The NMPA Medical Device Standardization Administration issued the “Third Batch of Medical Device Classification Results for 2024” on November 20, 2024. The document identifies 268 IVD reagents. It is the summary of classification requests submitted by overseas and domestic manufacturers.
It also lists the contact numbers for each NMPA review department. If you want a face-to-face consultation, just as FDA’s pre-sub, with NMPA reviewers, please email us at info@ChinaMedDevice.com.
Classification Procedures
The NMPA regulatory process is kicked off by classifying your device. First, you need to go through the China medical device classification catalog, effective since August 1, 2018. You can find the category, subcategory, example of device names, product description and intended use for your device. If not clear, you can look up on the classification results, released two or three times each year, for reference. When you cannot figure out the device classification in the catalogue and results, you will need to file for classification request.
The List
The IVD reagents identified by the Classification Results include but not be limited to the following. It also briefly describes each device with classification code.
Class III
- Human Plasma Free DNA Detection Kit
- ROS1 Antibody Reagent
- BCOR Antibody Reagent
- IGH/MAF Fusion Gene Detection Kit
- IGH Gene Break-Apart Recombination Detection Kit
- CHOP Gene Break-Apart Recombination Detection Kit
- IGH/FGFR3 Fusion Gene Detection Kit
- ETV6/MET Fusion Gene Probe Reagent
- FN1/FGFR1 Fusion Gene Probe Reagent
- YAP1/TFE3 Fusion Gene Probe Reagent
- SFPQ/TFE3 Fusion Gene Probe Reagent
- EWSR1/CREB3L1 Fusion Gene Probe Reagent
- EWSR1/CREM Fusion Gene Probe Reagent
- DEK/NUP214 Fusion Gene Probe Reagent
- MEF2C/SS18 Fusion Gene Probe Reagent
- EWSR1/DUX4 Fusion Gene Probe Reagent
- EWSR1/SMAD3 Fusion Gene Probe Reagent
- EWSR1/PATZ1 Fusion Gene Probe Reagent
- FN1/EGF Fusion Gene Probe Reagent
- C-MYC Gene Break-Apart Detection Kit
- YAP1 Gene Break-Apart Probe Reagent
- FN1 Gene Break-Apart Probe Reagent
- CCDC6 Gene Break-Apart Probe Reagent
- PRKD1 Gene Break-Apart Probe Reagent
- GREB1 Gene Break-Apart Probe Reagent
- PRCC Gene Break-Apart Probe Reagent
- RAF1 Gene Break-Apart Probe Reagent
- QKI Gene Break-Apart Probe Reagent
- MAML3 Gene Break-Apart Probe Reagent
- PATZ1 Gene Break-Apart Probe Reagent
- … …
Class II
- Trypsin-like Enzyme Detection Kit
- Deamidated Gliadin Peptide Antibody IgA Detection Kit
- Deamidated Gliadin Peptide Antibody IgG Detection Kit
- RANKL Detection Kit
- PAC-1 Detection Kit
- TEX101 Detection Kit
- IP-10 Detection Kit
- IL-2RA/IL-18/IL-33/IL-23/IL-27/IL-22 Detection Kit
- OPG Detection Kit
- Anti-GABABR1 Antibody IgG Detection Kit
- Anti-NF155 Antibody IgG4 Detection Kit
- Anti-LGI1 Antibody IgG Detection Kit
- Dabigatran Detection Kit
- Amikacin Detection Kit
- THSD7A Antibody IgG Detection Kit
- MDA Detection Kit
- CC16 Detection Kit
- MCR-1 Enzyme Detection Kit
- 14 Cytokine Detection Kit
- Anti-GABABR Antibody Detection Kit
- HFREP1 Protein Detection Kit
- SP-D Detection Kit
- SP-A Detection Kit
- Vaginal Secretion pH Detection Kit
- DAZL Protein Detection Kit
- … …
