NMPA's Center for Medical Device Evaluation Releases Revised Guidelines for Endotracheal Tube Products (2026 Edition)
The National Medical Products Administration (NMPA) Center for Medical Device Evaluation (CMDE) has announced the release of the revised Registration Review Guidelines for Endotracheal Tube Products (2026 Edition), effective January 9, 2026, as stated in Announcement No. 1 of 2026. The updated guidelines were developed to strengthen regulatory oversight and provide enhanced technical guidance for medical device registration applications and technical reviews.
The revised guidelines apply to Class II passive endotracheal tube products classified under code 08-06-03 in the Medical Device Classification Catalogue. The guidelines specifically exclude tracheostomy tubes and active endotracheal tubes with visualization components, though these products may reference applicable sections of the guideline. The comprehensive document addresses multiple critical aspects of endotracheal tube product registration, providing detailed requirements for manufacturers seeking regulatory approval.
The guidelines establish clear requirements for regulatory information documentation, including product nomenclature standards compliant with national naming regulations, registration unit classification principles, and documentation of prior communications with regulatory authorities. Technical documentation requirements cover working principles and structural composition, material specifications including silicone rubber and polyvinyl chloride, both cuffed and non-cuffed product configurations, and model and specification distinctions that manufacturers must clearly define in their submissions.
Non-clinical research requirements form a substantial portion of the guidelines, mandating risk management based on GB/T 42062 standards and performance indicators referencing YY/T 0337 standards. Biocompatibility evaluation must be conducted per GB/T 16886.1 and YY/T 1778.1 standards, while sterilization validation must achieve a sterility assurance level of 1×10⁻⁶. The guidelines also require comprehensive shelf-life and packaging research, along with lubricant compatibility studies to ensure product safety during clinical use.
Regarding clinical evaluation, the guidelines note that endotracheal tubes are listed in the Catalogue of Medical Devices Exempt from Clinical Evaluation. Applicants must demonstrate product equivalence according to established technical guidance but are not required to submit clinical evaluation data unless the product involves new materials, mechanisms, or functions. This exemption streamlines the approval process for conventional endotracheal tube products while maintaining rigorous safety standards.
Special emphasis is placed on labeling and instructions for use, requiring clear indication of patient populations such as adults and pediatrics, usage routes including oral and nasal insertion, and indwelling time specifications. Material allergy warnings must be prominently displayed, and for PVC products containing DEHP plasticizers, explicit labeling and toxicity warnings are mandatory. The guidelines also require lubricant compatibility information, including specific warnings against petroleum-based lubricants like liquid paraffin if studies indicate increased cuff leakage risk.
The guidelines highlight common adverse events associated with endotracheal tubes, including cuff air leakage, rupture, tube twisting, deformation, and fracture. Manufacturers are required to collect post-market surveillance data on similar products and incorporate this information into product design and risk management processes. This requirement ensures that real-world performance data continuously informs product safety improvements.
According to the CMDE, these guidelines serve as instructional documents for both registration applicants and technical reviewers. While not legally mandated, they should be followed in conjunction with applicable regulations and standards. Alternative approaches may be acceptable if supported by detailed research and validation data, allowing for innovation while maintaining safety standards. The guidelines will be updated periodically as regulations, standards, and scientific understanding evolve.
This revision reflects China's ongoing efforts to harmonize medical device regulatory standards with international best practices while ensuring patient safety and product efficacy. The detailed technical requirements and emphasis on risk management demonstrate the regulatory authority's commitment to quality oversight in the respiratory care device sector. For complete details, the full guideline document is available for download from the NMPA CMDE official website.