Introduction to Central Drugs Standard Control Organisation (CDSCO) approves nine more MDTLs, taking the total labs to test the medical device industry?
The Central Drugs Standard Control Organisation (CDSCO) has recently approved nine additional Medical Device Testing Laboratories (MDTLs), increasing the total number of such facilities in India to 39. This expansion aims to enhance the testing and evaluation infrastructure for medical devices, ensuring their quality, safety, and efficacy.
Key Highlights:
- Notable Approvals: Among the newly approved laboratories are HLL Lifecare Ltd.’s facility in Thiruvananthapuram, authorized to test 87 devices across Class A, B, and C categories, and the Atal Incubation Centre (AIC) at Medivalley in the Andhra Pradesh MedTech Zone (AMTZ), approved for specialized tests on electro-medical devices.
- Geographical Distribution: The approvals cover laboratories across various regions, including Viridian Testing Laboratories in Tirupur, Bee Pharmo Labs Pvt Ltd in Mumbai, QVC Certification Services in Ambala, Haryana, Vardan Envirolab in Manesar, Gurugram, Edward Food Research and Analysis Centre in Kolkata, Mason Life Science Laboratories in Vanagaram, Tamil Nadu, and Trustin Analytical Solutions Pvt Ltd in Chennai.
- Government Initiatives: The Ministry of Health and Family Welfare is collaborating with state governments to establish or designate existing laboratories as State MDTLs, aiming to further expand the testing infrastructure.
This strategic enhancement of testing capabilities is expected to support the growing medical device sector in India, facilitating compliance with regulatory standards and promoting public health.
