The India-United Kingdom (UK) Free Trade Agreement (FTA) has introduced a Mutual Recognition Agreement (MRA) framework aimed at easing the export of Indian medical devices to the UK. Under this provision, devices certified by Indian regulatory authorities, namely the Central Drugs Standard Control Organisation (CDSCO) or the Indian Certification of Medical Devices (ICMED), will now enjoy simplified access to the British market. Medical devices and instruments will also benefit from zero tariffs, a major shift from the current import duty range of 2–6%. This development is expected to give Indian manufacturers a competitive edge over non-FTA exporters such as China, Brazil, and Vietnam, who continue to face full duties. The MRA provision aligns with broader efforts to expand India’s footprint in the UK’s growing medical devices market, which stood at Rs. 2,78,272 crore (US$ 32 billion) in 2024 and is projected to reach Rs. 6,00,024 crore (US$ 69 billion) by 2035, growing at a CAGR of 7.19%.
The agreement also outlines future regulatory cooperation between India’s CDSCO and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This cooperation will likely take the form of joint inspections, harmonisation of technical documentation, data sharing, and mutual training initiatives, helping build trust between the two regulatory regimes and reinforcing the legitimacy of Indian certifications in the UK market. Additionally, strong Rules of Origin (RoO) have been embedded in the agreement to prevent misuse of tariff benefits by third-country products routed through the UK. A digital certificate of origin system and customs monitoring will ensure that only genuinely Indian-manufactured or substantially transformed products receive duty concessions. Overall, the framework reflects India’s commitment to facilitating global market access while safeguarding its domestic manufacturing interests.
Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.