Oct 23, 2019

India’s Central Drugs Standard Control Organization (CDSCO) has rolled out several changes to its regulatory process for medical devices and in-vitro diagnostic products.

  • First, CDSCO has added ultrasound equipment to its list of medical devices falling under regulatory requirements in India. The agency has set a compliance deadline of November 1, 2020 for ultrasound products to register for Indian market access.
  • Second, the regulator has identified several IVD products including tests for HIV, HBV, HCV and blood grouping reagents for which Performance Evaluation Reports (PER) will be required from external labs to be included in Import Permit Applications.
  • Third, CDSCO has issued a notification exempting all state and central government testing laboratories from National Accreditation Board for Testing and Calibration Laboratories (NABL) requirements for two years; these labs now face an October 2021 deadline for meeting NABL requirements.

Learn more about medical device and IVD regulatory issues in India: