India Device Regulatory Update

Recently, Prime Minister Narendra Modi’s Ministry of Health published a 108 page notification on medical devices in India. Significant changes to medical device regulations include:

  1. Device licenses will no longer expire. The manufacturer will need to pay a renewal fee every 5 years to continue marketing the product.
  2. Device registration approval for imported devices will take an estimated maximum of 9 months. Registration will automatically imply import license and will eliminate the 3 month wait for an import license.
  3. If the Ministry of Health fails to complete a regulatory process in a pre-determined amount of time, then the license will be “deemed” to be approved.

The new regulations will come into effect January 2018.