NMPA Priority Review – 3 Innovative IVD Products Selected

On August 24, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration published the "Public Notice of Review Results for Priority Approval Applications for Medical Devices (2026 No. 17)." In accordance with the "Procedures for Priority Approval of Medical Devices," the Priority Review Office has identified projects that meet the criteria for priority review and is now conducting a public disclosure period from August 24 to August 31, 2026.

Three projects have been selected for the priority review pathway in this batch:

Project 1 – "Unconjugated Bilirubin Assay Kit (LC-MS/MS)" (Acceptance No. CSZ2600245), filed by Shenzhen Huiyun Biotechnology Co., Ltd. This product qualifies as a "medical device for diagnosing or treating rare diseases with significant clinical advantages".

Project 2 – "Claudin18.2 (EPR19202) Antibody Reagent (Immunohistochemistry)" (Acceptance No. CSZ2600259), filed by Guangzhou Anbiping Medical Technology Co., Ltd. This product qualifies as "clinically urgent with no equivalent product yet approved in China".

Project 3 – "Leber Hereditary Optic Neuropathy Gene Detection Kit (PCR-Fluorescence Probe Method)" (Acceptance No. CSZ2600262), filed by Wenzhou Puxi Gene Technology Co., Ltd. This product meets two priority review criteria simultaneously: "diagnosing rare diseases with significant clinical advantages" AND "clinically urgent with no equivalent product yet approved in China".

During the public disclosure period, any individual or organization with objections may complete the Priority Review Project Objection Form and submit it to the Center's email: gcdivision@cmde.org.cn.