Technical File definition

Technical File means a set of document, which a supplier is obliged by law to maintain and which demonstrates that a regulated product has been tested and certified for compliance with Appendix B (ASEAN Essential Requirements).
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Technical File means the documentation relating to the vehicle containing all its technical characteristics, including a user manual and the characteristics necessary to identify the object(s) concerned, as described in the relevant UTP;
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Technical File means a file relating to a structural subsystem which contains the matters required by regulation 13(9) and regulation 24(1)(b) and (c), and any reference in the schedules to the “technical record” shall be construed as a reference to the technical file;
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Examples of Technical File in a sentence

  • Services may include, but may not be limited to; analytical services, regulatory affairs and Technical File Management of Medical Devices products, subject to and on the terms and conditions of the proposal, and therefore, this agreement.

  • The Technical File shall specify the applicable requirements and cover as far as relevant for the assessment, the design, manufacture and operation of electrical equipment.

  • The Technical File shall, wherever applicable, contain at least the requirements specified in Gulf Technical Regulations.

  • Client shall prepare and submit Technical File and related necessary documents Client shall provide one personnel for assisting the S&Q MART uzmanına during the inspections.

  • Changes in Specifications, manufacturing, including change of sterilization process or provider, labeling, or packaging agreed to by Collagen and ArthroCare may result in amendments to the Technical File.


More Definitions of Technical File

Technical File means the documentation which is used to show compliance of a medical device with the requirements of a specific Regulatory Authority.
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Technical File means a file relating to a cableway installation which contains the matters required by regulation 4(3)(c);
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Technical File means all information relating to a Subject Product and including the quality specifications and analyses, the description of the manufacturing process, the description of the production facilities and organization, and the packaging of the Subject Product, as mutually agreed upon by the parties from time to time, as necessary to support Bridgetech's efforts to receive regulatory approval for said Subject Product.
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Technical File means the technical file referred to in part A of Annex VII, the text of which Annex is, for ease of reference, set out in Schedule 7.
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Technical File means the technical file required to demonstrate that the relevant Goods properly comply with CE marking legislation.
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Technical File means the technical file as described in clause 18.4(f);
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Technical File. A list of technical documents detailed within the Type approval procedures defined by the Annexes of the Saudi technical regulations for products, so to enable the Approved Body to carry out a Type examination.
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