The Centre is all set to launch a formal investigation into the increasing penetration of Chinese medical devices in the Indian healthcare ecosystem, amid growing concerns over data security, potential cyber threats, and national interest.
The move comes months after i.e. in February this year when the US Food and Drug Administration (FDA) raised cybersecurity concerns over a Chinese-manufactured hospital monitoring device after vulnerabilities—allegedly including a “backdoor” function—were discovered by a cybersecurity watchdog.
Currently, India’s medical device imports from China are heavily concentrated in sectors such as diagnostic imaging equipment, in vitro diagnostic reagents, and surgical instruments. According to officials, this trend is raising red flags over the possibility of sensitive health data being misused.
The issue was deliberated at an inter-ministerial meeting earlier this month, chaired by Commerce and Industry Minister Piyush Goyal. Stakeholders from the domestic medical technology (MedTech) industry were also present to provide their inputs.
China is currently India’s second-largest source of medical device imports, after the United States. Imports from China have surged from $622 million in FY20 to $1.3 billion in FY24, growing at a compound annual growth rate (CAGR) of 21%. By contrast, overall medical device imports have grown at a more modest CAGR of 8.8% during the same period.
“The health data collected by Chinese-manufactured devices, particularly those that are digitally enabled, could be exploited for surveillance or espionage. Given the strained geopolitical ties, there are apprehensions that malware or hidden codes embedded in such devices could be remotely activated,” sources familiar with the discussions said.
He added that such vulnerabilities pose a serious national security concern, particularly as Chinese-made devices are increasingly deployed across sensitive sectors, including defence.
The sources said that the government has sought additional data from the industry and a detailed inquiry is expected to begin shortly. “From compact pacemakers to large-scale MRI systems, Chinese devices across the spectrum are being scrutinised for cybersecurity risks,” said the sources.
They said that the industry experts also raised concerns about the alleged rerouting of Chinese medical equipment through third countries with which India has free-trade agreements, such as Malaysia, Singapore, and Hong Kong, in order to circumvent regulatory scrutiny. “Trans-shipment data shows a significant spike in imports from these countries, which strongly indicates dumping practices,” said the sources.
If this trend persists, China could surpass the United States to become India’s largest exporter of medical devices by FY26, they said.
China’s rapid ascent in India’s MedTech space is largely driven by its pricing advantage and regulatory divergences. “Unlike many global players, Chinese manufacturers often do not adhere to international regulatory frameworks. Their domestic standards are not harmonised with those of the US or EU, which allows them to undercut prices,” said a senior industry analyst, according to a media report.
