China’s NMPA Revamps Medical Device Classification Rules to Improve Regulatory Efficiency

The National Medical Products Administration (NMPA) has revised the “Notice on Standardizing the Classification of Medical Device Products,” initially issued by the China Food and Drug Administration in 2017. The updated document, which will be effective from September 1, 2024, aims to enhance the classification management of medical devices, standardize the classification and definition of these products, and streamline related work procedures.

The updated notice is divided into three sections: classification and definition work, product classification-related situations, and other matters, comprising a total of 16 articles. The key adjustments from the previous version include:

1. It further clarifies the roles and responsibilities of classification and definition work, mandating that drug regulatory authorities provide classification and definition services to medical device registrants and applicants.
2. It refines the application channels and processes for classification and definition, optimizing workflow and timeline requirements. Applications for newly developed devices should be reported to the NMPA’s device standards management center. For devices with uncertain management categories, existing procedures should be followed, with domestic products reported to the local provincial drug supervision and management department, and imported products, as well as those from Hong Kong, Macao, and Taiwan, reported to the management center.
3. It standardizes the requirements for application materials for classification and definition, eliminating the need for paper materials to enable full digitalization. It also specifies the necessary application materials, including product technical requirements, intended product manuals, product photos or videos, conformity statements, and supporting documents. Additionally, it enhances the requirements for filling out the Application Form for Classification and Definition of Medical Devices.
4. It strengthens the supervision of classification implementation by enhancing guidance on classification and definition work and establishing detailed rules and unified definition scales for regulatory hotspots and common issues. It also clarifies the effectiveness of classification and definition results and the disclosure of classification and definition information, with the device standards management center responsible for regular publication.- Flcube.com