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].

Core Viewpoint - The Xinjiang Shawan City Market Supervision Administration is proactively enhancing the quality and safety management of dental clinics by focusing on newly established clinics that have only obtained business licenses without completing medical institution registration or purchasing medical devices and drugs [1] Group 1: Regulatory Actions - The administration is providing regulatory services at the initial stage to help dental clinics establish a solid foundation for drug and device quality management [1] - Enforcement personnel are moving the service focus forward, explaining key aspects such as procurement acceptance, storage maintenance, and record-keeping for commonly used dental devices [1] - On-site demonstrations are conducted to verify supplier qualifications and product registration certificates, ensuring traceability of drug and device sources [1] Group 2: Legal Awareness and Compliance - The administration is distributing legal education materials, using typical cases to explain the legal consequences of improper use of medical devices, thereby raising awareness among clinics [1] - Clinics are encouraged to adopt a "compliance first" business philosophy to maintain the safety baseline for drug and device usage [1] Group 3: Future Plans - The Xinjiang Shawan City Market Supervision Administration plans to extend its proactive guidance services to more medical-related areas, aiming to ensure the quality and safety of medical services for the public [1]