New Delhi/ Mumbai: The India India-UK Comprehensive Economic and Trade Agreement (CETA), has laid the groundwork for mutual recognition of regulatory clearances of medical devices between the two countries.
The agreement which came into force starting July 15, states that India and the UK will give positive consideration to accepting the other country’s technical regulations as equivalent, provided the importing country is satisfied that the other’s regulations adequately fulfill its own regulatory objectives.
It also states that if a party refuses to accept a regulation as equivalent, it must provide the requesting Party with the reasons for that decision within a reasonable timeframe. A similar principle applies to product testing and regulators are encouraged to accept results from the other territory.
Pavan Choudary, Chairman, Medical Technology Association of India (MTaI) called this a consequential provision which could be the key to India’s ambition of becoming a top-five global MedTech manufacturing hub by 2030.
“This is also a proof-of-concept India can replicate with the EU and could act as a template for India in future trade agreement, he added.
Notably, the UK operates a government-funded procurement system through the National Health Service (NHS), where pricing plays a key role in eligibility for tenders. Greater acceptance of Indian regulatory standards could help reduce incremental compliance costs for companies seeking to participate in these procurement opportunities.
Speaking for domestic manufacturers, Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AIMED) said, “While the agreement opens doors for export growth and fair competition with British manufacturers, we caution against the risk of third‑country producers exploiting reduced duty access via the UK and strict rules of Origin Customs Safeguards are essential to protect India’s nascent, import‑dependent industry.”
According to Nath, the industry’s concern is not limited to Chinese origin goods but extends to EU products that may exploit lower duty access.
India has already experienced this with Singapore and Netherlands which rank among the top five suppliers of medical devices to India, driven by their efficient ports and tax regime despite limited domestic manufacturing, in contrast to stronger production economies like Japan, Korea, Taiwan in Asia and France, Italy, and Spain in EU, he said
Currently, India remains heavily reliant on imports to meet its medical device needs, a pattern that is also evident in the current trade dynamics between the two countries.
In 2025, India’s medical device exports to the UK stood at around Rs 1,190 crore, while imports were more than double, reaching Rs 2,200 crore, according to industry estimates.
Top exports to the UK include spectacle lenses, single use plastic disposables and implants, whereas imports feature high-end devices such as ventilators, X-ray machines, and IVD analysis instruments.
Industry representatives involved in the negotiations stressed that every FTA, including this one, must require disclosure of both legal and actual manufacturers, in line with CDSCO guidelines, to prevent trans-shipment from undisclosed locations.
