China’s NMPA Releases Draft Adjustments to the IVD Classification Catalogue

China’s Center for Medical Device Standards Management under the National Medical Products Administration (NMPA) recently issued a public notice seeking comments on the “Proposed Dynamic Adjustments to Selected Contents of the 'IVD Classification Catalogue.'”

Prepared in accordance with the “Working Procedures for Dynamic Adjustment of the Medical Device Classification Catalogue,” the draft was developed by the Clinical Laboratory Sub-Group of the Medical Device Classification Technical Committee. Comments are due by 1 December 2025.

The draft provides overseas manufacturers with early insight into reclassification trends that may affect product launch pathways in China. For support in preparing formal feedback, contact Cisema today.

Key Regulatory Changes Proposed in the Draft

The NMPA proposes targeted revisions to risk classes, the treatment of advanced technologies, and key terminology to improve regulatory clarity and better align classifications with clinical risk.

The following sections summarize the most relevant updates for overseas IVD manufacturers.

NMPA Plans to Revise IVD Risk Classes

The NMPA proposes recalibrating several IVD classifications to ensure that regulatory controls match both technological maturity and the clinical impact of test results.

As part of this adjustment, some routine tests used to monitor chronic diseases (such as diabetes and hypertension) with mature technologies are proposed to be reclassified from Class II to Class I. This downgrading would remove clinical-trial requirements and streamline the registration process for these products.

At the same time, the NMPA plans to upgrade assays that guide high-stakes clinical decisions. This includes products used for:

• major infectious-disease screening
• companion diagnostics
• therapeutic-drug monitoring where medications have narrow therapeutic windows

These assays would move from Class II to Class III, triggering more demanding clinical-evaluation and quality-management requirements.

New Classification Rules for Advanced Diagnostic Technologies

The draft also clarifies how modern diagnostic platforms and emerging biomarkers will be classified. Initial rules are introduced for next-generation sequencing (NGS), mass spectrometry, digital PCR, and comparable technologies. Under these rules, NGS panels used for tumor-gene mutation detection would be classified as Class III.

The NMPA further assigns initial classifications to newly recognised biomarkers with demonstrated diagnostic or monitoring relevance, such as:

• novel autoantibodies
• biomarkers associated with neurodegenerative diseases

These inclusions provide defined regulatory pathways for innovative assays that previously lacked explicit catalogue placement.

Updated Terminology to Support Clearer Intended Uses

The draft further refines terminology to support consistency during technical review. The NMPA clarifies distinctions among diagnostic aid, screening, monitoring, and prognosis, ensuring that intended-use statements align with appropriate risk classifications.

In addition, naming conventions for selected reagents are harmonized to reduce ambiguity and improve alignment between manufacturer submissions and regulatory expectations. These refinements aim to minimize misclassification and support more predictable evaluation outcomes.

Action Steps for Overseas IVD Manufacturers

The draft has operational implications for regulatory affairs, clinical affairs, R&D, and quality teams within overseas companies. A coordinated review will help prevent delays and support compliance with NMPA expectations.

Conduct a Structured Internal Review

Regulatory affairs, R&D, and clinical affairs teams should jointly compare the draft against all products marketed, registered, or planned for submission in China. Key tasks include:

• Mapping each product to its corresponding entry in the proposed catalogue
• Identifying classification changes that affect evidence requirements or dossier structure
• Reviewing intended-use statements and technical documentation for alignment with revised terminology

Adjust Registration Plans Based on Expected Reclassifications

Portfolio-planning and regulatory teams should revise China submission schedules to reflect anticipated changes. Products likely to be downgraded may warrant accelerated submission, while products expected to be upgraded may require earlier preparation of expanded clinical or performance-evaluation packages. Budgets and global launch timelines should also be adjusted to account for potential Class III obligations.

Submit Evidence-Based Feedback to the NMPA

Regulatory affairs teams should prepare evidence-based comments that directly address the proposed changes. Collaboration with a China-based regulatory partner — such as Cisema — can help refine technical justifications, interpret the draft requirements in a China-specific context, and manage exchanges with the NMPA during the comment process.

Final Thoughts: Navigating China’s Evolving IVD Regulations

The NMPA’s draft adjustments reflect a more granular, risk-based approach to IVD oversight and clearer expectations for advanced diagnostic technologies. Overseas manufacturers that assess impacts early, coordinate internal teams, and prepare China-specific evidence packages will be better positioned to maintain momentum in their registration plans.

As the revisions progress toward finalization, manufacturers will need timely, accurate interpretation and local regulatory insight to navigate reclassifications. Cisema offers the on-the-ground expertise and structured guidance needed to manage these transitions effectively. Get in touch with Cisema today for expert support in classification analysis and preparation of formal comments for submission to the NMPA.

Further Information

Explore Cisema’s China Medical Device & IVD Registration Services

References

Read the NIFDC Notice on IVD Classification Adjustments — 关于公开征求《体外诊断试剂分类目录》部分内容动态调整意见的通知 (Notice on publicly soliciting opinions on the dynamic adjustment of some contents of the “Classification Catalogue of In Vitro Diagnostic Reagents”