Reciprocity Is Key To India’s Talks With EU On Medical Devices 

India’s ongoing Free Trade Agreement talks with the EU on medical devices appear asymmetrical. While the EU demands zero tariffs on medical devices from India, it maintains high regulatory barriers, making Indian exports to the region challenging.

Currently, India charges 0-10% tariffs on most medical devices. Cutting tariffs without addressing the regulatory challenges will likely result in low exports and a surge in imports from the EU. 

To achieve a fair trade deal, India must demand reciprocity — cutting tariffs on medical devices only if the EU reduces its non-tariff barriers. India also needs to make regulatory changes to make its medical devices more acceptable in developed countries, as recommended by the Parliament Committee on Health.

India’s medical devices sector is growing steadily, helping reduce the reliance on imports. In 2024, exports were $2.3 billion, while imports stood at $4.7 billion. The EU is an important market for India, with exports of $580 million and imports of $1.15 billion. 

Although the EU has zero customs duties, market entry costs are significant because of its stringent regulatory framework. Exporting to the EU has become increasingly difficult since it has replaced the Medical Device Directives with the more stringent Medical Device Rules. For example, certification and regulatory costs now range from €60,000 to €300,000 annually for market access worth €100,000 to €3.75 million. Certification approval times have also increased from 4-8 months to 2-3 years. Additionally, the shortage of notified bodies and auditors in the EU has led to high certification costs. As a result, Indian exporters are withdrawing from the EU market or limiting product offerings as high entry and certification costs are making market participation financially unsustainable.

While the EU and other developed markets impose stringent regulations, India’s policies further complicate compliance for Indian exporters. India does not have Mutual Recognition Agreements with major markets like the EU and the US, which necessitates fresh regulatory assessments, increasing costs and delays in market access. 

International regulators rely on ISO 13485 for quality, the Indian regulator Central Drugs Standard Control Organisation mandate compliance with Schedule 5 of the Indian Medical Device Rules, based on the Bureau of India Standards. This creates challenges for India in negotiating MRAs with foreign regulators. Indian manufacturers have to undergo multiple audits, which adds to costs and time delays. 

Moreover, India’s lack of participation in the Medical Device Single Audit Program limits the acceptance of Indian devices in these regulated markets. MDSAP allows manufacturers to be audited once for multiple markets, including Australia, Brazil, Canada, Japan, and the US.

To facilitate exports in the EU and other major markets, India must implement several key reforms. Firstly, the CDSCO should formally recognise ISO 13485 as an alternative to Schedule 5 in the Indian MDR for Indian Manufacturers. This alignment with global standards will make it easier to negotiate MRAs with key markets. Secondly, India should pursue MRAs with the EU, the US and other regulated markets based on ISO harmonised standards and recognise third-party notified Conformity Assessment Bodies accredited under the International Accreditation Forum. This will reduce market access costs, eliminate redundant regulatory reviews, and expedite the approval processes for Indian medical devices.

Thirdly, India needs to enhance cross-equivalence mapping and recognition of International Certification for Medical Devices and ICMED Plus certifications, already aligned with ISO standards and accredited under the IAF system. This would facilitate faster acceptance of Indian medical devices in international markets. India also should integrate into the Medical Device Single Audit Program, allowing Indian manufacturers to gain recognition from regulators like the US FDA, Health Canada, Brazil, and others.

CDSCO should recognise MDSAP certification as partial compliance, allowing desk-based technical file reviews instead of redundant audits.

Finally, CDSCO should conduct an analysis by cross-comparing Indian medical device regulations with international standards to identify gaps. A roadmap should be developed to gradually integrate global best practices and establish fast-track approval processes for manufacturing and import licenses. By implementing these reforms, India can significantly enhance the global acceptance of its medical devices, reduce regulatory bottlenecks, and increase exports to high-value markets like the EU, US, and APAC.

In negotiations with the EU, India should not agree to lower tariffs until the regulatory barriers are addressed. Strategic nominal tariff protection is essential to support domestic manufacturing. Both the US and China maintain high non-tariff measures on medical devices to protect their industries, and India should adopt a similar approach to ensure long-term healthcare security.

The EU must simplify approval processes for Indian manufacturers certified under ICMED or ICMED Plus, aligning with ISO standards after doing a cross-mapping exercise with the CE marking – the certification that a product has met EU health, safety, and environmental requirements.

Additionally, the EU should introduce a transparent pricing mechanism to control high certification costs. Other regulated markets like Japan, Canada, and Australia have structured regulatory systems with lower compliance costs than the EU.
Finally, the EU should implement electronic verification for products labelled as ‘EU-made’ to ensure they genuinely manufactured in the EU. This would prevent third-country manufacturers from relabeling products as EU-made while actually producing them in China, Taiwan, or Indonesia.