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

On April 8 and April 10, 2026, the National Center forAdverse Drug Reaction Monitoring issued two official notices in China — “Noticeon the Release of Guidelines on Risk Evaluation of Adverse Events for MedicalDevice Registrants (2026 Revised Version)” and “Notice on Issuing theGuidelines 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-marketsurveillance and adverse event risk evaluation.

Updated China Medical Device Risk Evaluation Requirements

The first notice introduces a revised framework for howregistrants 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 oversightexpectations.

Refined Triggering Conditions for Risk Evaluation

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

Evaluations are required when:

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

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

Defined Scope of Evaluation Activities

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

• Adverseevent investigation and verification
• Monitoringdata and literature analysis
• Assessmentof additional risk signals and related information
• Producttesting where necessary
• Comprehensiverisk analysis and evaluation
• Implementationof 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 thelist of risk control measures, as it remains governed under the “Medical DeviceRecall Management Measures.”

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

New Review Guidelines for Periodic Risk Evaluation Reports

Building on the revised evaluation framework, the secondnotice addresses how periodic risk evaluation reports are reviewed. For thefirst time, it introduces a dedicated set of review criteria, supportingArticle 40 of the “Measures for the Monitoring and Re-evaluation of MedicalDevice Adverse Events” (Order No. 1, 2018).

The guideline establishes consistent review standards acrossthree core areas:

• Submissionforms
• Reportformat
• Reportcontent

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

Defined Rejection Scenarios and Common Deficiencies

To further improve transparency, the guideline outlines fourcategories 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 reportswill 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 cancontinue using current formats, provided that submissions fully meet theupdated review criteria.

Impact and Compliance Considerations for Foreign Manufacturers

Taken together, these updatescreate a more structured and tightly enforced framework for China medicaldevice post-market surveillance. The changes affect both how risk evaluationsare conducted and how periodic reports are assessed, raising the overallcompliance threshold.

Increased Scrutiny on Report Quality andConsistency

With the introduction of formalreview criteria, authorities will apply more consistent and detailed scrutinyacross submissions.

Foreign manufacturers should expect:

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

Operational Implications for Risk Evaluation Activities

At the same time, revised riskevaluation 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 triggeringconditions for adverse event risk evaluation
• Update internal vigilance and post-marketsurveillance procedures
• Train regulatory and safety teams on revisedworkflows and expectations
• Perform rigorous pre-submission quality checkson 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 surveillancesystem, where expectations are not only clearer but also more consistentlyenforced. By defining how risk evaluations should be conducted and how reportswill be reviewed, regulators are reducing ambiguity while raising the bar forexecution.

For foreign manufacturers, the shift is less aboutunderstanding the rules and more about operationalizing them. Aligning globalvigilance systems with China-specific requirements, particularly around dataintegrity, documentation, and reporting workflows, will be critical undercloser regulatory scrutiny.

This is where targeted, on-the-ground expertise becomesessential. With deep experience in China medical device regulations, Cisemasupports international manufacturers in translating regulatory requirementsinto practical processes, from risk evaluation strategy to report preparationand submission, helping reduce compliance risk while maintaining uninterruptedmarket access.

For companies seeking to strengthen post-market surveillancesystems and ensure compliance with China’s evolving requirements, contactCisema 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)”