China Implements New IVD Classification Codes

Within the China NMPA is the medical device regulatory division called the Center for Medical Device Evaluation (CMDE). The CMDE covers both medical devices and IVDs. On May 10, 2024, the CMDE issued the Announcement of the IVD Classification Catalog. This new IVD classification catalog will become effective on January 1, 2025, and replace the previous IVD classification catalog. To help ensure a smooth transition to the new catalog, new IVD reagents will need to be categorized and filed in a specific format using 6840-XX as their primary code. For the primary code, IVD categories include reagents related to blood and tissue typing, reagents related to genetic diseases, reagents for companion diagnostics, etc. In addition, a secondary code XX-XXXX will also be needed as a sub-category under the primary code. IVD companies can access the specific categories via a drop-down menu in the eRPS system. For example, in the new IVD classification catalog, the classification code for the SARS-Covid nucleic acid detection reagents is 6840-01-01152.

The intended use of the IVD will be used to fill in the primary code. The secondary code can be chosen from appropriate sub-categories. If the appropriate classification codes cannot be found in the new IVD classification catalog, the applicant can use the code 6840-00-00000. If this is the case, the applicant may need to submit an IVD classification application to the National Institutes for Food and Drug Control (NIFDC). This application will require lots of detailed product information, and then it will take about 4 months to get the final classification ruling. However, if the expert committee and/or NIFDC cannot reach a classification determination, it is unclear how long the final classification will take.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)