The ongoing India-EU Free Trade Agreement (FTA) negotiations are crucial for India’s medical devices sector, as they hold significant implications for trade, tariffs, and regulatory barriers. India seeks reciprocal concessions to enhance its export potential while ensuring a level playing field.

Key Data and Market Challenges

Aspect	Details
Tariffs on Medical Devices	India imposes tariffs ranging from 0% to 10%.
EU’s Position	Seeks zero tariffs but maintains strict regulations.
Certification Costs	€60,000 to €300,000 annually for EU approval.
Approval Timelines	Increased from 4-8 months to 2-3 years.
India’s Exports (2024)	USD 2.3 billion (medical devices globally).
India’s Imports (2024)	USD 4.7 billion (medical devices globally).
Trade with EU	Exports: USD 580 million; Imports: USD 1.15 billion.
Regulatory Challenges	High certification costs, complex entry barriers.
MDSAP Status	India is excluded, limiting acceptance in global markets.

Key Challenges & Strategic Considerations

• Regulatory Barriers: The EU’s strict medical device regulations create high entry costs for Indian exporters.
• Trade Balance Concerns: A one-sided tariff reduction could lead to a surge in EU imports while limiting India’s exports.
• Market Access Issues: Without mutual recognition agreements (MRAs), Indian devices face difficulties in global acceptance.
• Withdrawal from EU Market: Many Indian exporters are exiting due to increased costs and extended approval timelines.

Need for Reforms and Negotiation Strategy

To strengthen its position in the FTA, India should:

• Push for harmonized ISO standards with the EU.
• Secure mutual recognition agreements (MRAs) to ease market entry.
• Ensure tariff reciprocity to protect domestic manufacturers.
• Advocate for India’s inclusion in MDSAP to enhance global acceptance.

Conclusion

The India-EU FTA presents both opportunities and challenges. Balanced negotiations are essential to ensure India’s medical devices sector remains competitive while expanding its global footprint. Addressing regulatory and tariff barriers will be key to maximizing India’s export potential in this critical sector.