Background A late-stage medical device manufacturer faced a major regulatory setback after the FDA questioned their premarket cybersecurity submission. Their Software Bill of Materials (SBOM) listed nearly 100 unfixed vulnerabilities spanning embedded firmware, cloud...
Meeting China’s CFDA Cybersecurity Law (CSL) Requirements
Summary
China’s CFDA Guidelines under the Cybersecurity Law (CSL) require medical devices to undergo formal cybersecurity risk assessment and postmarket monitoring. ELTON helps manufacturers meet these requirements by building a digital twin of each product, performing architecture-aware vulnerability analysis, documenting security controls, and maintaining continuous postmarket surveillance—all in a regulatory-aligned, audit-ready format.
As the global regulatory landscape tightens around cybersecurity, medical device manufacturers looking to market in China must navigate an increasingly structured set of cybersecurity requirements. Since the enactment of China’s Cybersecurity Law (CSL) and the 2018 CFDA Principles on Guiding Technology Examination of Medical Device Cybersecurity Registration, the Chinese regulatory authority, now operating under the National Medical Products Administration (NMPA), formerly CFDA, requires that all connected medical devices undergo formal cybersecurity risk assessment and registration review.
Unlike in the past, cybersecurity is now treated as a core element of product safety and performance in China. For manufacturers, this means embedding cybersecurity into both premarket registration and postmarket product monitoring. ELTON helps device companies meet these requirements with an architecture-aware, defensible cybersecurity platform tailored to support Chinese regulatory expectations.
Overview of CFDA Cybersecurity Requirements
Under the CFDA Guidelines issued in 2018, medical device submissions in China must include:
-
A network security description of the product
-
A risk assessment report evaluating threats, vulnerabilities, and potential impact
-
A list of security protection measures
-
An explanation of data transmission, storage, and access controls
-
Ongoing postmarket monitoring procedures
These requirements apply to any device that contains software, connects to a network, or transfers patient or operational data electronically. The CFDA expects risk assessments to consider both software composition (e.g., third-party components) and system architecture (e.g., communication interfaces, trust zones, access controls).
How ELTON Helps Meet CFDA Cybersecurity Registration Requirements
ELTON is designed to align with regulatory frameworks like the CFDA’s by automating the discovery, triage, and justification of cybersecurity vulnerabilities throughout the product lifecycle.
1. Digital Twin and Architecture Modeling
ELTON builds a full system representation, or digital twin, of the medical device, capturing embedded software, communication paths, external interfaces, and data flows. This allows manufacturers to generate the required network security architecture diagrams and interface descriptions directly from the platform.
2. Vulnerability and Risk Assessment
ELTON performs continuous analysis of vulnerabilities using inputs from SBOMs, penetration testing, SAST/DAST, and real-time threat feeds. Each vulnerability is analyzed in context, based on attack paths, reachability, and chained exploit potential, to produce a prioritized, risk-based assessment aligned with the CFDA’s required evaluation content.
3. Security Control Documentation and Traceability
As required under CFDA, manufacturers must document what security controls are in place and whether they effectively reduce risk. ELTON automatically maps mitigations to architecture components, tracks unresolved issues, and stores justification when vulnerabilities do not require remediation, ensuring clear traceability for review by Chinese authorities.
4. Postmarket Surveillance and Updates
China’s CSL also expects manufacturers to monitor product cybersecurity postmarket and update threat assessments as new CVEs are disclosed. ELTON’s continuous monitoring ensures that products remain in compliance with this expectation, with living records of vulnerability status and system posture that can be exported for ongoing compliance and audits.
Succeeding in China’s Regulatory Environment
For medical device manufacturers entering or maintaining a presence in China, cybersecurity compliance is no longer optional. The CFDA Guidelines require detailed, product-specific documentation that goes well beyond generic checklists. ELTON provides a complete solution for meeting these cybersecurity registration requirements, covering both premarket risk evaluation and postmarket surveillance, with defensible outputs that support submission, inspection, and lifecycle compliance under China’s Cybersecurity Law.
By using ELTON, manufacturers gain a scalable, transparent, and regulatory-aligned approach to managing cybersecurity risk reducing regulatory delays, lowering long-term cost, and ensuring safe access to the Chinese market.
