{"editorial":{"content_id":"08b1bdfb-f3c0-4571-8061-112c2ec6311b","slug":"anvisa-safe-life-wcr-20261103-400223","content_type":"news","title":"巴西Anvisa暂停Safe Life公司WCR放疗设备全部批次","summary":"巴西国家卫生监督局于11月3日暂停Safe Life公司自2026年9月16日起生产的WCR皮肤癌浅表放疗设备全部批次，并同样处罚加拿大Best Theratronics公司的两款血液辐照器。","body":"巴西国家卫生监督局（Anvisa）于11月3日（星期二）暂停了Safe Life Distribuidora de Produtos para Saúde Ltda（CNPJ: 34.192.854/0001-39）生产的WCR医疗器械自2026年9月16日起生产的全部批次。该产品用于皮肤癌的浅表放射治疗。\n\nAnvisa表示，8月31日至9月2日对该企业进行的卫生检查证实，其生产不符合董事会决议（RDC）665/2022和6.437/1977号法律。相关产品不得生产、储存、分销、销售、宣传或使用。\n\n同样的处罚也适用于Best Theratronics Ltd（位于加拿大）自2026年8月5日起生产的带条形码阅读器的血液辐照器和X射线血液辐照器。Anvisa称，该制造商拒绝接受医疗器械单一审计计划（MDSAP）的审计，该计划由Anvisa与美国、新加坡、英国和日本等国际机构共同参与。\n\n相关决议RE 4.256/2026和RE 4.262/2026已在《联邦官方公报》（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","行业趋势","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":"2026-11-03T17:01:08.470Z","display_date":"2026-11-03","source_published_at":null,"source_url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-suspende-equipamento-para-radioterapia-superficial","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-safe-life-wcr-20261103-400223","api_url":"https://chinabrazilinsight.com/api/public/content/anvisa-safe-life-wcr-20261103-400223","markdown_url":"https://chinabrazilinsight.com/api/public/content/anvisa-safe-life-wcr-20261103-400223?view=markdown","json_url":"https://chinabrazilinsight.com/api/public/content/anvisa-safe-life-wcr-20261103-400223?view=json","last_updated":"2026-11-03T17:01:33.276Z","platform":"China Brazil Insight","platform_url":"https://chinabrazilinsight.com"}}