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Jeet B Bhayani (SEBI RA)

30th Jul 2025 · SEBI-Registered Analyst

India-UK trade agreement enhances Indian medical device access in the UK.

The Free Trade Agreement (FTA) between India and the United Kingdom (UK) has established a Mutual Recognition Agreement (MRA) framework to facilitate the export of Indian medical devices to the UK. According to this regulation, devices approved by Indian regulatory bodies, specifically the Central Drugs Standard Control Organisation (CDSCO) or the Indian Certification of Medical Devices (ICMED), will now have easier access to the British market. Medical instruments and devices will likewise gain from zero tariffs, marking a significant change from the existing import duty range of 2–6%. This advancement is anticipated to provide Indian producers a competitive advantage over non-FTA exporters like China, Brazil, and Vietnam, which still endure complete duties. The MRA clause corresponds with larger initiatives to enhance India’s presence in the UK’s expanding medical devices sector, which was valued at Rs. 2,78,272 crore (US$ 32 billion) in 2024, with projections indicating it will escalate to Rs. 6,00,024 crore (US$ 69 billion) by 2035, increasing at a CAGR of 7.19%. The accord additionally specifies upcoming regulatory collaboration between India’s CDSCO and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This collaboration will probably involve joint inspections, standardization of technical documents, data exchange, and reciprocal training programs, fostering trust between the two regulatory systems and strengthening the validity of Indian certifications in the UK market. Furthermore, robust Rules of Origin (RoO) have been incorporated into the agreement to avert the exploitation of tariff advantages by products from third countries passing through the UK. A system for digital certificates of origin and customs oversight will guarantee that only products genuinely made in India or significantly transformed qualify for duty benefits.

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