India Releases Final Audit Fees for Notified Bodies

India’s Drugs Controller General released its final audit fees for notified bodies under its new medical device regulations.

Annual surveillance assessments are expected to take one to three days, and organizations that are already certified to ISO 13485 from a notified body or CE mark for the same product will have a reduced fee schedule and audit.

The calculation of fees will be based on various factors including the risk class and number of employees.