In a significant breakthrough for the Indian medical device sector, the India-United Kingdom Free Trade Agreement (FTA) has introduced a Mutual Recognition Agreement (MRA) provision that aims to streamline the export of Indian medical devices to the UK market.

As of July 30, 2025, Indian medical devices certified by key Indian regulators such as the Central Drugs Standard Control Organisation (CDSCO) or the Indian Certification of Medical Devices (ICMED) are now eligible for simplified market access in the United Kingdom. This development is part of a broader effort to reduce trade barriers and promote bilateral cooperation in the healthcare and medical technology space between the two countries.

Zero Tariffs for Indian Medical Devices in UK

One of the most impactful provisions of the new agreement is the elimination of import tariffs on Indian medical devices entering the UK. Previously, these devices were subject to import duties ranging from 2% to 6%, which added to the overall cost burden for importers and, by extension, for healthcare providers and patients in the UK.

With zero tariffs now applicable, Indian medical device manufacturers gain a clear cost advantage over competitors from non-FTA countries such as China, Brazil, and Vietnam, who will continue to pay the standard duties. This change is expected to boost India's share in the UK’s lucrative medical device market, which was valued at Rs. 2,78,272 crore (approximately US$ 32 billion) in 2024.

According to projections, the UK medical device market is poised to grow at a compound annual growth rate (CAGR) of 7.19%, reaching Rs. 6,00,024 crore (US$ 69 billion) by 2035. The India-UK FTA's provisions now position Indian exporters to tap into this growing demand with improved competitiveness and market access.

Mutual Recognition of Indian Certifications

The FTA marks a critical step in international regulatory cooperation by establishing a Mutual Recognition Agreement (MRA) that effectively acknowledges the validity of Indian medical device certifications in the UK. Specifically, certifications from:

• Central Drugs Standard Control Organisation (CDSCO)

• Indian Certification of Medical Devices (ICMED)

are now considered acceptable for exports to the UK, subject to compliance with local UK regulatory frameworks. This shift significantly reduces the regulatory burden for Indian exporters, who no longer need to undergo lengthy and costly dual certification processes to enter the British market.

This recognition is not only a technical formality but a signal of growing trust between Indian and UK regulatory authorities, laying the foundation for long-term collaboration and market integration in the medical technology space.

Future Regulatory Collaboration: CDSCO and MHRA

To further strengthen bilateral trust and operational alignment, the agreement proposes future collaboration between:

• India’s CDSCO (Central Drugs Standard Control Organisation)

• UK’s MHRA (Medicines and Healthcare products Regulatory Agency)

This cooperation is expected to take the form of:

• Joint regulatory inspections for cross-verification and trust-building

• Harmonisation of technical documentation to align standards and simplify compliance

• Data sharing agreements to promote transparency and regulatory accuracy

• Mutual training programmes to ensure standardisation of review protocols

Such initiatives will facilitate smoother trade flows, reduce non-tariff barriers, and ensure faster approvals for Indian products in the UK—benefits that will be especially valuable to small and medium-sized manufacturers operating in India’s robust medical device ecosystem.

Stringent Rules of Origin to Prevent Abuse

To ensure that the tariff benefits under the FTA are not misused by third-country entities routing products through India or the UK, strict Rules of Origin (RoO) have been embedded in the agreement. These rules mandate that:

• Only products genuinely manufactured or substantially transformed in India will be eligible for tariff exemptions

• A digital certificate of origin system will be employed to validate claims

• Enhanced customs monitoring mechanisms will be activated for compliance verification

This framework ensures that only Indian-manufactured or Indian-transformed products benefit from duty concessions, thereby safeguarding the integrity of the trade deal and protecting India’s manufacturing interests.

Competitive Edge for Indian Manufacturers

Thanks to the provisions of this agreement, Indian manufacturers now enjoy a strong competitive edge in the UK market for a wide range of medical devices and instruments including:

• Diagnostic imaging equipment

• Surgical tools

• Patient monitoring systems

• Disposable medical items

• Orthopedic and rehabilitation devices

These manufacturers can now offer cost-effective products that meet recognised safety and quality benchmarks, without the need for duplicative regulatory approvals or duties. This opens up significant market expansion opportunities for Indian SMEs and startups operating in the healthcare technology space.

Additionally, the ease of access to the UK market may encourage Indian companies to invest in product innovation, R&D, and global quality benchmarks, as their certification frameworks will now be accepted beyond India’s borders.

Aligning with India’s Global Trade Vision

This agreement also reflects India’s strategic intent to deepen global trade partnerships in sectors where it has competitive potential. The government’s Make in India and PLI (Production Linked Incentive) schemes have already spurred growth in the medical device sector, and now the India-UK FTA provides the necessary international channel to support and scale these efforts.

Moreover, the framework reinforces India’s growing stature as a reliable supplier of high-quality healthcare technologies and will encourage further FTAs with other developed economies seeking trustworthy medical device sourcing partners.

Conclusion

The India-UK Free Trade Agreement has created new momentum for Indian medical device exports, offering a clear route into the UK market through zero tariffs and mutual recognition of Indian certifications. With the medical technology sector in the UK poised for robust growth, Indian manufacturers—especially those certified by CDSCO or ICMED—now have a decisive advantage over global competitors.

By building regulatory cooperation, enforcing Rules of Origin, and promoting digital transparency, the agreement provides a secure and enabling environment for bilateral trade in healthcare technologies.

For India, this is not merely an export opportunity—it is a strategic milestone in becoming a global hub for medical technology manufacturing, aligning seamlessly with national goals of innovation-driven growth and global market integration.

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