India should seek reciprocal concessions from EU under proposed FTA in medical devices sector: GTRI
The Global Trade Research Initiative (GTRI) has said that India should seek reciprocal concessions from the European Union (EU) under the proposed free trade agreement (FTA) in the medical devices sector to promote its exports. India charges zero to 10 per cent tariffs on most medical devices and a duty cut by India on medical devices without addressing EUs regulatory challenges will result in low exports but large scale imports from EU.
To achieve a fair trade deal, GTRI said India must demand reciprocity. India should cut tariff on medical devices only if the EU reduces its non-tariff barriers. It said the ongoing India-EU FTA negotiations on medical devices are asymmetrical. While the EU demands zero tariffs on medical devices from India, it maintains high regulatory barriers that hinder Indian exports difficult in the EU markets.
GTRI Founder Ajay Srivastava said the EU customs duty rates are zero, but market entry costs are substantial because of the stringent regulatory framework. Exporting to EU has become more difficult as it replaced the Medical Device Directives (EU-MDD) with the more stringent Medical Device Rules (EU-MDR). Citing an example, he said the new certification and regulatory expenses amount to 60,000-300,000 euro annually for market access of 100,000-3.75 million euro.
He further said certification approval time increased from the earlier 4-8 months to 2-3 years now. Shortage of notified bodies and auditors in the EU is leading to high certification costs. He said on account of this, Indian exporters are withdrawing from the EU market or limiting product offerings as high entry and certification costs make market participation financially unsustainable. Moreover, he said the lack of Indian participation in the Medical Device Single Audit Program (MDSAP) limits the acceptance of Indian devices in key regulated markets.
