Ein nachhaltiges Produkt-Compliance-System aufbauen.
Basic Law specialises in bringing imported beauty devices into China and provides staged services for domestic R&D and manufacturing companies, from project assessment and product reconstruction to classification and post-market management.
Nicht jedes Projekt sollte unmittelbar in eine vollständige Einreichung übergehen.
Complex beauty devices vary greatly in mechanism, dossier readiness, and target market. We first confirm the available information, then use a formal pathway diagnosis to clarify status risk, modification scope, testing needs, and subsequent budget. Companies can decide whether to continue after receiving defined deliverables at each key stage.
Regulatory Pathway Assessment
从预期用途、作用原理、输出参数、人体接触方式和使用场景出发，识别产品进入医疗器械或非医疗器械路径的关键条件。
LeistungsumfangKernleistungenCompliance-orientierte Produktanpassung
围绕名称、预期用途、功能组合、输出参数、说明书、风险控制和实验体系，对产品进行真实、可执行的合规调整。
Leistungsumfang申报管理分类界定申报
围绕产品用途、原理、参数、风险和验证资料构建分类界定申报体系，并协助完成补充资料和项目沟通。
LeistungsumfangLaufende Compliance上市后年度合规
持续审查说明书、电商页面、招商材料、培训话术和产品升级内容，保持实际产品、认定资料和市场宣传一致。
LeistungsumfangSchwerpunktleistung国际业务美容设备进口与出口路径
提供进口美容设备中国属性认定、欧盟 MDR Annex XVI 边界判断、美国低风险健康产品初评及多市场产品定义。
LeistungsumfangDas Honorar richtet sich nach der Projektkomplexität.
Fees are determined by technical mechanism, dossier completeness, modification scope, testing requirements, import entity, submission level, and project duration. Basic Law prices the actual scope of professional judgement, product reconstruction, evidence building, and end-to-end project management rather than standardised document preparation.
Unterlagen einreichen und Projektstart klären