IVD Clinical Trial Exemption 2025: NMPA Catalogue Update

IVDs with clinical trial exemptions in China have been expanded with a recent 2025 NMPA catalogue update. The updated Catalogue of In Vitro Diagnostic Reagents Exempt from Clinical Trials (2025) took effect immediately upon its release by China’s National Medical Products Administration (NMPA) on June 24, 2025. The number of clinical trial exempt IVD products has been expanded from 423 to 445, including 418 Class II and 27 Class III reagents.

Core Changes and Implementation Timeline

Change Type Quantity Representative Products Remark Newly Added 60 items GP73 (Class III), Total-P1NP, ST2 Protein Detection (Class II) Oncology, cardiovascular, reproductive health Deleted 45 items β2 microglobulin, pepsinogen, various media Obsolete or reclassified to Class I (which does not require clinical trials) Split / Refinement 5 categories Troponin I/T, immunoglobulin, interleukin series Improved clinical precision

The Catalogue excludes exemptions for patient self-testing and neonatal testing products, reinforcing cautious regulatory measures for special populations.

Impact on Overseas Manufacturers

For overseas IVD manufacturers, inclusion in the exemption catalog can influence time, financial, and strategic considerations in the registration process:

Accelerated Market Access
(1) Time Cost: Exemption shortens registration cycles by 6–12 months.
(2) Financial Cost: May reduce the need for additional China-specific clinical trials.
(3) Opportunity Cost: Supports market access planning, especially for IVDs with short life cycles.

Common Misconceptions & Special Notes

Exemption from Clinical Trial ≠ Exemption from Evidence:
Per Article 37 of the Regulations on Registration and Record-Filing of In Vitro Diagnostic Reagents, exempt products must still demonstrate safety and efficacy through methods like comparative studies. Although clinical trials are not required, manufacturers must still provide supporting evidence to demonstrate product safety and efficacy. Key requirements:
(1) Submit clinical sample evaluation reports covering intended use and interference factors.
(2) Sample sources must be traceable, with complete age, gender, and clinical background information.
(3) Comparative data against marketed products must meet statistical requirements.
Positioning Challenges Due to Classification Changes
Manufacturers should be cautious when interpreting category changes in the new catalog, as classification logic and terminology have been refined:
(1) Significant logic differences exist between old and new classification systems; do not rely solely on product name matching.
(2) Reconfirm product categories against the IVD Classification Catalogue.
(3) Pay special attention to refined product categorizations (e.g., Troponin I subdivided into high-sensitivity and cardiac types).
Compliance Boundaries for Intended Use
Strictly adhere to the scope defined in the Catalogue:
Intended use statements must align precisely with catalog listings. Misrepresentation or over-extension of claims could lead to non-compliance:
(1) No Extensions: e.g., growth hormone reagents must state "not for dynamic monitoring of malignant tumor patients."
(2) Avoid Ambiguous Claims: e.g., vascular endothelial growth factor detection must be limited to approved indications.
(3) Include Exclusion Clauses: e.g., β-HCG reagents must state "not for tumor diagnosis."
Sustained Compliance with Production Quality Systems
Even though the product is exempt from clinical trials, the quality requirements remain unchanged:
(1) Must still comply with China GMP requirements.
(2) If selected for NMPA factory audit, the product must pass as part of normal regulatory oversight.
(3) The Legal Agent (local authorized representative) assumes responsibility for post-market supervision.

Strategies for Overseas Manufacturers

Immediate Action: Cross-check your product line with the 2025 exemption catalogue.
Precision Positioning: Reclassify products under new rules and intended uses.
Leverage Expertise: Engage regulatory consultants like Cisema for guidance.

Further Information

To read the original announcement about the 2025 Catalogue of In Vitro Diagnostic Reagents Exempt from Clinical Trials released by the NMPA, please click here.

If you are an IVD manufacturer with questions about how the 2025 exemption catalogue affects your product registration in China, please contact Cisema.

Here is the complete list of IVDs exempted from clinical trials (2025).

Appendix: List of Changes

Newly Added Products (60 items)

(1) Herpes Simplex Virus Type II (HSV II) IgG Antibody Detection Reagent
(2) Rubella Virus IgG Antibody Detection Reagent
(3) Golgi Protein 73 (GP73) Detection Reagent
(4) Type III Procollagen N-Terminal Peptide (PⅢ-NP) Detection Reagent
(5) Type I Collagen Amino-Terminal Propeptide (Total-P1NP) Detection Reagent
(6) S100-β Protein Detection Reagent
(7) β-Collagen Specific Sequence Detection Reagent
(8) κ Light Chain (Kappa Light Chain) Detection Reagent
(9) λ Light Chain (Lambda Light Chain) Detection Reagent
(10) Free κ Light Chain (Free Kappa Light Chain) Detection Reagent
(11) Free λ Light Chain (Free Lambda Light Chain) Detection Reagent
(12) Calprotectin Detection Reagent
(13) Heparin-Binding Protein (HBP) Detection Reagent
(14) Calcitonin (CT) Detection Reagent
(15) Glial Fibrillary Acidic Protein (GFAP) Detection Reagent
(16) Chitinase-3-Like Protein 1 Detection Reagent
(17) Lactoferrin Detection Reagent
(18) Gastrin-17 (G-17) Detection Reagent
(19) Fibronectin Detection Reagent
(20) Fetal Fibronectin (fFN) Detection Reagent
(21) Krebs von den Lungen-6 (KL-6) Detection Reagent
(22) Angiotensin I Detection Reagent
(23) Angiotensin II Detection Reagent
(24) Thrombomodulin Detection Reagent
(25) Insulin-Like Growth Factor I (IGF-I) Detection Reagent
(26) Adiponectin Detection Reagent
(27) Soluble Suppression of Tumorigenicity 2 (ST2) Detection Reagent
(28) 1,5-Anhydro-D-Sorbitol Detection Reagent
(29) Reverse Triiodothyronine (rT3) Detection Reagent
(30) Free Testosterone Detection Reagent
(31) Anti-Müllerian Hormone (AMH) Detection Reagent
(32) Inhibin A Detection Reagent
(33) Inhibin B Detection Reagent
(34) Bone-Specific Alkaline Phosphatase Detection Reagent
(35) Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Detection Reagent
(36) Glutamate Dehydrogenase Detection Reagent
(37) Matrix Metalloproteinase-3 (MMP-3) Detection Reagent
(38) Small Dense Low-Density Lipoprotein Cholesterol Detection Reagent
(39) Red Blood Cell Folate Detection Reagent
(40) Vitamin A Detection Reagent
(41) Vitamin E Detection Reagent
(42) Olanzapine Detection Reagent
(43) Risperidone Detection Reagent
(44) Anti-Ribosomal P Protein Antibody Detection Reagent
(45) Anti-Centromere Protein B Antibody Detection Reagent
(46) Anti-Nuclear Membrane Glycoprotein 210 Antibody Detection Reagent
(47) Anti-Intestinal Goblet Cell Antibody Detection Reagent
(48) Anti-Phospholipase A2 Receptor Antibody Detection Reagent
(49) Anti-Pancreatic Acinar Cell Antibody Detection Reagent
(50) Group B Streptococcus Chromogenic Medium/Culture Fluid
(51) Total IgE Detection Reagent
(52) Anti-Factor Xa Detection Reagent
(53) Absolute Counting Microsphere Reagent
(54) Sperm DNA Fragmentation Detection Reagent
(55) Sperm Acrosin Detection Reagent
(56) Complement C1q Detection Reagent
(57) Vascular Endothelial Growth Factor Detection Reagent
(58) Specific Growth Factor Detection Reagent
(59) α-Interferon (IFN-α) Detection Reagent
(60) γ-Interferon (IFN-γ) Detection Reagent

Deleted Products (45 items)

(1) β2-Microglobulin (β2-MG) Detection Reagent
(2) Pepsinogen (PG) I Detection Reagent
(3) Pepsinogen (PG) II Detection Reagent
(4) Elution Buffer for Glycated Hemoglobin Analysis
(5) Occult Blood Detection Reagent
(6) Follicle-Stimulating Hormone Detection Reagent
(7) γ-Glutamyltransferase Isoenzyme Detection Reagent
(8) Tobramycin Detection Reagent
(9) Quinidine Detection Reagent
(10) Anti-Sm/RNP Antibody Detection Reagent
(11) Anti-Chronic Inflammatory Bowel Disease Antibody Detection Reagent
(12) Anti-Proliferating Cell Nuclear Antigen (PCNA) Antibody Detection Reagent
(13) Anti-Skeletal Muscle Antibody Detection Reagent
(14) Escherichia Coli Identification Urine Culture Dip Slide
(15) Urinary Pathogen Identification Medium
(16) Cefixime-Potassium Tellurite Inhibitor
(17) Sabouraud Dextrose Agar Medium
(18) Eosin Methylene Blue Agar Medium
(19) SS Agar Medium
(20) MacConkey Agar Medium
(21) Sorbitol MacConkey Medium
(22) China Blue Agar Medium
(23) Hektoen Enteric Agar Medium
(24) WS Agar Medium
(25) XLD Agar Medium
(26) HE Agar Medium
(27) Gentamicin Agar Medium
(28) Neisseria Gonorrhoeae Medium
(29) Modified Thayer-Martin (MTM) Selective Agar Medium
(30) Thayer-Martin (TM) Gonococcus Medium
(31) Gonococcus Culture Dip Slide
(32) Haemophilus Chocolate Agar Selective Medium
(33) Columbia Blood Agar Medium
(34) Streptomycin Lauryl Sulfate Tellurite Agar Medium
(35) Thiosulfate-Citrate-Bile Salts-Sucrose (TCBS) Agar Medium
(36) Cystine-Lactose-Electrolyte-Deficient (CLED) Agar Medium
(37) Mannitol Salt Agar Medium
(38) Baird-Parker Agar Medium
(39) Motility Test Medium
(40) Brucella Blood Agar (BBA)
(41) Anaerobic Blood Agar Medium
(42) Trichomonas Medium
(43) Biphasic Chromogenic Body Fluid Culture Bottle
(44) Sperm Acrosin Activity Detection Reagent
(45) Sperm Concentration Detection Reagent

Split / Refinement

(1) "Troponin I Detection Reagent" split into "High-Sensitivity Troponin I Detection Reagent" and "Cardiac Troponin I Detection Reagent".
(2) "Troponin T Detection Reagent" split into "High-Sensitivity Troponin T Detection Reagent" and "Cardiac Troponin T Detection Reagent".
(3) "Immunoglobulin Detection Reagent" split into "Immunoglobulin A (IgA) Detection Reagent", "Immunoglobulin G (IgG) Detection Reagent", and "Immunoglobulin M (IgM) Detection Reagent".
(4) "Insulin-Like Growth Factor Binding Protein Detection Reagent" split into "IGFBP-1 Detection Reagent" and "IGFBP-3 Detection Reagent".
(5) "Interleukin Detection Reagent" split into "IL-1β", "IL-2", "IL-2 Receptor", "IL-5", "IL-6", "IL-8", "IL-10", "IL-12p70", and "IL-17 Detection Reagents".