China NMPA Releases 2025 Catalog of In Vitro Diagnostic Reagents Exempt from Clinical Trials
On June 24, 2025, China’s National Medical Products Administration (NMPA) issued an updated catalog of in vitro diagnostic (IVD) reagents that are exempt from clinical trial requirements. The “Catalog of In Vitro Diagnostic Reagents Exempt from Clinical Trials (2025),” published under Announcement No. 23 of 2025, takes immediate effect from the date of release.
This update was formulated in accordance with the "Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents" (Order No. 48 of the State Administration for Market Regulation). The new catalog revises and replaces the previous version released in NMPA Announcement No. 70 of 2021.
Key Highlights:
- Scope: The catalog details hundreds of IVD reagents by product category, name, intended use, and regulatory classification. Notably, reagents for patient self-testing and newborn screening are excluded from exemption.
- Examples of Exempt Products:
- Pathogen diagnostic kits such as Herpes Simplex Virus (HSV) IgG antibody test reagents.
- Tumor markers like Human Chorionic Gonadotropin (HCG) and prostate-specific antigen (PSA) reagents.
- Drugs of abuse test kits for substances including morphine, cocaine, and methadone.
- Biochemical markers, vitamin assays, and autoimmune antibodies.
- Regulatory Category: The catalog specifies the management class (e.g., Class II, Class III) of each listed assay.
Regulatory Impact:
The release of the exempt products catalog streamlines the registration process for IVD manufacturers, both domestic and international, entering the Chinese market. Products included in the list can apply for NMPA registration without conducting local clinical trials, provided all other regulatory requirements are fulfilled.
The NMPA emphasizes that companies should refer to the detailed catalog to confirm exemption eligibility. Products with intended uses related to patient self-testing or neonatal screening are not covered by this exemption.