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“光谱透射比”不符合标准 蔡司一款人工晶体被取消集采中选资格
Bei Ke Cai Jing· 2025-10-30 05:43
Core Viewpoint - The National Organization for High-Value Medical Consumables Joint Procurement Office announced the disqualification of Carl Zeiss Meditec AG from the fourth batch of national high-value medical consumables procurement due to non-compliance with product quality standards [1]. Group 1: Company Actions - Carl Zeiss Meditec AG's intraocular lens (bifocal non-astigmatic lens) was found to have a "spectral transmittance ratio" that did not meet the required standards during a quality supervision inspection by the drug regulatory authority [1]. - The decision to disqualify the company was made collectively by relevant member units of the National Organization for High-Value Medical Consumables Joint Procurement Office after reviewing the violations of procurement guidelines [1]. Group 2: Regulatory Context - The disqualification is in accordance with the guidelines set forth by the National Medical Insurance Administration and eight other departments regarding the centralized procurement and use of high-value medical consumables [1]. - The procurement document number GH-HD2023-1 outlines the specific terms that Carl Zeiss Meditec AG violated, leading to the cancellation of its qualification for the procurement [1].