Product Classification

Each country implements classified and graded management for products with different risks. The regulation and control over R&D, manufacturing, operation, registration and full life cycle in clinic is different for products in different categories. To avoid over or insufficient management caused by ambiguous product classification and to provide references for regulatory authorities and reasonable and efficient resource allocation of the enterprise, we provide product classification service for enterprises.
•  Guide for preparation of product classification
•  Track and review the application procedure
•  Communicate and coordinate reasonable classification

Risk Classes IVDR / MDR

9 Authorised Representative BZT AR IVDR MDR UDI

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