India-UK Trade Deal Eases Medical Device Regulations, Sparks Industry Debate
The India-UK trade pact eases regulatory barriers for medical devices but raises rerouting concerns.
The recently enacted India-UK Comprehensive Economic and Trade Agreement (CETA) has initiated a significant move towards mutual recognition of medical device regulations between the two nations. Enforced from July 15, the agreement encourages both countries to acknowledge each other's regulatory standards, provided these meet their respective regulatory objectives. This development is expected to simplify market access and bolster trade in the medical devices sector.
Mutual Recognition and Industry Optimism
Pavan Choudary, Chairman of the Medical Technology Association of India (MTaI), views this regulatory harmonization as a crucial step towards India’s ambition to become a top-five global MedTech manufacturing hub by 2030. He also suggests that this agreement could serve as a model for future trade negotiations with the European Union, potentially reducing compliance costs for Indian companies aiming to engage with the UK's National Health Service (NHS).
The NHS's procurement system, which is government-funded, emphasizes pricing as a key factor for tender eligibility. The acceptance of Indian regulatory standards could thus facilitate reduced costs and enhance competitive participation in these tenders.
Concerns Over Third-Country Rerouting
Despite the optimism, domestic manufacturers express concerns about potential trade diversion through third countries. Rajiv Nath, Forum Coordinator for the Association of Indian Medical Device Industry (AIMED), warns against the exploitation of reduced duty access by producers from other countries via the UK. He calls for stringent rules of origin and customs safeguards to protect India’s nascent and import-dependent medical device industry.
Nath highlights that the issue extends beyond Chinese goods to include EU products that could take advantage of lower duties. This rerouting concern is not new for India, which has seen similar patterns with imports from Singapore and the Netherlands, leveraging efficient ports and favorable tax regimes.
Current Trade Dynamics and Industry Recommendations
India's reliance on imports to meet its medical device demands is evident in its trade dynamics with the UK. In 2025, India's exports to the UK amounted to approximately Rs 1,190 crore, whereas imports were more than double at Rs 2,200 crore. Key exports include spectacle lenses and single-use plastic disposables, while imports feature high-end devices such as ventilators and X-ray machines.
Industry representatives involved in the CETA negotiations emphasize the need for comprehensive disclosure of both legal and actual manufacturers in all FTAs. This measure, aligned with the Central Drugs Standard Control Organization (CDSCO) guidelines, aims to prevent trans-shipment from undisclosed locations and ensure transparency in trade practices.