Indian Device Licenses Approved During the Pandemic Could be at Risk

On May 18, the Ministry of Health and Family Welfare announced a new Rule 43A, which outlines the conditions in which an approved device license can be canceled or suspended. Per this new rule, if a device license does not comply with all the requirements of an import license, the central licensing authority can act. During the pandemic, device licenses were often granted with certain conditions. Many applicants’ documents that were not notarized/apostilled and needed authenticated documents post-lockdown are now in jeopardy. License holders may submit an appeal within 30 days to the Indian government if they receive such notification.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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