- Faq's
Frequently asked questions
Common questions about entering the Indian MedTech market
FAQ's
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).
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.
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.
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
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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