中国质量新闻网讯 近日，山东省泰安市泰山区市场监管局对辖区内第一类医疗器械（护具类）生产企业开展监督检查。
此次检查，聚焦医用固定带、医用护腰、医用护膝等一类护具产品，以备案合规、原料管控、生产过程、质量检验、标签说明书为重点，采取现场核查、台账查阅、车间巡查、实物比对等方式，全面排查质量安全风险。执法人员重点核查企业第一类医疗器械生产备案与产品备案是否真实有效、生产条件是否持续符合备案要求，原材料采购验收、供应商管理是否规范，生产工艺流程、质量控制记录是否完整可追溯，产品标签、说明书是否与备案内容一致，严禁超范围生产、虚假标注、夸大适用范围等违规行为。检查同步开展法规宣传，指导企业严格落实《医疗器械监督管理条例》《医疗器械生产质量管理规范》要求，健全质量管控体系，提升合规生产水平。
下一步，泰安市泰山区市场监管局将持续强化一类医疗器械全链条监管，常态化开展备案后核查与“回头看”，以严标准、实举措守护护具产品质量安全，为群众健康保驾护航。（王茜茜）
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