{"editorial":{"content_id":"18bce731-94f1-4322-b64e-740c36f39227","slug":"anvisa-20261023-433627","content_type":"news","title":"Anvisa暂停多款违规医疗器械并下令召回","summary":"巴西国家卫生监督局暂停多款违规医疗器械的销售、进口、宣传和使用，并下令召回部分产品。","body":"巴西国家卫生监督局（Anvisa）于10月23日（周五）暂停了多款违规医疗器械，相关措施已在联邦官方公报（DOU）上公布。\n\n被暂停的产品包括Rota-Strip轮状病毒抗原快速诊断检测试剂。应Nanosens Ltda公司请求对制造商Coris Bioconcept进行检查后，确认其生产不符合现行规范，因此自2026年2月9日起生产的该检测试剂的销售、进口、宣传和使用均被暂停。\n\n2026年2月2日至5日对Precision Concepts Costa Rica S.A（商号Biomerics Alajuela）进行卫生检查，发现其违反Anvisa规范及第6.437/1977号法律。据此，Anvisa决定召回自2026年2月5日起生产的CLOSURERFS Covidien射频静脉消融刀，并暂停该产品的生产、销售、分销、宣传和使用。\n\nAnvisa还决定召回Becton Dickinson Indústrias Cirúrgicas Ltda.（CNPJ: 21.551.379/0001-06）生产的BD Angioccath医疗器械，并暂停其销售、分销和使用。Ezequiel Dias基金会（FUNED）出具的报告显示，该产品在表面验证测试中结果不合格。\n\n相关措施依据RE 4.151/2026、RE 4.153/2026、RE 4.154/2026和RE 4.157/2026号决议，已在DOU上公布。","why_it_matters":null,"cbi_observation":null,"direction_tag":"巴西","primary_category":"科技平台","secondary_topics":["合规","政策","法律","br-health"],"content_level":"编辑整理","event_type":"政策法规","audience_tags":[],"event_location":null,"verification_status":"source_verified","published_at":"2026-10-23T17:01:22.602Z","display_date":"2026-10-23","source_published_at":null,"source_url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-proibe-e-determina-recolhimento-de-dispositivos-medicos","source_name":"Anvisa","source_language":"pt","author_name":"编辑部","risk_level":"low","risk_flags":[],"opportunity_flags":[],"trend_signals":[]},"intelligence":null,"meta":{"canonical_url":"https://chinabrazilinsight.com/news/anvisa-20261023-433627","api_url":"https://chinabrazilinsight.com/api/public/content/anvisa-20261023-433627","markdown_url":"https://chinabrazilinsight.com/api/public/content/anvisa-20261023-433627?view=markdown","json_url":"https://chinabrazilinsight.com/api/public/content/anvisa-20261023-433627?view=json","last_updated":"2026-10-23T17:01:48.136Z","platform":"China Brazil Insight","platform_url":"https://chinabrazilinsight.com"}}