CDSCO Approves 9 More Medical Device Testing Laboratories Across India

As per CDSCO, these laboratories conduct assessments and testing of medical devices on behalf of manufacturers, adhering to the guidelines specified in Form MD-40 under the MDR, 2017.

The Central Drugs Standard Control Organisation (CDSCO) has approved nine additional Medical Device Testing Laboratories (MDTL), including HLL Lifecare Ltd's laboratory and the Atal Incubation Centre (AIC), Medivalley, located at the Andhra Pradesh MedTech Zone (AMTZ).'¯

With these new additions, the total number of approved laboratories in the country for conducting tests under the provisions of the Medical Devices Rules (MDR), 2017, has increased from 30 to 39.

According to CDSCO, these laboratories are registered to perform tests or evaluations of medical devices on behalf of manufacturers, as outlined in Form MD-40 under the MDR, 2017.

HLL Lifecare's laboratory, situated at the company's headquarters in Thiruvananthapuram, has received approval to test 87 medical devices across Class A, B, and C categories.

The laboratory at AIC-AMTZ Medivalley Incubation Council, located in Visakhapatnam and funded by NITI Aayog under the Atal Innovation Mission, has been approved for three tests:

It's worth noting that AMTZ is one of the world's largest medical technology manufacturing clusters.

The other approved laboratories include Viridian Testing Laboratories in Tirupur (6 device tests), Bee Pharmo Labs Pvt Ltd in Mumbai (13 device tests), QVC Certification Services in Ambala, Haryana (30 device tests), Vardan Envirolab in Manesar, Gurugram (sterility and bacterial endotoxin testing for Class A, B, C, and D devices), Edward Food Research and Analysis Centre in Rajarhat, Kolkata (7 device tests), Maeon Lifescience Laboratories in Vanagaram, Tamil Nadu (33 device tests), and Trustin Analytical Solutions in Chennai (11 device tests).

The Ministry of Health and Family Welfare (MoHFW) has been actively working to increase the number of MDTLs, including involving state governments in establishing or designating existing laboratories as State MDTLs.'¯

This move aligns with the aim of supporting the expansion of testing laboratories for medical devices across India as the sector undergoes a significant regulatory shift, including introducing a licensing regime.

CDSCO had previously called upon laboratories with the capacity to test medical devices and adequate quality accreditation to submit applications, strengthening the MDTLs network in the country.

The medical device sector in India experienced a notable regulatory transformation in 2017 with the introduction of the Medical Device Rules, 2017, framed by the MoHFW. These rules aimed to comprehensively regulate medical devices, focusing on quality, safety, and efficacy under the Drugs and Cosmetics Act 1940.

Over the past decade, India's healthcare domain has experienced a remarkable expansion, positioning the country as a significant player in the worldwide medical device market.

Commending India's potential to take the forefront in the medical device industry, Union Health Minister Mansukh Mandaviya, while attending the inauguration of Medtech Expo 2023 in Gandhinagar, said that India's moment to lead the medical device market has arrived '“ and it's happening now. He highlighted India's well-established reputation as the "pharmacy of the world" and emphasised that it's time for the nation to produce cost-effective, cutting-edge, high-quality medical devices.