Central Drugs Standard Control Organization (CDSCO), India has rolled out several changes to its regulatory process for medical devices and in-vitro diagnostic medical devices.
List of regulated medical devices- CDSCO has added ultrasound equipment to its list of medical devices falling under regulatory requirements in India. Compliance deadline of November 1, 2020 has been set for registration of ultrasound products to market in Indian.
Devices requiring Performance Evaluation Reports: CDSCO 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.
Exemption for state and central government testing laboratories: 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.