REGULATORY & PRODUCT SERVICE

Product Classification Determination Submission

Use a complete product evidence system to explain why the product should follow the proposed regulatory route.

Service Scope

  • Classification-determination dossier checklist and version control
  • Product description, structural composition, operating principle and intended-purpose documents
  • Comparable products, classification catalogue and regulatory-status rationale
  • Risk analysis, verification evidence and supporting documentation
  • Analysis and response to supplementary-information requests
  • Management of project progress, client tasks and file delivery

Domestic and Imported Projects

Domestic and imported devices differ in applicant, review level, documentation and communication route. Before project launch, the plan must be determined separately according to the manufacturer, the actual product status and the target market.

Outcome Boundary

The competent authority determines classification based on the submitted dossier and the actual product. Basic Law does not describe this service as “obtaining a certificate” and does not guarantee approval.

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.
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