Register for Upcoming Webinar on DEC. 8 @ 11AM
2025 China NMPA Bluebook is here:
NMPA released the “Clinical Evaluation Guideline for In Vitro Diagnostic Reagents for Cancer Screening” on August 21, 2025. The document provides direction for applicants preparing registration dossiers and clinical evaluation
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
NMPA published the “Clinical Evaluation Exempt Catalog for Medical Devices” on May 13, 2025, which newly-includes 27 medical devices, including 7 Class III and 20 Class II devices. Implementing risk-based
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.
NMPA published the “Clinical Evaluation Exempt Catalog for Medical Devices (Draft)” on July 31, 2024, which newly-includes 23 medical devices. Feedback needs to be submitted by August 30, 2024. Implementing
NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” today on March 18, 2024. The document suggests manufacturers how to choose predicate device comparison or clinical trial
The NMPA published the final version of “Clinical Evaluation Exempt Catalog for Medical Devices” on July 20, 2023, which includes 2025 medical devices. Implementing risk-based clinical evaluation, the catalog will
NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on June 16, 2022. The document suggests manufacturers how to choose clinical evaluation exemption, predicate device comparison or
The NMPA released the “Catalog of Medical Devices and IVD Products Exempted from Clinical Trials” on September 18, 2021, which includes 1010 devices and 423 IVDs. It is an effort
The NMPA issued eight draft guidelines to regulate the clinical pathways in May. Feedback needs to be submitted to the NMPA by May 30, 2021. Complete List Medical Device Clinical
The NMPA released the Revised Catalog of Medical Devices and IVD Products Exempted from Clinical Trials on January 19, 2021. It is an effort to implement risk-based clinical evaluations, and