Indian Medical Device Exports See Opportunities in High-Growth Markets
India has significant opportunities to expand its medical device exports as several international markets record strong growth in medical equipment imports. A recent study by India Exim Bank, a government-owned institution supporting India’s international trade, identified Mexico, Brazil, the UK, Poland and Canada among the high-growth markets for medical equipment.
The findings highlight an important opportunity for Indian medical device manufacturers: entering markets where demand is increasing but India’s current export presence remains relatively limited.
The study assessed overseas markets where medical device imports grew faster than the global average between 2022 and 2024, while also requiring those countries to account for at least 1% of global imports in the relevant product categories.
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High-Growth Markets for Medical Devices
The study identified the following markets:
- Medical equipment: Mexico, Brazil, UK, Poland and Canada
- Orthopaedic equipment: Mexico, Ireland, Poland, Russia and the US
- PPE: Hungary, Turkey, Vietnam, Hong Kong and Mexico
- Consumables and disposables: Australia, UK, Saudi Arabia, Italy and Singapore
The report highlighted the gap between increasing import demand in these markets and India’s relatively limited presence. It recommended regulatory alignment, country-specific compliance support and targeted trade promotion to help Indian manufacturers expand internationally.
Regulatory Compliance Key to Global Expansion
India’s medical device trade deficit reached USD 4.9 billion in 2024, while its global medical device export share was around 1%. The National Medical Devices Policy 2023 aims to increase India’s global market share to 10–12% by 2047.
The study also emphasized the need for greater R&D, advanced manufacturing capabilities, skilled professionals and stronger quality infrastructure.
For manufacturers targeting markets such as the EU, UK, US, UAE, Oman and other international destinations, understanding product registration and regulatory requirements is essential for successful market entry.
Role of Operon Strategist
Operon Strategist can support Indian medical device manufacturers with:
- Global regulatory strategy for new export markets.
- Country-specific medical device registration and compliance.
- CE Marking, EU MDR/IVDR and UK regulatory support.
- US FDA regulatory pathways and documentation.
- ISO 13485 and quality management system support.
- Technical documentation and risk management.
- Regulatory planning for global market expansion and market access.
For Indian manufacturers, growing international demand presents an opportunity to diversify exports. Regulatory readiness can help convert these market opportunities into sustainable global market access.
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