Service Objective
Before formal development, importation, submission or market investment, we assess the product’s actual regulatory status and pathway feasibility. This helps companies avoid discovering—after the product has been finalised—that its functions, parameters or claims conflict with the intended regulatory route.
Key Areas of Analysis
- Product name, target users, use setting and proposed intended purpose
- Operating principle, structural composition, output form and body contact
- Frequency, current, voltage, power, energy, temperature, pressure and treatment duration
- Whether the product involves treatment, repair, rehabilitation, disease or pathological/physiological changes
- Differences between domestic China, imported China, EU and US market pathways
Deliverables
- Preliminary regulatory-status assessment and risk rating
- Comparison of medical-device and non-medical pathway feasibility
- List of high-risk functions, parameters and claims
- Product adjustment direction and scope of the next phase
For complex devices requiring technical dossier review, pathway analysis and redesign recommendations, formal diagnosis is a separate paid service and is not replaced by general consultation.
Product status and classification decisions are made by the competent authority based on the actual product and formal dossier. Basic Law provides regulatory-path, product reconstruction, evidence-building, and project-management services and does not replace the authority’s administrative judgement.