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Medical Device Pathway in India

Speaker: Ms. Parul Chansoria

India is one of the largest medical device markets in Asia and it is growing significantly. Medical device market in India is pegged at $6.3 billion in 2013 and growing annually at 10-12 percent. Most of it is dominated by imported products. According to a recent report by The Boston Consulting Group (BCG), around 70 per cent of the medical devices used in India are imported.

As per the risk-based classification of medical devices, Low risk devices to be marketed with self-certification and High risk devices to be marketed after obtaining conformity assessment. Currently, manufacturers of medical devices which require registration in India should supply evidence of marketing authorization in the US, Canada, Europe, Australia or Japan, plus proof of approval in their country of origin. Full technical documentation must be submitted for CDSCO approval. Additionally, each manufacturing facility must be registered.

This Webinar will provide a better understanding of what are DCGI expectations for Medical Device entry, Pathway in India, Medical Device Design & Quality standards, Import License and requirements for medical device clinical trials, product registration and product life cycle management.

Key Topics:

  • Medical Device Market
  • Indian Regulation & Entry pathway
  • Medical device Classification in India
  • Product Registration & Import Requirements
  • Regulatory Timelines
  • Clinical Trial of Medical Devices in India
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