China Issues Battery Registration Guidance for Active Implantable Medical Devices

On October 8, 2026, China’s Center for Medical Device Evaluation (CMDE) issued the Guiding Principles for Registration Review of Batteries for Active Implantable Medical Devices under Announcement No. 27 of 2026.

The guidance clarifies expectations for battery-related documentation in registration applications, covering product descriptions, risk management, nonclinical evidence, safety and performance, and labeling.

Scope Covers Chemical, Physical and Emerging Battery Technologies

The guidance applies to batteries used in active implantable medical devices, including products such as cardiac pacemakers, cochlear implants and implantable neurostimulators, and establishes a general review framework that may be supplemented by device-specific requirements where necessary.

Covered technologies include:

• Chemical batteries, including lithium-ion, nickel-metal hydride, nickel-cadmium, lead-acid and dry-cell batteries
• Physical batteries, such as photovoltaic cells
• Emerging technologies, including flexible batteries

Nuclear batteries and biofuel cells are excluded.

Registration Dossiers Must Address Battery Design and Performance

Applicants must provide battery-related information across the relevant sections of the registration dossier, covering:

• Battery cell and battery-pack specifications
• The proposed device's marketing history
• Battery-related risk management documentation
• Nonclinical testing and supporting evidence
• Applicable safety and performance requirements
• Relevant information in the instructions for use and labeling

Manufacturers remain responsible for the completeness and consistency of the submission, even when batteries are sourced from third-party suppliers. They must therefore ensure that suppliers can provide the technical documentation needed to support the finished-device application and ensure that battery information aligns across the product overview, risk management file, nonclinical documentation, instructions for use, and labeling. Gaps in supplier evidence or inconsistencies between dossier sections could prompt questions during CMDE review.

Risk Management Must Cover the Battery Lifecycle

Applicants must identify hazards associated with the battery throughout its lifecycle. Risk analysis should consider the battery cell’s chemical or physical characteristics, battery-pack design and how the battery interacts with the implantable device.

Manufacturers must demonstrate that identified risks have been reduced to an acceptable level and provide evidence verifying the effectiveness of the corresponding controls.

The assessment should also address the environments in which the device is expected to be transported, stored, and used. Relevant conditions may include:

• Temperature and humidity
• Altitude and atmospheric pressure
• Vibration
• Electromagnetic environments
• Radiation environments

Where evidence is insufficient, additional testing or a documented technical justification may be necessary.

What the Guidance Means for Foreign Manufacturers

Foreign manufacturers may need to coordinate more closely with battery suppliers to obtain complete information about cell characteristics, battery-pack design, manufacturing controls, and testing.

They should also ensure that battery information remains consistent across the product overview, risk management file, nonclinical documentation, instructions for use, and labeling. Inconsistencies between these sections could lead to questions during the CMDE review.

Recommended Next Steps

Manufacturers should assess existing battery documentation against the final guidance before submitting or updating an NMPA application.

Key priorities include: 

1. Confirm Applicable Requirements: Verify that the battery falls within the guidance’s scope and identify any device-specific requirements.
2. Address Documentation Gaps: Ensure the dossier covers battery cell and pack specifications, manufacturing controls, and relevant technical information from third-party suppliers.
3. Update Risk Assessments: Cover battery-specific hazards throughout the lifecycle, including integration with the implantable device, transportation, storage, and use. Confirm that risk controls are supported by evidence.
4. Verify Test Coverage: Check that existing reports reflect the device’s intended operating and environmental conditions. Determine whether additional testing or technical justification is needed.
5. Check Dossier Consistency: Reconcile battery information across the product overview, risk management file, nonclinical documentation, instructions for use, and labeling.

Applications based on the draft principles published for consultation in December 2022 warrant particular attention. Manufacturers should check existing documentation against the final guidance to identify gaps and address potential review questions before submission.

Final Thoughts

The new guidance gives manufacturers a clearer framework for addressing battery-related requirements in active implantable medical device registrations. The challenge lies in translating these requirements into a complete, well-coordinated submission, particularly when critical technical information must be obtained from third-party battery suppliers.

To navigate these requirements efficiently, manufacturers need a clear understanding of the evidence required and how it fits into the broader registration dossier. Cisema supports this process by identifying documentation gaps, coordinating with suppliers, and preparing registration materials aligned with China’s regulatory expectations, helping manufacturers address potential issues before submission.

For expert support with your China medical device registration strategy and NMPA application, contact Cisema today.

Further Information

• Explore Cisema’s China medical device registration services.
• Read about the CMDE’s 2026–2027 medical device registration guideline roadmap.

References

• Center for Medical Device Evaluation, Guiding Principles for Registration Review of Batteries for Active Implantable Medical Devices, Announcement No. 27 of 2026. 国家药监局器审中心关于发布有源植入式医疗器械电池注册审查指导原则的通告（2026年第27号）