• Regulated medical devices will have to bear additional information on label from January 1, 2018
  • Declaration of country of origin or manufacture or assembly made mandatory on label of imported medical devices (both regulated and unregulated) from January 1, 2018

On June 23 2017, the Government of India notified an amendment to a law that regulates contents of labels of all pre-packaged goods sold in India. The amendment takes effect from January 1, 2018. The most significant aspect of the amendment is that the application of this law has been extended to all regulated medical devices, which presently enjoy exemption. The label of all regulated medical devices sold in India will have to bear certain additional declarations and particulars, failing which, criminal prosecution may be initiated.

In this update, we have discussed the background and analysis of the amendment in the paragraphs below.

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