TYPE EXAMINATION definition
TYPE EXAMINATION. Is the part of a conformity assessment procedure in which a Conformity Assessment Body examines the technical design of a product, verifies that the technical design of the product meets the requirements of the applicable SASO Technical Regulations that apply to it. Referred to as Type in this Agreement.
TYPE EXAMINATION is a means of demonstrating compliance with relevant Essential Principles of Safety and Performance of Medical Devices. One or more representative units of the device (i.e. the “type”) chosen by the manufacturer (e.g. final prototypes representative of the production configuration), together with relevant technical documentation, are submitted to a comprehensive examination by a CAB to confirm compliance.
TYPE EXAMINATION. Is the part of a conformity assessment procedure in which an approved Conformity Assessment Body examines the technical design of a product, verifies, and attests that the technical design of the product meets the requirements of the applicable Saudi Technical Regulations and/or standards.