India Government: Comprehensive Investigation of Medical Devices Imported from China

The Indian government recently announced a comprehensive investigation into the use of Chinese medical devices in the healthcare sector, with a focus on data privacy breaches and national security threats. The investigation was prompted by an inter-ministerial meeting chaired by Commerce Minister Piyush Goyal, with participation from representatives of the medical technology industry, cybersecurity experts, and the defense sector. The aim is to assess the infiltration risk of Chinese equipment within India’s medical system.

In recent years, the scale of medical device imports from China to India has experienced explosive growth. Data shows that from fiscal year 2020 to fiscal year 2025, China's medical device exports to India surged from $622 million to $1.3 billion, with a compound annual growth rate (CAGR) of 21%, far exceeding the overall growth rate of 8.8% in India's total medical device imports. Currently, China has become India's second-largest supplier after the United States, with products covering core areas such as diagnostic imaging equipment (e.g., CT, MRI), in vitro diagnostic reagents, and surgical instruments.

However, Indian industry experts point out that the expansion of Chinese equipment in the Indian market is not purely based on market competitiveness. Chinese manufacturers use a "price squeezing" strategy and circumvent regulations by transshipping through countries like Malaysia and Singapore, meaning their actual market share may be higher than official statistics. For example, in April 2025, when China launched an anti-dumping investigation on medical CT tubes imported to the US and India, the US side accused Chinese products of squeezing the survival space of local enterprises through low-price dumping—a pattern that may also exist in the Indian market.

The core controversy of the investigation stems from cybersecurity vulnerabilities in Chinese medical devices. In early 2025, the U.S. FDA and cybersecurity agencies accused China's Contec CMS8000 patient monitors of having a "hardcoded backdoor" that could transmit patient data and receive malicious firmware updates via a specific IP address (202.114.4.119). Although the industrial cybersecurity company Claroty subsequently analyzed the issue as a design flaw rather than a malicious backdoor, the incident has still sparked widespread international concerns about the security of Chinese devices.

Indian officials cited similar cases in meetings, emphasizing that Chinese devices might be used for "surveillance and espionage activities." For example, medical devices supporting IT functions (such as networked pacemakers and MRI machines) could leak patient health information through data transmission features, or even be remotely activated by malware to disrupt device operation. More critically, Chinese equipment is also widely used in Indian defense military hospitals, and data leaks could pose a direct threat to national security.

According to an official from the Indian Medical Technology Association, the competitiveness of Chinese equipment in the Indian market partially stems from its technical specifications being out of sync with global standards. China has set independent standards for some medical devices, resulting in product prices being 30%-50% lower than international brands, but with questionable safety and compatibility. For instance, ransomware attacks in the global medical industry are expected to surge by 31% by 2025, and Chinese-made equipment, due to the lack of encryption and access control mechanisms, has become a prime target for hackers. A report from HIPAA Magazine indicates that medical data is priced 50 times higher than financial data on the black market, further escalating the risk of data breaches.

The survey is expected to focus on three main areas:

Data flow audit: Verify whether Chinese equipment transmits patient data to overseas servers.

Supply chain traceability: tracking the origin of equipment components to prevent risks of technology "choke points."

Standard Compliance Review: Assess whether Chinese equipment complies with India's Information Technology Act and international cybersecurity frameworks (such as HITRUST).

If the investigation confirms the risk, India may take the following measures:

Strengthen the certification requirements for imported equipment by requiring manufacturers to provide source code audit reports.

Promote indigenous medical technology innovation and reduce dependence on Chinese equipment.

Add data security clauses to the free trade agreement to restrict transshipment dumping.

The case in India is not an isolated example. In 2025, the global healthcare industry faces multiple security challenges. Among them, generative AI increases the realism of phishing emails by 60%, making the healthcare sector a primary target; amid the US-China trade war, the United States imposes tariffs on Chinese medical devices, while China retaliates with anti-dumping investigations; the European Union promotes a “digital health passport” to simplify data sharing, whereas countries like India strengthen data localization storage requirements.

Against this backdrop, medical device security has transcended the realm of technology to become a new battleground in strategic competition between nations. Will the findings of the Indian investigation affect the medical supply chain landscape? And how can Chinese manufacturers strike a balance between cost control and safety compliance to cope with the increasingly complex international environment? Device Home will continue to closely follow these developments.