Indian medical device manufacturers have raised alarms over the increasing influx of Chinese-made equipment in the country’s healthcare ecosystem. The rising dependence on these imports—especially in critical technologies like MRIs, diagnostic tools, and patient monitoring systems—has led to escalating concerns around data security and regulatory compliance.
According to recent trade data, China emerged as the second-largest exporter of medical devices to India in FY 2023–24, capturing a 16.4% market share valued at approximately ₹11,500 crore—just behind the United States. However, officials and industry experts have highlighted that Chinese-origin devices are often routed through third countries like Hong Kong, Singapore, and Malaysia to avoid direct regulatory scrutiny.
At a recent industry consultation led by Commerce and Industry Minister Piyush Goyal, stakeholders emphasized the potential cybersecurity risks posed by smart medical devices equipped with internet connectivity and cloud storage. Experts warned that devices lacking transparent software updates or secure firmware could become channels for remote data breaches, malware insertion, or unauthorized access—threats that could compromise patient privacy and institutional safety.
These concerns have reignited calls for tighter regulatory oversight. Indian manufacturers are urging the government to enforce mandatory security audits and certification processes, especially for imported equipment. Proposals under discussion include origin tracking, procurement preferences for domestic suppliers, and expanded support for R&D in the medtech sector, aligned with the objectives of the National Medical Devices Policy 2023.
Internationally, both the United States and European Union have already taken steps to address similar challenges. The U.S. FDA, in coordination with the Cybersecurity and Infrastructure Security Agency (CISA), maintains strict controls on imported medical technologies, particularly those linked to cybersecurity vulnerabilities. Meanwhile, the EU recently enacted restrictions that limit Chinese firms from winning public contracts exceeding €5 million and require lower dependence on China-sourced components in successful bids.
The Indian government has acknowledged the urgency of the issue and is reportedly preparing a comprehensive review of medical technology procurement and import practices. The aim is to strike a balance between national security, fair trade, and healthcare modernization—while ensuring that Indian patients and hospitals remain protected from potential foreign exploitation.
As policy discussions continue, the spotlight remains firmly on building a more secure, self-reliant, and innovation-driven medtech ecosystem in India.
Source: Medical Buyer