Industry

Boost for Medical Device Testing: CDSCO approves Nine New Laboratories

Additionally, efforts are underway to implement enabling rules that facilitate the establishment of more medical device testing laboratories across the country.

The Health Master

September 21, 2023

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CDSCO Central Drug Standard Control Organisation — CDSCO

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Last Updated on December 31, 2023 by The Health Master

Medical Device Testing

The Central Drugs Standard Control Organization (CDSCO) has recently given the nod to nine additional Medical Device Testing Laboratories (MDTL) that submitted applications within this year.

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Noteworthy among them is the laboratory belonging to the public sector entity HLL Lifecare Ltd., as well as the Atal Incubation Centre (AIC) located at Medivalley, within the Andhra Pradesh MedTech Zone (AMTZ).

Download updated list of 39 Medical Device Testing Laboratories

Expansion of Testing Capabilities

This development marks a significant expansion in the capacity for testing medical devices.

The number of approved laboratories under the provisions of the Medical Devices Rules (MDR), 2017, has increased from the previous 30 to a current total of 39 nationwide.

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Empowering Manufacturers

These approved laboratories are now registered to conduct tests and evaluations of medical devices on behalf of manufacturers, operating under the guidelines set forth in Form MD-40, as outlined in the MDR, 2017, as detailed by the CDSCO.

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HLL Lifecare’s Impressive Portfolio

One of the noteworthy approvals goes to HLL Lifecare’s laboratory, situated at their headquarters in Thiruvananthapuram.

This laboratory is now equipped to test a total of 87 devices spanning across Class A, B, and C categories of medical devices.

AIC-AMTZ Medivalley Incubation Council’s Specializations

Another significant approval was granted to the laboratory operated by AIC-AMTZ Medivalley Incubation Council in Visakhapatnam.

This facility, funded by NITI Aayog under the Atal Innovation Mission, is located within AMTZ, recognized as one of the largest medical technology manufacturing clusters worldwide.

The laboratory is now authorized for three specialized tests:

Electro Medical Devices (EMC) Test for Radio Frequency Susceptibility
EMC Test for Electrical Fast Transient
EMC Test for Surge Immunity

Diverse Approvals Across India

A range of other Medical Device Testing Laboratories received approvals as well, each with unique capabilities:

Viridian Testing Laboratories, Tirupur (6 device tests)
Bee Pharmo Labs Pvt Ltd, Mumbai (13 device tests)
QVC Certification Services, Ambala, Haryana (30 device tests)
Vardan Envirolab, Manesar, Gurugram (Sterility and Bacterial Endotoxin for Class A, B, C, and D devices)
Edward Food Research and Analysis Centre, Rajarhat, Kolkata (7 device tests)
Maeon Lifescience Laboratories, Vanagaram, Tamil Nadu (33 device tests)
Trustin Analytical Solutions Pvt Ltd, Chennai (11 device tests)

Government Initiative for Sector Growth

The Ministry of Health and Family Welfare (MoHFW) has been proactively working towards increasing the number of MDTLs.

This includes collaboration with State governments to establish or designate existing laboratories as State MDTLs.

Additionally, efforts are underway to implement enabling rules that facilitate the establishment of more medical device testing laboratories across the country.

This shift is significant given the sector’s recent regulatory overhaul, including the introduction of the licensing regime.

Regulating the Medical Device Sector

The medical device sector operated largely unregulated until 2017. It was during this year that the Ministry of Health and Family Welfare (MoHFW) introduced the Medical Device Rules, 2017.

These rules were designed to comprehensively regulate medical devices in a phased manner, focusing particularly on aspects of quality, safety, and efficacy within the framework of the Drugs and Cosmetics Act, 1940 (D&C Act).

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.