Public Comment Alert | China NMPA CMDE releases the draft of the 2026 revised Guidance for Registration Review of Active Medical Device Service Life

On September 14, 2026, the Center for Medical Device Evaluation of China’s National Medical Products Administration issued a public consultation on the “Guidance for Registration Review of Active Medical Device Service Life (2026 Revision) (Draft for Comments).” The comment period runs until October 9, 2026. Relevant units may submit opinions and suggestions according to the notice requirements.

The consultation package includes Attachment 1, the draft guidance, and Attachment 2, the comment feedback form. Attachment 1 applies to active medical devices, excluding stand-alone medical device software. It defines the service life of an active medical device as the expected period of safe and effective use determined by the applicant through risk management before market launch. The service life runs from the finished device to the end of its service life, covering both the period before use and the period after use. It may be expressed in time or in use cycles, such as CT tube exposure counts. In addition to active medical devices provided sterile, sterile components contained in active medical devices need a separate shelf life. For products or parts that can be repeatedly sterilized, the tolerable number of sterilization cycles should also be specified.

The draft emphasizes full lifecycle risk management. Service life is not a fixed absolute value, but the result of reliability-related risk management implemented by the applicant across the total lifecycle. If, within the service life determined before market launch, safety or effectiveness degrades to an unacceptable risk level, the applicant should immediately assess the risk, take corresponding risk control measures, re-evaluate the service life, and submit relevant study materials in accordance with regulatory requirements. For active medical devices used to treat life-threatening diseases where performance degradation is poorly tolerated, such as implantable cardiac pacemakers, the draft requires high reliability through design and verification, ensuring that aging-related failure risk remains at an acceptable extremely low level within the service life. It is recommended that applicants study the service life based on reliability indicators.

Applicants may determine service life in two general ways: pre-setting a service life and verifying its reasonableness through one or more methods, or not pre-setting a value and ultimately determining the service life through one or more methods. Evaluation can be performed at the whole-device level or by decomposing the device into different subsystems or parts. Path 1 directly verifies the service life of the whole device, for example through real-time aging or accelerated aging tests, while also considering key components. Path 2 decomposes the device into different categories, such as key and non-key parts, replaceable and non-replaceable parts, moving and non-moving parts, and electronic and mechanical parts, and then comprehensively determines the service life. The sum of the service lives of subsystems or parts does not equal the service life of the whole device. Applicants need to consider coupling effects and the logical relationship between subsystems or parts and the whole device, and further conduct a comprehensive evaluation at the whole-device level to demonstrate that long-term interactions and system-level failure modes under clinical use conditions will not lead to unacceptable risks within the service life.

Factors to consider include key components, frequency and intensity of use, transport, storage and use environment, cleaning and disinfection, packaging and sterilization, repair, maintenance and servicing, and commercial factors. Evaluation methods include accelerated aging tests, real-time aging data, empirical data, reliability prediction, simulation and other theoretical calculations. The draft encourages test verification first when conditions permit, and allows methods to be used alone or in combination. It also sets principles for component evaluation, similar product or part comparison, and empirical data selection, requiring empirical data to be truthful, sufficient, unbiased, and traceable, with distribution information and confidence intervals provided.

For registration, applicants should consider aging-related risks in the risk analysis materials and submit service-life-related study materials in CH3.7. The instructions and labels should clearly state the product service life. If the product contains replaceable key components, both the whole-device service life and the component service life should be specified. If the service life is related to repair, maintenance and servicing, relevant information such as replacement methods and periodic replacement cycles should be specified. For change registration, applicants need to analyze the impact of the change on service life; if there is an impact, relevant service-life study materials should be submitted. For renewal registration, if the service life is not changed, service-life-related study materials are not required.

Attachment 1 also includes Appendix I on accelerated testing methods, covering acceleration models, acceleration factors, sample size, confidence level, Weibull distribution, and more. It notes that for active implantable medical devices, accelerated testing generally needs statistical significance for a general failure rate below 0.5% per year. Appendix II provides a service-life analysis and evaluation report template, with an example for an X-ray computed tomography (CT) device. The example covers purpose, evaluation approach, evaluation path, influencing factor analysis, evaluation method summary, conclusion, and attachments, which may include accelerated aging test reports, fatigue test reports, simulation calculation reports, reliability analysis reports, empirical data comparison reports, and risk analysis reports.