Global Trade Research Initiative (GTRI) has said that prolonged regulatory approval processes in the UK impact India's exports of medical devices to the British market. To promote exports of these devices, it said India should negotiate a Mutual Recognition Agreement (MRA) to expedite the entry of these equipment into the UK market, particularly for devices with CDSCO (Central Drugs Standard Control Organisation) licence or Quality Council of India's Indian Certification of Medical Devices (ICMED) certification. It said the MRA would reduce regulatory compliance and audit requirements, potentially enhancing India's exports. The suggestion assumes significance as both the countries are negotiating a free trade agreement and this sector is an important part of that.
GTRI said the existing zero import duties on medical devices in the UK imply no direct tariff-related advantages for India under the FTA. This means, India's medical devices industry does not gain tariff concessions, which are a typical benefit in such trade agreements. It also said even with zero tariffs in the UK, India's medical device exports to the UK are limited due to prolonged regulatory approval processes in the UK. It added that British regulations permit products to be labelled as 'Made in UK' even if they are merely marketed there, not manufactured.
It also said this is allowed under the current UK Medical Device Regulations, where a product can be labelled with a 'Legal Manufacturer' from the UK, even if the actual production does not occur there. Post-FTA, this may create a risk of increased imports due to duty cuts and lax product- specific rules of origin, potentially impacting India's growing medical device sector. It also said that India might consider duty reductions in the proposed trade pact only on products where India's exports are high and it has a competitive export advantage, assessed at the tariff line level.
