【海南出台医疗器械委托生产监管新政】近日,海南省药监局印发《关于严格落实医疗器械注册人委托生产主体责任强化全生命周期质量监管的若干措施》,通过进一步划清政企权责边界、明确企业合规路径、细化监管履职标准,补齐委托生产监管短板,着力构建权责清晰、全程可控、协同高效、常态长效的委托生产监管新格局。 自2021年版《医疗器械监督管理条例》实施以来,医疗器械注册人制度全面落地。随着注册人制度改革红利持续释放,委托生产已成为海南省医疗器械产业重要发展模式。目前,我省近45%的注册人企业涉及委托生产,受托生产企业遍布全国14个省市,产业外向度高、跨区域协作特征显著。
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