India’s health ministry, the Central Drugs Standard Control Organization (CDSCO), has amended its Medical Devices Rules 2017 to simplify the approval process for in-vitro diagnostic (IVD) devices. All NABL-accredited labs will have the power to carry out performance evaluation reports (PER), which are required for product approval, on IVD devices.
The amendment is predicted to have a significant impact on the registration process for IVDs. The Assistant Drug Controller of the CDSCO, Dr. Ravi Kanth, stated that the policy change “will facilitate ease of doing business as a manufacturer can now obtain the PER from any accredited laboratory in the country.”
Before, only one organization, the National Institute of Biologicals (NIB), was authorized by the CDSCO to test IVD devices, specifically those for HIV, Hepatitis B, Hepatitis C, blood grouping sera, glucose test strips, and analyzer-based glucose reagents. No laboratory had been designated for IVDs for malaria, dengue, syphilis, typhoid, tuberculosis, and cancer markers.
Now, a device manufacturer can obtain a PER from any NABL-accredited lab or facility approved bythe National Accreditation Board for Hospitals and Healthcare Providers. This means manufacturers can get their products tested near their own facilities, which should shorten the time it takes for device makers to secure manufacturing licenses.
The CDSCO plans to continue its efforts to streamline the registration processes for medical devices. Soon, the health authority may eliminate the clinical trial requirement for IVDs that have been marketed for at least two years in the UK, the US, and/or Canada to increase patient access to these diagnostics.