About MTaI

• Educating policymakers and the public about the role of MedTech in disease prevention, early detection, and minimally invasive care
• Driving cross-sector dialogue to build trust and understanding in medical innovation
• Busting myths & misinformation MTaI seeks to find a space for MedTech commensurate to their contribution to healthcare

Our key focus areas include:

• Promoting balanced and rational pricing frameworks that support both accessibility and industry sustainability
• Advocating for technology-agnostic procurement models to ensure fair, outcome-based decision-making
• Addressing tariff and trade barriers that hinder affordability and timely availability of medical devices
• Aligning access strategies with national priorities such as Make in India, attracting Foreign Direct Investment (FDI), and leveraging Health Technology Assessment (HTA) principles

Current Regulatory Landscape:

• Medical devices are regulated by CDSCO under the Ministry of Health & Family Welfare.
• The Medical Devices Rules, 2017 introduced risk-based classification (Class A to D).
• Focus has increased on registration, import licensing, quality standards, and vigilance.
• The National Single Window Clearance System (NSWS) aims to streamline approvals across departments.

MTaI’s Role:

• Industry Representation: Active participation in stakeholder consultations and policy dialogues.
• Technical Contributions: Providing expert inputs on regulatory matters like product classification, licensing, labeling, and clinical evaluations.
• Regulatory Advocacy: Promoting transparent, predictable, and science-based regulations for quality assurance and market access.

Focus Areas:

• Advocacy for convergence with IMDRF, ISO, and WHO guidelines.
• Promotion of international benchmarking for product approvals, technical documentation, and compliance protocols.
• Supporting government efforts to position India as a global hub for MedTech innovation and manufacturing.

• Providing industry insights to support the development of training content aligned with the latest MedTech innovations.
• Collaborating with government stakeholders and skill development councils to shape skilling initiatives that address real-world gaps.
• Advocating for structured training and certification programs to enhance competencies in handling medical devices, especially in emerging and high-risk technologies.
• Supporting ecosystem-wide efforts to upskill frontline healthcare workers, biomedical engineers, and technicians for improved patient outcomes.