Importing into China
We help overseas manufacturers and China representatives organise intended purpose, technical documentation, authorisation relationships and the NMPA classification-determination pathway.
European Union
We focus on whether the product may fall within MDR Annex XVI, whether a notified body may be required, whether product modifications could change the route, and whether separate China and EU versions are needed.
United States
We conduct a preliminary boundary assessment of low-risk general wellness positioning and whether the product involves disease or medical purposes. Formal FDA work is handled by qualified US specialist partners where required.
Service Boundary
Basic Law is responsible for overall regulatory-pathway strategy and China-side project management. We do not present ourselves as a global certification body for every product category, and we do not claim that all beauty devices can enter overseas markets as non-medical products.