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为加强医疗器械质量监督管理,保障医疗器械产品使用安全有效,国家食品药品监督管理总局组织对天然胶乳橡胶避孕套等5个品种81批(台)的产品进行了质量监督抽验。一、被抽验项目不符合标准规定的医疗器械产品,涉及3家医疗器械生产企业的3个品种3批(台)。二、被抽验项目为标识标签、说明书等项目不符合标准规定的医疗器械产品,涉及1家医疗器械生产企业的1个品种1台。三、抽验项目全部符合标准规定的医疗器械产品涉及1个品种77批次。四、对上述抽验中发现的不符合标准规定产品,国家食品药品监督管理总局已要求企业所在地食品药品监督管理部门
In order to strengthen the supervision and management of medical device quality and ensure the safe and effective use of medical device products, the State Food and Drug Administration organized a quality supervision and inspection of 81 batches (sets) of five varieties of natural rubber latex condoms. 1. The medical device products that were not subject to the standard test by the selected sample project involved 3 batches of 3 varieties (Taiwan) of the 3 medical device manufacturing enterprises. 2. The sampled items are medical device products whose labels, instructions and other items do not meet the requirements of the standard, and involve 1 set of 1 medical device manufacturer. 3. The medical device products that meet all the requirements of the sampling inspection project involve 77 batches of one species. 4. Regarding the products found to be inconsistent with the standards specified in the above-mentioned random inspection, the State Food and Drug Administration has requested the local food and drug supervision and administration department