NMPA Center for Medical Device Evaluation Seeks Public Comments on 6 Draft Registration Review Guidelines

On September 4, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration issued a notice seeking public comments on 6 draft Medical Device Registration Review Guidelines.

The 6 draft guidelines cover multiple high-risk medical device categories including radiotherapy equipment, infusion devices, cardiovascular implants, and hemodynamic monitoring products. The key contents of each guideline are as follows:

1. Gamma-Ray Stereotactic Radiotherapy System Registration Review Guideline (Draft for Comments)

This guideline applies to gamma-ray stereotactic radiotherapy systems with classification code 05-01-04 under the Medical Device Classification Catalog, mainly including systems for cranial, body, and whole-body gamma-ray stereotactic radiotherapy. The guideline provides systematic registration review requirements covering regulatory information, summary information, non-clinical data, clinical evaluation, and product labeling, with detailed specifications for components including gantry/radiation units, patient support devices, stereotactic localization devices, electrical control systems, image guidance devices (if applicable), optical positioning/setup/tracking devices (if applicable), control system software, radiotherapy treatment planning software (if applicable), and radiotherapy record and verification software (if applicable).

2. Medical Electron Linear Accelerator Registration Review Guideline (Draft for Comments)

This guideline applies to medical electron linear accelerators with classification code 05-01-01 under the Medical Device Classification Catalog. Other similar products such as helical tomotherapy systems (TOMO), X-ray stereotactic radiotherapy systems, or products adopting new technologies such as ultra-high dose rate accelerators may refer to this guideline. The guideline specifies registration requirements for components including radiation generation systems, radiation modulation systems, dose monitoring systems, gantries, patient support devices, electronic portal imaging devices, image guidance devices, and workstations, with clear requirements for technical features including 3D conformal radiotherapy, intensity-modulated radiotherapy (static/dynamic), volumetric modulated arc therapy (VMAT), image-guided radiotherapy (offline/online/real-time), motion management, flattening filter-free (FFF) mode, stereotactic radiotherapy (SRT), stereotactic radiosurgery (SRS), and adaptive radiotherapy (offline/online/real-time).

3. Electronic Infusion Pump Registration Review Guideline (Draft for Comments)

This guideline applies to electronic infusion pumps used clinically for analgesia and chemotherapy, with Class III management category and classification code 14-02-01. Products dedicated to analgesia may be named "electronic analgesia pump," and products dedicated to chemotherapy may be named "electronic chemotherapy pump." The guideline provides systematic registration review requirements covering regulatory information, summary information, non-clinical data, clinical evaluation, and product labeling, including descriptions of drive devices, reservoir devices, and infusion line structures and performance, product risk management, product technical requirements, software research, biological evaluation, cleaning/disinfection/sterilization studies, and stability studies. The product scope of application is: used in medical institutions for intravenous and epidural infusion of analgesic drugs, and intravenous infusion of chemotherapeutic drugs.

4. Implantable Cardiac Pacemaker Registration Review Guideline (2026 Revision) (Draft for Comments)

This guideline applies to implantable cardiac pacemakers, including implantable cardiac resynchronization therapy pacemakers, with Class III management category and classification code 12-01-01. Single-chamber and dual-chamber pacemakers are named "implantable cardiac pacemakers," three-chamber pacemakers are named "implantable cardiac resynchronization therapy pacemakers," and leadless pacemakers are named "implantable leadless cardiac pacemakers." The guideline provides systematic registration review requirements covering regulatory information, summary information, non-clinical data, clinical evaluation, and product labeling, including product structure descriptions, pacing modes and electrical performance parameters, automated functions (such as rate-adaptive pacing, automatic threshold management, automatic mode switching, remote monitoring, etc.), product risk management, product technical requirements, software research, biological evaluation, sterilization studies, animal studies, usability studies, and stability studies.

5. Implantable Cardiac Pacing Lead Registration Review Guideline (2026 Revision) (Draft for Comments)

This guideline applies to implantable cardiac pacing leads, with Class III management category and classification code 12-01-04. The guideline does not cover defibrillation leads or epicardial leads. The product name is generally standardized as "implantable cardiac pacing lead," and leads applicable to the left ventricle are standardized as "implantable left ventricular pacing lead." The guideline provides systematic registration review requirements covering regulatory information, summary information, non-clinical data, clinical evaluation, and product labeling, including working principles and structural composition of pacing leads, physical and mechanical performance studies, biocompatibility evaluation, sterilization studies, animal studies, usability studies, stability studies, MRI safety studies, and drug-eluting device studies (if applicable).

6. Hemodynamic Monitoring Product Registration Review Guideline (Draft for Comments)

This guideline applies to medical devices intended for monitoring hemodynamic parameters, such as floating catheters, volume and pressure measurement sensors, cardiac output and pressure measurement sensors, finger cuff sensors, hemodynamic measurement devices (including cardiac output monitors), hemodynamic monitors, hemodynamic calculation products, and hemodynamic function modules of hemodynamic and electrophysiological recording systems. The management category is Class III, with classification code 07-10-00 for application parts and accessories, and 07-03-00 or 07-04-00 for devices. The guideline provides systematic registration review requirements covering regulatory information, summary information, non-clinical data, clinical evaluation, and product labeling, including technical requirements for invasive, minimally invasive, and non-invasive hemodynamic parameter monitoring products, risk management, software research, biological evaluation, sterilization studies, animal studies, usability studies, and stability studies.

Submission Deadline & Method

Please submit your feedback and suggestions via the official feedback form by email no later than October 8, 2026. Please format the email subject and filename as: "Feedback on [Guideline Name] (Draft for Comments) + [Your Organization Name]".