India and the United Kingdom have signed a groundbreaking Free Trade Agreement (FTA) that promises a significant boost to India’s medical device exports. One of the standout provisions is a Mutual Recognition Agreement (MRA), allowing the UK to accept certifications from India’s Central Drugs Standard Control Organisation (CDSCO) and the Indian Certification of Medical Devices (ICMED). This means that Indian medical products will now be able to enter the British market more easily, without needing duplicate approvals.
Adding to this momentum, Indian medical instruments will enjoy zero tariffs when entering the UK. This marks a big shift from the earlier import duty range of 2% to 6%, giving Indian exporters a distinct cost advantage over competitors from countries like China, Brazil, and Vietnam, who still face full tariffs. As a result, Indian manufacturers are better positioned to penetrate the UK’s growing healthcare market, which was valued at $32 billion in 2024 and is forecasted to touch $69 billion by 2035, reflecting an annual growth rate of 7.19%.
Beyond market access, the FTA also encourages long-term collaboration between India’s CDSCO and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This includes shared training, joint inspections, alignment of technical paperwork, and real-time data exchange. These efforts aim to enhance trust in Indian regulatory standards while ensuring that product quality and safety remain top-notch.
To safeguard the integrity of the agreement, the FTA includes strict Rules of Origin (RoO). These rules prevent products from third countries from unfairly benefiting through the UK. A digital certification system, along with active customs surveillance, ensures that only products genuinely made or substantially transformed in India receive duty-free treatment.
Altogether, this agreement not only supports India’s manufacturing and export goals but also reinforces its growing reputation as a trusted global supplier in the medical device industry.
