A parliamentary committee has raised serious concerns over the country’s capacity to test and regulate radiation-emitting medical devices, such as X-ray machines and MRI scanners. In its fifth report submitted to Parliament, the Standing Committee on Consumer Affairs, Food, and Public Distribution emphasized the urgent need for reforms in national testing infrastructure.
The report highlights significant shortcomings in the capabilities of the National Testing House (NTH), which currently lacks the expertise and infrastructure to comprehensively test and certify these critical medical devices. While regulatory oversight is provided by the Atomic Energy Regulatory Board (AERB) and the Central Drugs Standard Control Organization (CDSCO), coordination gaps and resource constraints hinder effective regulation.
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Key Recommendations
The committee has proposed a range of reforms to address these challenges, including:
- Enhancing the specialized testing capabilities of NTH.
- Investing in advanced testing infrastructure and technology.
- Implementing staff training programs for upskilling.
- Establishing collaborations with leading research institutions.
Additionally, the report pointed out the limited geographical coverage of NTH testing centers, which are currently concentrated in six cities: Ghaziabad, Kolkata, Bengaluru, Jaipur, Guwahati, and Mumbai. The committee urged the establishment of at least one testing center in every state and called for increased funding to expand and strengthen testing facilities nationwide.
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How Operon Strategist Can Guide:
In response to these regulatory challenges, Operon Strategist is leading the way in providing comprehensive solutions for medical device manufacturers. Operon Strategist offers end-to-end consultancy services tailored to meet the highest standards of quality and compliance, including:
- Medical Device Testing Support: Guidance in ensuring devices meet global and local regulatory requirements.
- Regulatory Compliance Assistance: Expertise in navigating certifications from CDSCO, US FDA 510(k), CE marking, UKCA, SFDA and other regulatory bodies.
- Turnkey Project Guidance: Comprehensive support including plant facility layout design, Quality Management System (QMS) implementation, and achieving safety certifications like ISO 13485 and MDSAP.
- Infrastructure Development: Assistance in setting up state-of-the-art testing facilities and laboratories equipped with advanced technologies
- Training and Capacity Building: Customized training programs for healthcare professionals and technical staff.
If you’re a medical device manufacturer looking to ensure compliance with evolving regulations or need support in quality assurance, partner with Operon Strategist today. With our expertise, you can enhance your products’ reliability, meet global standards, and stay ahead in a competitive healthcare market.
