NMPA Collects Public Comments On Guidelines For Registration Review Of Implantable Medical Device Battery

In order to standardize the requirements for technical review and guide the registration and application of enterprises, CMDE has organized the drafting of the Guidelines for Registration Review of Implantable Medical Device Battery (Draft for Comments), which will solicit comments from now on.

Scope Of Application

These guidelines apply to implantable medical device batteries, for other medical device batteries also have some reference significance, including but not limited to lithium-ion batteries, nickel-metal hydride batteries, nickel-cadmium batteries, lead batteries, dry cells and other chemical batteries, photovoltaic batteries and other physical batteries, flexible batteries and other new batteries.

For the general requirements of implantable medical device products, applicants should refer to the active implantable medical device products technical review guidelines, such as the Guidelines for Technical Review of Implantable Left Ventricular Assist System Registration, the Guidelines for Technical Review of Implantable Pacemaker Registration, and the Guidelines for Technical Review of Cochlear Implant System Registration, etc.

These guidelines do not apply to physical cells such as nuclear cells and biofuel cells.

Registration Review Highlights

In accordance with the NMPA Notice No. 121 of 2021 Annex 5, the applicant should be in the regulatory information, review data, non-clinical data, product IFU and labeling samples and other chapters (including secondary title content), respectively clarifying the content of the relevant registration declaration of the battery, if necessary, should be accompanied by relevant technical information.

Reference to the Basic Principles for the Safety and Performance of Medical Devices, the applicant should specify the basic design and production requirements, and shall be able to design and produce batteries that meet the expected safety and performance requirements throughout the life cycle of medical devices.

It is a great opportunity to have your voices heard by NMPA reviewers and influence them to form a more practical Guideline in the end. If you have any comments on the Registration Review of Implantable Medical Device Battery, please send us your feedback to info@bradyknowsmedical.com before January 6, 2023.