TDR

Empowering global MedTech innovators with clarity, compliance, and confidence in India.

Frequently asked questions

Common questions about entering the Indian MedTech market

FAQ's

What are the key regulatory requirements for medical devices in India?

Medical devices in India are regulated under the Medical Device Rules (MDR) 2017. Key requirements include device registration, quality management system certification, import licensing, and compliance with Indian standards. The regulatory pathway varies based on device classification (Class A, B, C, or D).

How long does it typically take to enter the Indian market?

Market entry timelines vary based on device complexity and regulatory requirements. Typically, it takes 6-18 months for regulatory approvals, plus additional time for market setup, partner identification, and commercial launch. Our structured approach helps accelerate this process.

What are the main challenges foreign companies face in India?

Common challenges include navigating complex regulations, understanding local market dynamics, identifying reliable partners, managing price sensitivity, and establishing sustainable distribution networks. Cultural adaptation and local expertise are crucial for success.

What investment is typically required for India market entry?

Investment requirements vary significantly based on market approach, product portfolio, and business model. Factors include regulatory costs, local setup expenses, inventory requirements, marketing investments, and working capital. We help optimize investment strategies for maximum ROI.

Get in touch with us to discuss your MedTech opportunities in India

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Tower 3, Unit 1601, Harmony Towers, Sector 50 Gurugram – 122018, Haryana, India

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