India to probe Chinese MedTech imports

Indian medical technology manufacturers have raised significant concerns over the growing presence of Chinese-made medical devices in the country’s healthcare sector, prompting the government to consider an inquiry and possible new regulations.

China is the second-largest supplier of medical devices to India, with a 16.4% market share in 2023-24 (worth approximately ₹11,506 crore), close behind the U.S. Concerns extend beyond direct imports, as Chinese-origin devices are often rerouted into India via countries like Hong Kong, Malaysia, and Singapore to bypass regulations. These countries are believed to be transshipment hubs for Chinese-made medical devices, helping manufacturers circumvent regulatory restrictions imposed by the Central Drugs Standard Control Organisation (CDSCO) and the Department for Promotion of Industry and Internal Trade (DPIIT).

At a recent meeting with Commerce and Industry Minister Piyush Goyal, industry leaders warned that modern devices, such as MRIs, patient monitors, and diagnostic equipment—many of which are equipped with internet connectivity and cloud-based storage—could enable unauthorized data access and pose risks to national security.

These devices, they argue, could act as digital backdoors, exposing sensitive patient and institutional data to remote exploitation and surveillance, especially since some manufacturers lack transparency in their software and firmware updates.

Executives warned that hostile entities might exploit software vulnerabilities—potentially embedding malware or surveillance tools without detection. Such tactics risk transforming critical medical infrastructure into targets for cyberespionage or other non-kinetic attacks, sometimes described as “grey zone warfare.”

Indian manufacturers are urging the government to implement mandatory security vetting, quality audits, and certifications for foreign medical imports, particularly those from China. Proposals include preferential procurement policies for domestic manufacturers, stricter tracking of origin, and enhanced R&D support, in alignment with initiatives aimed at greater self-reliance under the National Medical Devices Policy 2023.

The government has acknowledged the seriousness of these risks and announced plans to scrutinize procurement practices and create a robust regulatory regime to ensure data integrity and system resilience across India’s healthcare sector.

Ongoing policy discussions and a forthcoming government probe reflect industry calls for urgent action: to strengthen cybersecurity in medical technology, encourage indigenous innovation, and mitigate potential risks associated with foreign-manufactured devices.

USA and EU members strict regulations on medical devices from China
The United States enforces strict regulatory requirements for all imported medical devices, including those from China. The U.S. Food and Drug Administration (FDA) mandates compliance with comprehensive safety, efficacy, and labeling standards. Heightened attention from the FDA and the Cybersecurity and Infrastructure Security Agency (CISA) has led to increased scrutiny of Chinese devices, particularly regarding cybersecurity and data privacy risks in critical healthcare infrastructure. While there is no blanket ban, imported Chinese medical devices are subject to rigorous vetting, and those linked to particular security risks can face approval delays or rejections. Proposed legislation like the Biosecure Act would further tighten restrictions on technologies deemed high risk.

The European Union has implemented significant import restrictions on Chinese medical technology. In June 2025, the EU passed measures excluding Chinese medical device suppliers from most public procurement contracts valued above €5 million. For allowed contracts, winning proposals cannot consist of more than 50% China-sourced components. The policy is designed to protect EU businesses and responds to perceived discriminatory practices by China against European firms. This has led to reciprocal trade tensions, with China imposing similar restrictions on EU suppliers for its own large contracts.

Globally, several other countries have adopted regulatory or monitoring measures targeting Chinese medical technologies over concerns involving national security, data privacy, and economic interests. The EU’s new restrictions utilize the International Procurement Instrument (IPI), intended to address trade imbalances. The primary motivations for these actions are to mitigate unfair market practices, bolster cybersecurity for sensitive health data, and secure critical healthcare infrastructure.

MB Bureau