A significant partnership has emerged between the Central government and 50 private laboratories to conduct quality, safety, and efficacy tests on medical devices.
Currently, only six government labs have the capacity to test specific devices, but they struggle to meet the escalating demand.
India’s medical devices sector, valued at $11 billion in 2020, represents 1.5% of the global market. An unnamed official explained the challenges, stating that establishing new labs requires substantial time and manpower. Unlike drugs, medical devices need diverse tests covering physical, medical, microbiological, chemical, and electrical aspects.
The official also highlighted the need for more private testing labs under the Medical Devices Rules, 2017. Hence, 50 private labs have been registered to assess device quality, enabling manufacturers to verify adherence to standards.
As reported by Livemint, efforts are underway to enhance private labs to government lab standards, expanding their testing capabilities. These labs cover various medical devices, including electronic equipment, implants, consumables, surgical instruments, and diagnostic reagents.
While testing at government labs is free, private labs will charge for their services. Additionally, state labs are being urged to contribute to medical device testing, aligning with the government’s strategy to reduce India’s reliance on imported devices through initiatives like medical device parks and clusters.