NMPA published the “Clinical Trial Exempt Catalog for In Vitro Diagnostic Reagents” on June 24, 2025, which exempts 445 IVDs from clinical trials, including 27 Class III IVDs. The draft was published in November 2024. Implementing risk-based clinical evaluation, the catalog is intended to make clinical exemptions more consistent with internationally accepted standards.
Ask us if your IVDs are in the catalog. Even if not, we can develop clinical evaluation strategies to help you avoid the expensive and time-consuming clinical trial. info@ChinaMedDevice.com.
How Exempt Catalog Works
1) the corresponding content in the catalog.
2) the predicate already approved in China.
The items to be compared include but not limited to the working principle, components, material, performance requirements, sterile/disinfection method, application scope, methods about how to use the device. Based on the comparison, if there is any difference between the predicate and the product to be registered, the applicant needs to justify that the difference will not lead to new risk(s) in terms of product safety and effectiveness.
The submitted comparison document needs to be able to prove that the product to be registered is essentially the same as the product in the “Clinical Exempt Catalog”, otherwise, the applicant needs to identify and collect the clinical evidence and submit the CER together with the clinical evidence the CER is based on.
The following principles are required for a device/IVD to be on the exempt catalog：
• The working mechanism is clear.
• The design and production process are mature.
• Similar types of medical devices have been marketed and used in clinical settings for many years.
• There is no record of serious adverse events.
• The medical device is safe and effective through evidence of nonclinical evaluation.
• The analysis and evaluation of data obtained from clinical trials, or clinical use of the similar types, can demonstrate safety and efficacy.
Class III IVDs in the Catalog
The catalog includes the following Class III IVDs. Worth noting that the products that are intended for patient self-testing or neonatal testing are not within the scope of exemption from clinical trials.
- Herpes Simplex Virus Type I (HSV I) IgG Antibody Test Kit
- Herpes Simplex Virus Type II (HSV II) IgG Antibody Test Kit
- Rubella Virus IgG Antibody Test Kit
- Toxoplasma IgG Antibody Test Kit
- Cytomegalovirus (CMV) IgG Antibody Test Kit
- Mumps Virus IgG Antibody Test Kit
- Varicella-Zoster Virus (VZV) IgG Antibody Test Kit
- Adenovirus IgG Antibody Test Kit
- Amphetamine Test Kit
- Methamphetamine Test Kit
- 3,4-Methylenedioxy-N-methylamphetamine (MDMA) Test Kit
- Phenobarbital Test Kit
- Benzodiazepines Test Kit
- Ketamine Test Kit
- Tetrahydrocannabinolic Acid (THCA) Test Kit
- Codeine Test Kit
- Cocaine Test Kit
- Morphine Test Kit
- Methadone Test Kit
- Digoxin Test Kit
- Human Chorionic Gonadotropin (HCG) Test Kit
- β-Human Chorionic Gonadotropin (β-HCG) Test Kit
- Golgi Protein 73 (GP73) Test Kit
- Alpha-Fetoprotein (AFP) Test Kit
- Free Prostate-Specific Antigen (fPSA) Test Kit
- Complexed Prostate-Specific Antigen (cPSA) Test Kit
- Total Prostate-Specific Antigen (tPSA) Test Kit
Class II IVDs in the Catalog
The catalog includes but not limited to the following:
- Type III Collagen Test Kit
- N-terminal Propeptide of Type III Procollagen (PⅢ-NP) Test Kit
- Type IV Collagen Test Kit
- C-Reactive Protein (CRP) Test Kit
- High-Sensitivity C-Reactive Protein (hs-CRP) Test Kit
- Full-Range C-Reactive Protein Test Kit
- Total Procollagen Type I N-Terminal Propeptide (Total-P1NP) Test Kit
- S100-β Protein Test Kit
- S100 Protein Test Kit
- α1-Acid Glycoprotein Test Kit
- α1-Microglobulin Test Kit
- α2-Macroglobulin Test Kit
- β2-Microglobulin Test Kit
- β-CrossLaps (β-CTX) Test Kit
- Kappa Light Chain Test Kit
- Lambda Light Chain Test Kit
- Free Kappa Light Chain Test Kit
- Free Lambda Light Chain Test Kit
- Cancer Antigen 125 (CA125) Test Kit
- Cancer Antigen 15-3 (CA15-3) Test Kit
- Cancer Antigen 72-4 (CA72-4) Test Kit
- Carcinoembryonic Antigen (CEA) Test Kit
- Laminin Test Kit
- Trefoil Factor Test Kit
- Calprotectin Test Kit
- Heparin-Binding Protein (HBP) Test Kit
- High-Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit
- High-Sensitivity Cardiac Troponin T (hs-cTnT) Test Kit
- Cardiac Troponin I (cTnI) Test Kit
- Cardiac Troponin T (cTnT) Test Kit
- Osteocalcin Test Kit
- Cystatin C Test Kit
- Myoglobin Test Kit
- … …
For the entire English copy of the Clinical Trial Exempt Catalog, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
For our service page on clinical evaluation exempt, please click HERE
