NMPA published the “Clinical Trial Exempt Catalog for In Vitro Diagnostic Reagents (Draft)” on November 5, 2024, which newly-includes 387 IVDs. Feedback needs to be submitted by December 3, 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 Draft Catalog
- Herpes Simplex Virus Type I (HSV I) Antibody Test Kit
- Cytomegalovirus IgG Antibody Test Kit
- Toxoplasma IgG Antibody Test Kit
- Mumps Virus IgG Antibody Test Kit
- Adenovirus IgG Antibody Test Kit
- Varicella-Zoster Virus IgG Antibody Test Kit
- Phenobarbital Test Kit
- Methadone Test Kit
- Codeine Test Kit
- Cocaine Test Kit
- Morphine Test Kit
- Ketamine Test Kit
- Tetrahydrocannabinol Acid (THCA) Test Kit
- Benzodiazepine Test Kit
- Digoxin Test Kit
- Methamphetamine Test Kit
- Amphetamine Test Kit
- Methylenedioxymethamphetamine (MDMA) Test Kit
- Alpha-Fetoprotein (AFP) Test Kit
- Carcinoembryonic Antigen (CEA) Test Kit
- Total Prostate-Specific Antigen (tPSA) Test Kit
- Free Prostate-Specific Antigen (fPSA) Test Kit
- Complexed Prostate-Specific Antigen (cPSA) Test Kit
- Cytokeratin 19 Fragment (CYFRA21-1) Test Kit
- Squamous Cell Carcinoma Antigen (SCC) Test Kit
- Neuron-Specific Enolase (NSE) Test Kit
- Human Epididymis Protein 4 (HE4) Test Kit
- Cancer Antigen 125 Test Kit
- Cancer Antigen 15-3 Test Kit
- Carbohydrate Antigen 19-9 (CA19-9) Test Kit
- Carbohydrate Antigen 242 (CA242) Test Kit
- Carbohydrate Antigen 50 (CA50) Test Kit
- Cancer Antigen 72-4 Test Kit
- Tissue Polypeptide-Specific Antigen (TPS) Test Kit
- β2-Microglobulin Test Kit
- Ferritin Test Kit
- S100 Protein Test Kit
- Human Chorionic Gonadotropin (HCG) Test Kit
- β-Human Chorionic Gonadotropin (β-HCG) Test Kit
Class II IVDs in the Draft Catalog
The proposed products include but not limited to the following:
- Prostatic Alkaline Phosphatase (PAP) Test Reagent
- Prostatic Acid Phosphatase (PACP) Test Reagent
- Gastrin-Releasing Peptide Precursor (proGRP) Test Reagent
- Pepsinogen I Test Reagent
- Pepsinogen II Test Reagent
- κ Light Chain (Kappa Light Chain) Test Reagent
- λ Light Chain (Lambda Light Chain) Test Reagent
- α-L-Fucosidase Test Reagent
- Prolactin Test Reagent
- Calcitonin (CT) Test Reagent
- Hemoglobin Test Reagent
- Total Protein Test Reagent
- Albumin Test Reagent
- Prealbumin Test Reagent
- Glycated Hemoglobin Test Reagent
- Microalbumin Test Reagent
- Myoglobin Test Reagent
- Cardiac Troponin I Test Reagent
- Cardiac Troponin T Test Reagent
- Heart-type Fatty Acid Binding Protein Test Reagent
- N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Test Reagent
- B-type Natriuretic Peptide (BNP) Test Reagent
- Ischemia-modified Albumin Test Reagent
- C-Reactive Protein Test Reagent
- High-Sensitivity C-Reactive Protein Test Reagent
- Full Range C-Reactive Protein Test Reagent
- α1-Acid Glycoprotein Test Reagent
- Serum Amyloid A (SAA) Test Reagent
- Type III Collagen Test Reagent
- Type IV Collagen Test Reagent
- Laminin Test Reagent
- Unsaturated Iron-Binding Capacity Test Reagent
- Haptoglobin Test Reagent
- Total Protein in Cerebrospinal Fluid/Urine Test Reagent
- Retinol-Binding Protein Test Reagent
- Transferrin Test Reagent
- … …
For the entire English copy of the Clinical Trial Exempt Draft Catalog, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
For our service page on clinical evaluation exempt, please click HERE
