Delayed regulatory approval in UK impacts medical devices exports

New Delhi : Prolonged regulatory approval processes in the UK impact India’s exports of medical devices to the British market, think tank GTRI said on Wednesday.

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. “The MRA would reduce regulatory compliance and audit requirements, potentially enhancing India’s exports,” Global Trade Research Initiative (GTRI) Co-Founder Ajay Srivastava said. The suggestion assumes significance as both the countries are negotiating a free trade agreement and this sector is an important part of that. The existing zero import duties on medical devices in the UK imply no direct tariff-related advantages for India under the FTA, it said. This means, India’s medical devices industry does not gain tariff concessions, which are a typical benefit in such trade agreements, it said adding “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.