Start with product facts and build an executable compliance pathway.
Basic Law provides staged services for imported devices entering China, non-medical classification of domestic devices and Chinese devices entering EU and US markets—from assessment and product reconstruction to evidence, submission and market-use boundary management.
First confirm whether the product is suitable for a project.
Not every complex device should enter a full submission immediately. We first review document readiness and the real product boundary to determine whether a viable regulatory pathway exists, what must change, and whether verification and formal submission are needed.
How the Project Proceeds
The four stages serve one objective: keeping the actual product, formal documents and market use consistent.
Import 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 ScopePreliminary AssessmentRegulatory 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 ScopeCore 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 ScopeSubmission 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 ScopeOngoing 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 ScopeEvery compliance project should begin with real and complete product information.
Submit the product instructions, operating principle, intended purpose, key technical parameters and target market. We will first review the product facts, regulatory boundaries and project conditions before confirming formal assessment. Submission does not automatically initiate a project or constitute a product-status conclusion.
Submit Information and Confirm the Project Starting Point