NMPA Releases 2025 IVD Clinical Trial Exemption Catalogue

China has expanded the range of in vitro diagnostic (IVD) reagents exempt from clinical trials, potentially reducing the time and cost required for registration of eligible products.

On June 24, 2025, China’s National Medical Products Administration (NMPA) released the updated Catalogue of In Vitro Diagnostic Reagents Exempt from Clinical Trials (2025), which took effect immediately.

The revised catalogue expands the number of exempt IVD products from 423 to 445, comprising 418 Class II and 27 Class III IVD reagents.

Preparing for IVD Registration in China? Contact Cisema for tailored support with IVD registration in China and clinical development, from clinical trial strategy and evidence planning to regulatory submissions.

What Changed in China’s 2025 IVD Clinical Trial Exemption Catalogue?

The 2025 catalogue introduces new exemptions, removes products from the previous list, and refines several product categories.

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

What Does a Clinical Trial Exemption Mean for IVD Registration in China?

A clinical trial exemption can provide significant advantages for manufacturers preparing an IVD registration application in China.

Potentially Faster Registration

For eligible products, exemption from a clinical trial can remove the need to conduct a China-specific clinical trial, potentially shortening the registration timeline by 6–12 months, depending on the product and overall evidence package.

Lower Clinical Development Costs

Avoiding a local clinical trial can reduce costs associated with study planning, site selection, patient recruitment, testing, data management, and clinical documentation.

Greater Flexibility for Short-Lifecycle Products

For IVDs with short product lifecycles or rapidly evolving technologies, a shorter regulatory pathway can improve the commercial value of entering the Chinese market sooner.

Clinical Trial Exemption Does Not Mean Clinical Evidence Exemption

One of the most important points for manufacturers is that exemption from a clinical trial is not exemption from clinical evidence requirements.

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

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.

Planning an IVD registration in China? Contact Cisema to assess your product’s clinical trial exemption eligibility, evaluate regulatory requirements, and develop a tailored China registration strategy.

Further Information

• Explore Cisema’s Clinical Development Services in China.
• Learn more about Cisema's services for IVD registration in China.
• Read our article about how China Medical Device Clinical Trial Strategy Affects NMPA Approval Timelines.

Reference

Read the original announcement about the 2025 Catalogue of In Vitro Diagnostic Reagents Exempt from Clinical Trials released by the NMPA.

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 and Refined Categories

The catalogue also refines five existing categories:

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".