2026 First Medical Device Product Classification Results Released

On June 22, 2026, the National Institutes for Food and Drug Control (NIFDC) — also serving as the NMPA Medical Device Standards Management Center — released the "2026 First Medical Device Product Classification Results Summary."

A total of 206 medical device products were classified in this summary:

Recommended as Class III medical devices: 32 products

Recommended as Class II medical devices: 50 products

Recommended as Class I medical devices: 94 products

Recommended not to be registered separately: 4 products

Recommended not to be regulated as medical devices: 26 products

Selected Representative Products

This classification batch features a number of innovative products with notable technological highlights:

Class III (high-risk) examples include: a spatial transcriptomics gene expression kit for tumor molecular subtyping; a sarcoma organoid drug sensitivity test kit based on patient-derived tumor tissue; a free sulfhydryl detection reagent that uses urinary biomarkers to assess HPV-related precancerous risk; and multiple fluorescence in situ hybridization (FISH) probe reagents for precision diagnosis of lymphomas, leukemias, and soft tissue sarcomas (e.g., MDM2 gene amplification probe, EWSR1 gene break-apart probe, and CBFB/MYH11 fusion gene probe).

Class II (moderate-risk) examples include: a 5-metabolite assay kit (LC-MS/MS) for heart failure risk assessment (acetyl-L-carnitine, choline, etc.); a fibroblast growth factor 21 (FGF21) assay kit for adjunctive diagnosis of non-alcoholic fatty liver disease; a galactose-deficient IgA1 detection kit for IgA nephropathy; and a chemokine 4 (CXCL4) assay kit for adjunctive diagnosis of depression.

Class I (low-risk) products, totaling 94, are primarily routine staining solutions, immunohistochemistry auxiliary reagents, and FISH auxiliary probes, providing foundational support for pathological diagnosis.

Important Note: These classification results are based on current regulatory policies, the In Vitro Diagnostic Reagent Classification Rules, and the In Vitro Diagnostic Reagent Classification Catalog, derived from comprehensive research based on current scientific understanding and consensus. The summary results do not constitute recognition of product safety and efficacy, but serve only as a reference for medical device registration or filing. Product descriptions and intended uses are provided for determining regulatory attributes and categories, and do not represent complete registration or filing content.

This classification summary provides important guidance for medical device companies in R&D positioning and registration strategy, particularly offering direct clarity on regulatory pathways for innovative IVD products.