新疆新疆沙湾市市监局问诊把脉开良方 精准监管护好医疗器械安全线

Core Viewpoint - The Xinjiang Shawan City Market Supervision Bureau is implementing a "diagnostic" regulatory model to enhance the safety of medical device operations, particularly for vulnerable groups such as the elderly [1] Group 1: Regulatory Actions - The regulatory focus is on experiential medical devices, ensuring compliance with qualifications, purchase verification, sales records, product storage and transportation safety, and traceability systems [1] - Specific attention is given to verifying product registration, purchase checks, sales records, and the fulfillment of consumer information obligations, especially regarding misleading advertising aimed at the elderly [1] Group 2: Enforcement Measures - Issues identified during inspections, such as incomplete sales records and inappropriate promotional language, result in immediate corrective actions, including the issuance of rectification notices with specified deadlines and responsible parties [1] - Legal education is conducted alongside inspections, emphasizing the Medical Device Supervision and Administration Regulations and urging companies to accurately inform vulnerable groups about product usage and contraindications [1] Group 3: Future Plans - The Xinjiang Shawan City Market Supervision Bureau plans to institutionalize the "diagnostic" regulatory approach, increasing the frequency of inspections on medical device experience stores and focusing on risks associated with elderly users [1] - The goal is to continuously improve regulatory precision and ensure the safety of medical device usage for the public [1]