NMPA Releases 11 Draft Technical Review Guidelines for Medical Devices, Covering Cardiovascular, Radiotherapy, Orthopedics, IVD, and Oncology Treatment

On October 8, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration issued a notice soliciting public comments on 11 draft technical review guidelines, including the "Technical Review Guideline for Cardiac Rhythm Management Device Programmers (Draft for Comments)." The comment period closes on November 9, 2026.

The 11 draft guidelines cover a wide range of medical device fields, including cardiac rhythm management device programmers, radiotherapy surface optical positioning/setup tracking systems, infusion information collection systems, 3D-printed calcium phosphate bone filling materials, silk fibroin bone internal fixation implants, arteriovenous cannulae, infusion connectors, Pneumocystis jirovecii nucleic acid detection reagents, SLCO1B1 gene polymorphism detection reagents, HER2 antibody reagents and detection kits (immunohistochemistry method), and clinical trial technical review guidelines for tumor electric field therapy devices in treating rare diseases.

Among these, the guideline for tumor electric field therapy devices specifies that such products must undergo clinical trial data evaluation to demonstrate safety and efficacy in treating patients with newly diagnosed and/or recurrent glioblastoma. Glioblastoma has been included in the second batch of the rare disease catalogue published by the National Health Commission, meeting the applicable conditions for conditional approval pathways. The guideline also sets forth systematic requirements for clinical trial design, study population, evaluation endpoints, sample size, and post-market studies.

The HER2 antibody reagent guideline focuses on antibody reagents for detecting HER2 antigen in pathological tissue sections using immunohistochemistry, which are clinically used as companion diagnostics for HER2-targeted therapies in breast cancer and other tumors. The guideline provides detailed specifications for analytical performance studies, positive cut-off value studies, and key raw material research.

The SLCO1B1 gene polymorphism detection reagent guideline applies to reagents using fluorescence PCR for in vitro qualitative detection of SLCO1B1 gene polymorphisms in DNA from patients' venous whole blood or oral swab samples, used for guiding individualized statin medication. The Pneumocystis jirovecii nucleic acid detection reagent guideline addresses reagents using real-time fluorescence PCR for in vitro qualitative diagnosis of Pneumocystis jirovecii nucleic acid in bronchoalveolar lavage fluid and sputum samples, used for auxiliary diagnosis of Pneumocystis jirovecii infection.

In the field of orthopedic implants, the 3D-printed calcium phosphate bone filling material guideline applies to porous calcium phosphate implants produced through additive manufacturing processes, while the silk fibroin bone internal fixation implant guideline applies to orthopedic internal fixation implants made from silk fibroin fiber materials. Additionally, the arteriovenous cannula and infusion connector guidelines set forth specific requirements for the registration applications of disposable arteriovenous cannulae and disposable infusion connectors, respectively.

The cardiac rhythm management device programmer guideline applies to specialized systems used for reading, querying, data display, parameter programming, and performance testing of implantable medical devices and electrode leads, covering review focus areas such as summary documentation, non-clinical data, and product instructions and labels. The radiotherapy surface optical positioning/setup tracking system guideline applies to systems used for optical surface positioning in CT simulation rooms or optical surface setup verification, tracking, and monitoring in treatment rooms during radiotherapy.

Those with comments or suggestions are requested to fill out the feedback form and submit it via email to the corresponding CMDE contact person by November 9, 2026. The email subject and file name should follow the format: "Feedback on [XX Draft Technical Review Guideline] + Name of Feedback Organization".