NMPA CMDE Releases Guidance on Registration Review of Batteries for Active Implantable Medical Devices (2026 No. 27)

On October 8, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration officially released the Guidance on Registration Review of Batteries for Active Implantable Medical Devices (Announcement No. 27 of 2026), aimed at standardizing the registration application and technical review of batteries used in active implantable medical devices. The announcement states that the guidance was developed to standardize the management of active implantable medical devices and takes effect upon publication.

Scope of Application

This guidance applies to batteries used in active implantable medical devices, covering chemical batteries such as lithium-ion, nickel-metal hydride, nickel-cadmium, lead-acid, and dry batteries; physical batteries such as photovoltaic cells; and new-type batteries such as flexible batteries. It also serves as a useful reference for batteries used in other medical devices. It does not apply to nuclear batteries and biofuel cells.

Battery Classification and Core Technical Requirements

The guidance establishes two classification dimensions: by technical principle and implementation scheme, batteries are categorized into cells and battery packs (with protection circuits or battery management systems); by reusability, they are categorized into primary batteries and secondary batteries. In terms of non-clinical research, the guidance emphasizes key verification items including battery discharge characteristics testing, life cycle testing, protection circuit requirements, and qualification testing of cells and battery packs. Additionally, applicants must provide research data on battery combustion and explosion risks, demonstrating that such risks are acceptable under normal conditions and single-fault conditions.

Risk Management and Lifecycle Considerations

The guidance requires applicants to systematically identify battery-related hazards, including leakage, overheating, fire, explosion, and shelf-life failure, and to conduct risk analysis with reference to the GB 16174 series of mandatory standards. Particular attention should be paid to risks arising from the intended use environment and conditions (such as temperature, humidity, pressure, and vibration).

Instructions and Labeling Requirements

Applicants must specify in the instructions how to indicate battery status (e.g., continuous indication or operator-initiated indication), indicate the charging status or estimated charge level for rechargeable batteries, and clarify information such as the battery's expected service life.

This guidance provides a unified technical review standard for the registration of batteries used in active implantable medical devices and holds significant reference value for AIMD registration holders.