China Tightens Medical Device Post-Market Surveillance with New Risk Evaluation and Report Review Rules

On April 8 and April 10, 2026, the National Center for Adverse Drug Reaction Monitoring issued two official notices in China — “Notice on the Release of Guidelines on Risk Evaluation of Adverse Events for Medical Device Registrants (2026 Revised Version)” and “Notice on Issuing the Guidelines for the Review of Periodic Risk Evaluation Report (Trial).”

Each guideline took effect on its date of issuance, introducing more structured requirements for China medical device post-market surveillance and adverse event risk evaluation.

Updated China Medical Device Risk Evaluation Requirements

The first notice introduces a revised framework for how registrants must conduct adverse event risk evaluations, replacing “Announcement No. 78 of 2020.” The update aligns terminology and processes withcurrent risk management principles and strengthens post-market oversight expectations.

Refined Triggering Conditions for Risk Evaluation

A key focus of the revision is defining when registrants must initiate risk evaluation.

Evaluations are required when:

• Potentially unacceptable safety risks are identified through individual case assessments or aggregated adverse event analysis
• Monitoring authorities at provincial level or above require further investigation

The guideline replaces the previous term “unreasonable risk” with “unacceptable safety risk,” improving alignment with international risk management frameworks. Notably, “signal handling” is no longer listed as a standalone trigger condition but is incorporated into broader aggregated data analysis requirements.

Defined Scope of Evaluation Activities

Beyond triggering conditions, the guideline standardizes how evaluations should be performed. Registrants are expected to follow astructured process that includes:

• Adverse event investigation and verification
• Monitoring data and literature analysis
• Assessment of additional risk signals and related information
• Product testing where necessary
• Comprehensive risk analysis and evaluation
• Implementation of appropriate risk control measures

Adjustments to Risk Control and Reporting Mechanisms

The revision also refines the boundary between riskevaluation and other regulatory actions. “Recall” has been removed from the list of risk control measures, as it remains governed under the “Medical Device Recall Management Measures.”

At the same time, reporting pathways have been streamlined. While evaluation reports are still required, submission is now managed through China’s national adverse event monitoring information system, rather than through standalone provisions in the guideline.

New Review Guidelines for Periodic Risk Evaluation Reports

Building on the revised evaluation framework, the second notice addresses how periodic risk evaluation reports are reviewed. For the first time, it introduces a dedicated set of review criteria, supporting Article 40 of the “Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events” (Order No. 1, 2018).

The guideline establishes consistent review standards acrossthree core areas:

• Submission forms
• Report format
• Report content

This alignment reduces variability across reviewingauthorities and provides clearer expectations for registrants preparing submissions.

Defined Rejection Scenarios and Common Deficiencies

To further improve transparency, the guideline outlines four categories of common rejection scenarios:

• Rationality — such as inconsistent data timelines
• Compliance — including non-compliant language
• Completeness — missing required data or attachments
• Otherissues — administrative or formatting deficiencies

These categories help registrants anticipate how reports will be assessed and where deficiencies are most likely to arise.

No Change to Existing Report Templates

Although review expectations have become more stringent,existing templates and writing requirements remain unchanged. Registrants can continue using current formats, provided that submissions fully meet the updated review criteria.

Impact and Compliance Considerations for Foreign Manufacturers

Taken together, these updates create a more structured and tightly enforced framework for China medical device post-market surveillance. The changes affect both how risk evaluations are conducted and how periodic reports are assessed, raising the overall compliance threshold.

Increased Scrutiny on Report Quality and Consistency

With the introduction of formal review criteria, authorities will apply more consistent and detailed scrutiny across submissions.

Foreign manufacturers should expect:

• Greater likelihood of rejection for minor inconsistencies
• Higher expectations for data integrity, completeness, and traceability
• Stricter alignment with submission formats and technical requirements

Operational Implications for Risk Evaluation Activities

At the same time, revised risk evaluation requirements place greater demands on internal vigilance systems. Registrants must be able to identify risk signals promptly and conductstructured, data-driven evaluations in line with regulatory expectations.

Recommended Actions for Foreign Manufacturers

To maintain compliance withChina medical device regulations, companies should:

• Review updated terminology and triggering conditions for adverse event risk evaluation
• Update internal vigilance and post-market surveillance procedures
• Train regulatory and safety teams on revised workflows and expectations
• Perform rigorous pre-submission quality checks on periodic risk evaluation reports
• Coordinate closely with local agents to ensurealignment with national and provincial regulatory expectations

Proactive alignment across these areas will be critical toreducing submission risk and maintaining compliance.

Final Thoughts: A New Compliance Standard for Medical Device Vigilance inChina

These updates point to a moredeliberate tightening of China’s medical device post-market surveillance system, where expectations are not only clearer but also more consistently enforced. By defining how risk evaluations should be conducted and how reports will be reviewed, regulators are reducing ambiguity while raising the bar for execution.

For foreign manufacturers, the shift is less about understanding the rules and more about operationalizing them. Aligning global vigilance systems with China-specific requirements, particularly around data integrity, documentation, and reporting workflows, will be critical under closer regulatory scrutiny.

This is where targeted, on-the-ground expertise becomes essential. With deep experience in China medical device regulations, Cisema supports international manufacturers in translating regulatory requirements into practical processes, from risk evaluation strategy to report preparation and submission, helping reduce compliance risk while maintaining uninterrupted market access.

For companies seeking to strengthen post-market surveillance systems and ensure compliance with China’s evolving requirements, contact Cisema today.

Further Information

• Learn more about Cisema’s post-market surveillance (PMS) services in China
• Explore medical device regulatory consulting services in China from Cisema

References

• Review “Notice on the Release of Guidelineson Risk Evaluation of Adverse Events for Medical Device Registrants (2026 Revised Version)”
• Review “Notice on Issuing the Guidelines for the Review of Periodic Risk Evaluation Reports (Trial)”