Core Viewpoint - The Inner Mongolia Drug Administration has introduced the "Quality Management Points for Additive Manufacturing Laser Melting Customized Dentures," effective from January 1, 2026, to enhance quality management and standardize registration applications for dental enterprises using additive manufacturing technology [1][2]. Group 1: Quality Management Points - The "Quality Management Points" address quality safety risks and regulatory challenges associated with the increasing use of additive manufacturing technology in customized denture production [1]. - The document outlines management requirements for enterprises producing customized dentures using laser melting technology, covering eight aspects including facility equipment, design development, procurement, production management, and quality control [1]. - The applicable products include metal crowns, fixed bridges, inlays, posts, removable partial denture frameworks, and complete denture bases made from legally registered materials such as cobalt-chromium alloy, titanium, and titanium alloys [1]. Group 2: Implementation and Impact - The drug regulatory department and enterprises will implement the "Quality Management Points" alongside existing regulations such as the "Medical Device Production Quality Management Standards" and its appendix for customized dentures [2]. - The introduction of these management points is expected to promote standardized production organization among related enterprises, enhance quality management levels, and guide the industry towards orderly and healthy development [2].