Understand the Overseas Dossier
Identify the actual product boundaries from manuals, specifications, software controls, accessories, and test records—not through language translation alone.
BEAUTY TECHNOLOGY COMPLIANCE
Beauty Device Compliance Product Engineering
From regulatory-status assessment to product reconstruction, verification and market access, Basic Law helps companies build an executable compliance pathway that matches the real product.
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
Overseas Manufacturers and China Representatives
For products already marketed overseas and planned for China: determine regulatory status, rebuild Chinese materials, and establish an NMPA classification path.
View China Entry Path for Imported Devices 02 / DOMESTIC R&DDomestic R&D and Manufacturers
For products at concept, prototype, or redesign stage: confirm that functions and parameters match the intended regulatory route before testing and mass production.
View R&D-Stage Path Assessment 03 / MARKET CONTINUITYMarketed Products and Brand Owners
For marketed products: maintain consistency across instructions, product updates, partner training, and distributor promotion.
View Post-Market Compliance Management
IMPORT DEVICE COMPLIANCE
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Imported devices are one of Basic Law’s core specialist practices.
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.
Build the China Version
Reorganize the product name, intended purpose, operating principle, parameter ranges, risk controls, and Chinese instructions according to China’s classification logic.
Manage Long-Cycle Projects
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
01Product DefinitionName / Intended use
02Evidence SystemRisk / Verification
03Classification PathNMPA / Market entry
04Commercial ConsistencyLabel / Marketing
REPRESENTATIVE PRACTICE
Representative Case Work
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
Not Regulated as a Medical Device
Radiofrequency Devices
27 MHz RF Delivery Device Regulatory-status Project
Basic Law supported product reconstruction and classification by analysing the RF mechanism, energy parameters, skin safety and intended purpose.
View Project Method
MC
Not Regulated as a Medical Device
Imported Microcurrent
Imported Microcurrent Wellness Device Regulatory-status Project
The project involved multiple rounds of technical analysis and supplementary testing to align the actual imported product with its China submission dossier.
View Project Method
LED
Not Regulated as a Medical Device
Light-based Devices
“Milk Light” Light-based Beauty-care Device Regulatory-status Project
Basic Law helped the client organise technical parameters, skin safety and non-medical aesthetic use into a reviewable product dossier.
View Project Method
PHASED ENGAGEMENT
Make decisions in stages and control early investment.
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.
Dossier Readiness Review
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 startsFormal Regulatory Path Diagnosis
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 conclusionProduct Reconstruction and Submission
Once the route is viable, proceed with product reconstruction, verification, classification, and market-consistency management.
Invest only in an executable pathAbout Service Fees
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
A complete service chain for market entry
China compliance for imported devices is a priority practice. Domestic projects proceed in stages from path diagnosis and product reconstruction to classification.
Preliminary Assessment
Regulatory Pathway Assessment
Assess intended purpose, mechanism, output parameters, body contact and use setting to identify the conditions for a medical-device or non-medical pathway.
View Service Scope Core ServiceProduct Compliance Reconstruction
Create a genuine and executable product version by aligning the name, intended purpose, function set, output parameters, instructions, risk controls and evidence system.
View Service Scope Submission ManagementProduct Classification Determination Submission
Build a classification-determination dossier around product purpose, mechanism, parameters, risks and verification evidence, and support supplementary submissions and project communication.
View Service Scope Ongoing ManagementAnnual Post-market Compliance Management
Continuously review instructions, e-commerce pages, distribution materials, training scripts and product updates to keep the actual product, determination dossier and market claims aligned.
View Service Scope Priority Service International BusinessImport and Export Regulatory Pathways for Beauty Devices
Support China regulatory-status assessment for imported beauty devices, EU MDR Annex XVI boundary assessment, preliminary US low-risk wellness positioning and multi-market product definition.
View Service Scope
BASIC LAW METHOD
Regulatory conclusions must be traceable to the real product.
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.
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Define PurposeConfirm target users, use settings, and non-medical purpose.
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Explain the MechanismIdentify the primary action and possible physiological effects.
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Set Technical BoundariesVerify frequency, current, energy, temperature, pressure, and time.
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Control RiskImplement structural, software, operational, and warning controls.
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Build EvidenceSupport the product definition and submission rationale with verification evidence.
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Maintain ConsistencyAlign instructions, training, e-commerce content, and product updates.
CORE EXPERTISE
Expertise in products with complex mechanisms
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.
Energy-based Devices
Radiofrequency Beauty Devices
Address the relationship among RF output, skin temperature rise, mechanism, use setting and medical-style claims.
- Frequency and waveform
- Output power and energy
- Skin temperature rise and depth of action
Electrical-stimulation Devices
Microcurrent and EMS Devices
Align product parameters and intended purpose for microcurrent, pulsed-current, muscle-stimulation and skin-care applications.
- Current and voltage
- Frequency and pulse waveform
- Electrode contact method
Delivery Devices
Ultrasound and Beauty-delivery Devices
Address product-definition issues involving ultrasound frequency, intensity, coupling media, delivery purposes and tissue effects.
- Ultrasound frequency and intensity
- Cavitation and thermal effects
- Coupling media
Light-energy Devices
Light-based Beauty Devices
Address energy, temperature rise, skin response and intended-purpose boundaries for LED, broad-spectrum and other light-based beauty devices.
- Wavelength and spectrum
- Energy density
- Exposure distance and duration
Transdermal-delivery Devices
Electroporation and Pneumatic-delivery Devices
Assess the actual action and regulatory pathway of delivery devices using electrical pulses, pneumatic jets, consumable liquids and skin contact.
- Electrical-pulse or pneumatic parameters
- Skin integrity
- Liquids and consumables
Combination Devices
Combination Beauty Devices
Systematically assess multifunction devices combining RF, microcurrent, ultrasound, light, heating/cooling, vacuum and vibration.
- Principal mechanism
- Independent or linked functions
- Worst-case parameter combinations
COMPLIANCE INSIGHTS
View All
Compliance insights for management and R&D teams
Translate regulatory changes, product mechanisms, and project experience into clear information for project initiation, redesign, budgeting, and market-entry decisions.
01ManagementPath and investment decisions
02R&D TeamParameter and evidence boundaries
03Marketing TeamClaims and operational consistency