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.
See how Basic Law handles complex devices through the product, regulatory challenge, working pathway and final outcome.
Basic Law supported product reconstruction and classification by analysing the RF mechanism, energy parameters, skin safety and intended purpose.
View Full ProjectThe project involved multiple rounds of technical analysis and supplementary testing to align the actual imported product with its China submission dossier.
View Full ProjectBasic Law helped the client organise technical parameters, skin safety and non-medical aesthetic use into a reviewable product dossier.
View Full ProjectYou do not need to identify the professional service first. Start with the product origin and target market.
Review overseas documents against the actual product and establish the China product definition, Chinese dossier, evidence system and classification pathway.
View China Entry Path for Imported Devices 02 / DOMESTIC CLASSIFICATIONConfirm product status during R&D, redesign or submission; align uses, parameters, documents and verification evidence; and advance provincial or national classification determination.
View the Domestic Classification Pathway 03 / EU & US MARKETAssess EU MDR and Annex XVI, as well as US medical-device and low-risk wellness boundaries, to define product versions, testing and market-entry requirements.
View EU and US Compliance PathwaysThe homepage provides only an overview of the method.Formal projects proceed in stages according to product facts, target markets and evidence needs.
Enter the relevant expertise page by actual mechanism to review parameter boundaries, dossier priorities and common regulatory risks.
View All ExpertisePractical information for project initiation, redesign, budgeting and market entry.
View AllDifferences in output, handpieces, software, model, intended purpose or companion products can limit the applicability of the classification result and create platform, complaint, regulatory and contractual risks.
Read MoreA non-medical classification result applies to a defined product fact pattern. It does not exempt product quality, advertising, consumer, import, corporate or post-market-change obligations.
Read MoreFirst identify the exact SKU, model, page and claim being questioned. Submit a package consistent with the product actually sold rather than relying on a single result for another version.
Read MoreSubmit the instructions, intended purpose, operating principle, key technical parameters and target market. We will first review the product facts and project conditions.
