that will find this webinar most beneficial will be those involved in medical device companies.  Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Regulatory Submissions

NADKARNI
Namrata Nadkarni
Regulatory Affairs Manager
Alcon Laboratories India Pvt. Limited

Currently working as Regulatory Affairs Manager for Alcon Laboratories (India) Pvt. Limited. Ensuring the regulatory approvals, Pharmacovigilance and quality functions. In the 15 Years career working with US, European, ASEAN and Indian regulations, gained rich experience in Regulatory Affairs, Quality Assurance and Quality Control for Pharmaceutical products, Medical Devices and Food/consumer products.


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