Key Points
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...
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"...
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, GTRI said.. "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 said...
Top medical devices, along with import value, are apparatus for diagnostic lab analysis Polarimeters, Refractometers, and spectrometers (USD 63.83 million); X-ray and other radiotherapy apparatus (USD 52 million); diagnostic/lab reagents (USD 29.18 million)...
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