Last Updated on October 10, 2024 by The Health Master
Medical Devices Testing Laboratories
In a major regulatory shift, the Ministry of Health and Family Welfare (MoHFW) plans to engage state governments in establishing or designating their existing laboratories as state medical devices testing laboratories (MDTLs).
A draft notification has been issued in this regard vide notification No. GSR 157(E) dated 01-03-2023.
This move aims to ensure the quality of medical devices by bringing in enabling rules to set up more MDTLs across India.
The MoHFW is amending the Medical Devices Rules, 2017, introducing sub-rules and changes to the existing ones relevant to create the desired regulatory framework.
Proposal for State Medical Devices Testing Laboratories
The MoHFW has notified a draft rule proposing the insertion of a new sub-rule to Rule 19.
The proposal suggests that the state government may establish state MDTls for testing and evaluating medical devices or carrying out other functions as specifically assigned to it.
The state government may also designate any laboratory with facilities for testing and evaluating medical devices as state medical devices testing laboratory, provided that the laboratory is accredited by the National Accreditation Body for Testing and Calibration Laboratories (NABL).
Central and State Governments Can Establish Laboratories
The amendment highlights that the laboratories could be established by either the Central or the state government.
A definition of the state MDTL has been added, stating that it means a laboratory established or designated by the state government under the newly proposed sub-rule of Rule 19(3).
The MoHFW aims to improve the quality and efficiency of testing medical devices through this regulatory shift.
Concerns Raised by Industry Experts
Industry experts have raised concerns about the availability of proper MDTL for faster testing operations.
The licensing regime for most medical devices is expected to be in place soon.
The Central Drugs Standard Control Organisation (CDSCO) has been requesting laboratories with adequate quality accreditation to submit applications to strengthen the MDTLs network in the country.
Remained unregulated Sector
The medical device sector remained largely unregulated until the MoHFW framed the Medical Device Rules, 2017, for comprehensive regulation of medical devices.
The rules focused on quality, safety, and efficacy aspects under the Drugs and Cosmetic Act, 1940. The sector is expected to grow from its current USD 11 billion to USD 50 billion by 2025.
Draft National Medical Devices Policy, 2022
The Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilizers, has released an approach paper on the Draft National Medical Devices Policy, 2022, which aims to address the core objectives of accessibility, affordability, safety, and quality.
The policy focuses on self-sustainability, innovation, and growth in the medical devices sector.
The policy envisions that by 2047, India will have National Institutes of Medical Devices Education and Research (NIMERs) similar to NIPERs.
India will be the originator of 25 high-end futuristic technologies in MedTech and will have a MedTech Industry worth USD 100-300 billion with 10-12% of the global market share.
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