Why Reconstruction Is Required
When product functions, output parameters, instructions, test evidence and market claims cannot support one another, removing medical wording alone does not change the product’s actual status. Compliance reconstruction turns regulatory requirements into real product-design and operating boundaries.
Scope of Reconstruction
- Product name and intended-purpose design
- Principal mechanism and function-set analysis
- Adjustment of output parameters, levels, treatment duration and control logic
- Design of treatment areas, user population, contraindications and warnings
- Instructions, risk analysis and verification-evidence matrix
- Boundaries for sales, distribution, training and e-commerce claims
Core Principle
All submitted materials must match the product actually manufactured, imported, sold and used. Products genuinely intended for diagnosis, treatment, alleviation, prevention or rehabilitation should follow the medical-device registration pathway.
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.