NMPA Center for Medical Device Evaluation Releases "Guidance for Registration Review of Central Venous Catheters (2026 Revision)"

On July 15, 2026, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) officially released the "Guidance for Registration Review of Central Venous Catheters (2026 Revision)".

To further standardize the registration application and technical review of related products, the CMDE has completed this revision. The guidance is intended to assist applicants in the preparation and drafting of registration application dossiers for central venous catheter products, and also serves as a technical reference for the technical review department.

The guidance clarifies the scope of application: it applies to central venous catheters with classification code 03-13-03, including central venous catheters (CVC) inserted via the internal jugular vein, subclavian vein, and femoral vein, as well as peripherally inserted central catheters (PICC). It does not apply to central venous catheters with implantable infusion ports.

In terms of registration review highlights, the guidance covers regulatory information, general information, non-clinical information (risk management, product performance studies, biological evaluation, sterilization process studies, stability studies, etc.), clinical evaluation data, product instructions and labeling samples, and quality management system documentation. The product performance studies section includes an appendix table listing 32 recommended performance study items, including dimensions, peak pull force, flow rate, leakage, particulate contamination, chemical properties, sterility, bacterial endotoxins, etc., with clear indications of whether each item is recommended for inclusion in the product technical requirements.

This guidance is a reference document for applicants and technical reviewers, and should be used in compliance with relevant regulations and mandatory standards. Alternative methods that meet regulatory requirements may also be adopted, provided that detailed research and validation data are submitted.