해외 기술자료 이해
Identify the actual product boundaries from manuals, specifications, software controls, accessories, and test records—not through language translation alone.
BEAUTY TECHNOLOGY COMPLIANCE
美容设备合规产品工程
从产品属性判断，到研发重构、实验验证与市场准入。基本定律帮助企业建立与真实产品一致、能够持续执行的合规路径。
Imported microcurrent NMPA case work
Ultrasound and ion-air projects in progress
Domestic microcurrent project in progress
SELECT YOUR STARTING POINT
Different companies face different challenges. Choose the entry point closest to your current stage.
01 / IMPORT TO CHINA
해외 제조사 및 중국 대리인
For products already marketed overseas and planned for China: determine regulatory status, rebuild Chinese materials, and establish an NMPA classification path.
수입기기 중국 규제 경로 보기 02 / DOMESTIC R&D중국 내 연구개발·제조 기업
For products at concept, prototype, or redesign stage: confirm that functions and parameters match the intended regulatory route before testing and mass production.
연구개발 단계 규제 경로 진단 03 / MARKET CONTINUITY출시 제품 및 브랜드사
For marketed products: maintain consistency across instructions, product updates, partner training, and distributor promotion.
출시 후 컴플라이언스 관리
IMPORT DEVICE COMPLIANCE
01
02
03
수입 기기는 Basic Law의 핵심 전문 업무 중 하나입니다.
The main challenge is not only the applicant or authorization documents, but whether the overseas product definition can be translated into a product logic that Chinese regulators can understand, verify, and consistently implement.
중국 버전 구축
Reorganize the product name, intended purpose, operating principle, parameter ranges, risk controls, and Chinese instructions according to China’s classification logic.
장기 프로젝트 관리
Use the project platform to manage document versions, supplementary questions, verification tasks, client approvals, and regulatory communications.
OVERSEAS PRODUCTCHINA MARKET
TECHNICAL DOSSIEROverseas Technical DossierManual · Specification · Test
REGULATORY TRANSLATION
01제품 정의Name / Intended use
02근거 체계Risk / Verification
03분류 경로NMPA / Market entry
04운영 일관성Label / Marketing
REPRESENTATIVE PRACTICE
대표 프로젝트 사례
Public cases illustrate project types and methods. Completed and ongoing projects are clearly identified, and no single case replaces an independent assessment of a specific product.
RF
不作为医疗器械管理
MC
不作为医疗器械管理
LED
不作为医疗器械管理
PHASED ENGAGEMENT
단계별 의사결정으로 초기 투자를 관리합니다.
Complex devices should not enter a full submission process before sufficient information is available. Our staged approach provides a clear conclusion at each key decision point.
자료 조건 확인
Confirm whether the available product information supports an assessment, identify material gaps, and determine whether formal technical diagnosis is required.
Reduce ineffective communication and false starts정식 규제 경로 진단
Define regulatory-status risks, adjustment directions, evidence needs, project duration, and the scope of subsequent work for management decision-making.
Proceed based on a clear conclusion제품 재구성 및 신청 실행
Once the route is viable, proceed with product reconstruction, verification, classification, and market-consistency management.
Invest only in an executable path서비스 비용 안내
Fees depend on the technology, dossier completeness, product redesign, verification needs, importing entity, and submission level. Fees reflect professional judgment, product reconstruction, evidence development, and long-cycle project management—not document count. Scope, deliverables, and payment milestones are confirmed before formal engagement.
PROFESSIONAL SERVICES
시장 진입을 위한 종합 서비스
China compliance for imported devices is a priority practice. Domestic projects proceed in stages from path diagnosis and product reconstruction to classification.
前期评估
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。
서비스 범위 보기 핵심 서비스제품 규정 준수 재구성
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。
서비스 범위 보기 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。
서비스 범위 보기 지속 관리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。
서비스 범위 보기 중점 서비스 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。
서비스 범위 보기
BASIC LAW METHOD
규제 판단은 실제 제품에 근거해야 합니다.
We place intended purpose, mechanism of action, technical parameters, risk controls, verification, and commercial operation within one coherent logic. Any inconsistency becomes a future project risk.
01
용도 정의Confirm target users, use settings, and non-medical purpose.
02
작용 원리 설명Identify the primary action and possible physiological effects.
03
기술 경계 설정Verify frequency, current, energy, temperature, pressure, and time.
04
위험 관리Implement structural, software, operational, and warning controls.
05
근거 구축Support the product definition and submission rationale with verification evidence.
06
일관성 유지Align instructions, training, e-commerce content, and product updates.
CORE EXPERTISE
복합 작용 메커니즘 제품 전문 분야
Our project work currently covers imported and domestic microcurrent devices, ultrasound and ion-air technologies, while continuing to develop evidence methods for radiofrequency, light-based, delivery and combination devices.
能量型设备
Radiofrequency Beauty Devices
重点处理射频能量输出、皮肤温升、作用机制、使用场景和医疗化宣称之间的关系。
- 频率与波形
- 输出功率与能量
- 皮肤温升和作用深度
电刺激设备
微电流与EMS设备
围绕微电流、脉冲电流、肌肉刺激和皮肤护理用途，建立产品参数与预期用途的一致性。
- 电流强度与电压
- 频率和脉冲波形
- 电极接触方式
导入型设备
超声与美容导入设备
处理超声频率、声强、接触介质、导入用途和组织作用之间的产品定义问题。
- 超声频率与声强
- 空化和热效应
- 接触介质
Light-based Devices
Light-based Beauty Devices
处理LED、宽谱光及其他光类美容设备的能量、温升、皮肤反应和用途边界。
- 波长与光谱
- 能量密度
- 照射距离和时间
透皮导入设备
Electroporation and Pneumatic-delivery Devices
围绕电脉冲、气压喷射、耗材液体和皮肤接触方式，判断导入设备的真实作用与监管路径。
- 电脉冲或气压参数
- 皮肤完整性
- 使用液体和耗材
组合型设备
Combination Beauty Devices
针对射频、微电流、超声、光、冷热、负压和振动等多功能组合设备进行系统判断。
- 主作用机制
- 功能独立或联动
- 最不利参数组合
COMPLIANCE INSIGHTS
전체 보기
경영진·연구개발팀을 위한 규제 인사이트
Translate regulatory changes, product mechanisms, and project experience into clear information for project initiation, redesign, budgeting, and market-entry decisions.
01경영진Path and investment decisions
02연구개발팀Parameter and evidence boundaries
03마케팅팀Claims and operational consistency