{"component": "definition", "props": {"groups": [{"snippet": "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).", "size": 5, "samples": [{"hash": "cmkoNGQpwjC", "uri": "/contracts/cmkoNGQpwjC#technical-file", "label": "Asean Harmonized Electrical and Electronic Equipment Regulatory Agreement", "score": 23.4483230664, "published": true}, {"hash": "dnIZ3hIsgWg", "uri": "/contracts/dnIZ3hIsgWg#technical-file", "label": "Asean Harmonized Electrical and Electronic Equipment Regulatory Regime", "score": 22.2587268994, "published": true}, {"hash": "at4C9Adkwbj", "uri": "/contracts/at4C9Adkwbj#technical-file", "label": "Asean Harmonized Electrical and Electronic Equipment Regulatory Regime", "score": 22.2587268994, "published": true}], "snippet_links": [{"key": "a-supplier", "type": "definition", "offset": [31, 41]}, {"key": "to-maintain", "type": "clause", "offset": [60, 71]}, {"key": "appendix-b", "type": "definition", "offset": [170, 180]}, {"key": "essential-requirements", "type": "clause", "offset": [188, 210]}], "hash": "10a8a5cda4695da71c63adcfe383ad6d", "id": 1}, {"snippet": "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;", "size": 5, "samples": [{"hash": "gQzud8H4Utn", "uri": "https://www.riigiteataja.ee/aktilisa/2021/1202/2009/Appendix_G_Engl.pdf", "label": "www.riigiteataja.ee", "score": 14.8944525899, "published": false}, {"hash": "e6pHuULFHOC", "uri": "https://www.ris.bka.gv.at/Dokumente/BgblAuth/BGBLA_2017_III_160/COO_2026_100_2_1424788.pdfsig", "label": "www.ris.bka.gv.at", "score": 8.8507871321, "published": false}, {"hash": "5QLz1pN7GX1", "uri": "https://360.lexisnexis.at/Attachment/2017_iii_160-coo_2026_100_2_1424788-anlage12/pdf", "label": "360.lexisnexis.at", "score": 8.8507871321, "published": false}], "snippet_links": [{"key": "relating-to", "type": "definition", "offset": [24, 35]}, {"key": "the-vehicle", "type": "clause", "offset": [36, 47]}, {"key": "technical-characteristics", "type": "definition", "offset": [67, 92]}, {"key": "user-manual", "type": "definition", "offset": [106, 117]}, {"key": "the-relevant", "type": "clause", "offset": [205, 217]}], "hash": "c0d5b9d72823f1dd18ca2dd6f6d07488", "id": 2}, {"snippet": "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 \u201ctechnical record\u201d shall be construed as a reference to the technical file;", "size": 4, "samples": [{"hash": "6wg0ii8t9MM", "uri": "https://www.legislation.gov.uk/uksi/2002/1166/part/I/made/data.pdf", "label": "www.legislation.gov.uk", "score": 17.3010411928, "published": false}, {"hash": "ko1J3IFogu1", "uri": "http://www.legislation.gov.uk/uksi/2002/1166/made/data.xht?view=snippet&wrap=true", "label": "www.legislation.gov.uk", "score": 10.1704312115, "published": false}, {"hash": "5PhoFdjMJbT", "uri": "https://www.legislation.gov.uk/uksi/2002/1166/made/data.pdf", "label": "www.legislation.gov.uk", "score": 7.819301848, "published": false}], "snippet_links": [{"key": "relating-to", "type": "definition", "offset": [13, 24]}, {"key": "required-by", "type": "definition", "offset": [75, 86]}, {"key": "the-schedules", "type": "definition", "offset": [158, 171]}, {"key": "a-reference-to", "type": "clause", "offset": [220, 234]}, {"key": "the-technical", "type": "clause", "offset": [235, 248]}], "hash": "c9497c2ccc2b66a9f9fa13786dbf3e37", "id": 3}, {"snippet": "means the documentation which is used to show compliance of a medical device with the requirements of a specific Regulatory Authority.", "size": 3, "samples": [{"hash": "anA3XY64dqT", "uri": "/contracts/anA3XY64dqT#technical-file", "label": "Development and Services Agreement (NeuroMetrix, Inc.)", "score": 28.0622861054, "published": true}, {"hash": "eAG3kq3fr4W", "uri": "https://investor.neurometrix.com/static-files/7fcd1745-7749-4d40-a647-86b26fa24f5f", "label": "investor.neurometrix.com", "score": 11.8872714707, "published": false}, {"hash": "lY0o80CCY8R", "uri": "http://investor.neurometrix.com/static-files/7fcd1745-7749-4d40-a647-86b26fa24f5f", "label": "investor.neurometrix.com", "score": 7.8405201916, "published": false}], "snippet_links": [{"key": "the-requirements", "type": "clause", "offset": [82, 98]}, {"key": "regulatory-authority", "type": "definition", "offset": [113, 133]}], "hash": "5208b7f1c95e6ae40e7a90917192c491", "id": 4}, {"snippet": "means a file relating to a cableway installation which contains the matters required by regulation 4(3)(c);", "size": 3, "samples": [{"hash": "2FSVBbXGGc8", "uri": "https://www.legislation.gov.uk/uksi/2004/129/2008-04-01/data.pdf", "label": "www.legislation.gov.uk", "score": 10.311430527, "published": false}, {"hash": "kdZJvkZn8mX", "uri": "https://www.legislation.gov.uk/uksi/2004/129/made/data.pdf", "label": "www.legislation.gov.uk", "score": 10.2114989733, "published": false}], "snippet_links": [{"key": "relating-to", "type": "definition", "offset": [13, 24]}, {"key": "required-by", "type": "definition", "offset": [76, 87]}], "hash": "dc769bd80b9dd7bc5201046bdccb1c28", "id": 5}, {"snippet": "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.", "size": 2, "samples": [{"hash": "gFv7terxZCL", "uri": "/contracts/gFv7terxZCL#technical-file", "label": "Purchase and Sale Agreement (Bridgetech Holdings International Inc)", "score": 18.0, "published": true}, {"hash": "3S0CjrVxIkN", "uri": "/contracts/3S0CjrVxIkN#technical-file", "label": "Agreement for Purchase and Sale of Rights for Products (Bridgetech Holdings International Inc)", "score": 18.0, "published": true}], "snippet_links": [{"key": "all-information", "type": "clause", "offset": [6, 21]}, {"key": "relating-to", "type": "definition", "offset": [22, 33]}, {"key": "subject-product", "type": "definition", "offset": [36, 51]}, {"key": "quality-specifications", "type": "definition", "offset": [70, 92]}, {"key": "description-of-the", "type": "definition", "offset": [111, 129]}, {"key": "manufacturing-process", "type": "definition", "offset": [130, 151]}, {"key": "production-facilities", "type": "definition", "offset": [176, 197]}, {"key": "the-subject", "type": "clause", "offset": [237, 248]}, {"key": "mutually-agreed", "type": "definition", "offset": [261, 276]}, {"key": "by-the-parties", "type": "clause", "offset": [282, 296]}, {"key": "from-time-to-time", "type": "clause", "offset": [297, 314]}, {"key": "to-receive", "type": "definition", "offset": [361, 371]}, {"key": "regulatory-approval", "type": "clause", "offset": [372, 391]}], "hash": "a9c9c1290b5c24ad7dea64a2253d2a00", "id": 6}, {"snippet": "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.", "size": 2, "samples": [{"hash": "9gdlciXyA0Q", "uri": "https://www.hsa.ie/eng/Legislation/Acts/European_Communities_Act/si407_2008.pdf", "label": "www.hsa.ie", "score": 5.0, "published": false}, {"hash": "jnAviQbgS9R", "uri": "http://www.irishstatutebook.ie/eli/2008/si/407/made/en/pdf", "label": "www.irishstatutebook.ie", "score": 5.0, "published": false}], "snippet_links": [{"key": "the-technical", "type": "clause", "offset": [6, 19]}, {"key": "annex-vii", "type": "definition", "offset": [50, 59]}, {"key": "set-out", "type": "definition", "offset": [112, 119]}, {"key": "schedule-7", "type": "definition", "offset": [123, 133]}], "hash": "e7e9aef1ddfa97749edfbd8664ce2df1", "id": 7}, {"snippet": "means the technical file required to demonstrate that the relevant Goods properly comply with CE marking legislation.", "size": 2, "samples": [{"hash": "cbRZpBvcocL", "uri": "https://static1.squarespace.com/static/5c35d7fff2e6b177eab4e748/t/5e203baa4301a9378dc52a6a/1579170731569/Standard+terms+and+conditions+of+purchase+2019+%28QMSF60%29.pdf", "label": "static1.squarespace.com", "score": 10.015742642, "published": false}, {"hash": "1sBvXS5Uaol", "uri": "https://static1.squarespace.com/static/5c35d7fff2e6b177eab4e748/t/5e203bda245f7758f4720f4b/1579170779094/Standard+TsCs+-+German+law+-+English+Language+2019+%28QMSF60b%29.pdf", "label": "static1.squarespace.com", "score": 8.015742642, "published": false}], "snippet_links": [{"key": "the-technical", "type": "clause", "offset": [6, 19]}, {"key": "the-relevant", "type": "clause", "offset": [54, 66]}, {"key": "comply-with", "type": "definition", "offset": [82, 93]}, {"key": "ce-marking", "type": "definition", "offset": [94, 104]}], "hash": "8fb624ce73995b8b1d9f8be872af9d9d", "id": 8}, {"snippet": "means the technical file as described in clause 18.4(f);", "size": 1, "samples": [{"hash": "6958sClCZNl", "uri": "https://2577f60fe192df40d16a-ab656259048fb93837ecc0ecbcf0c557.ssl.cf3.rackcdn.com/assets/library/document/r/original/rspa_vol_1_published_crl_website.pdf", "label": "2577f60fe192df40d16a-ab656259048fb93837ecc0ecbcf0c557.ssl.cf3.rackcdn.com", "score": 10.4264202601, "published": false}], "snippet_links": [{"key": "the-technical", "type": "clause", "offset": [6, 19]}, {"key": "in-clause", "type": "clause", "offset": [38, 47]}], "hash": "158aba4e028459dc749d86c4f83bb0d7", "id": 9}, {"snippet": "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.", "size": 1, "samples": [{"hash": "8LcCQByqTaK", "uri": "/contracts/8LcCQByqTaK#technical-file", "label": "Certification Agreement", "score": 32.1530196404, "published": true}], "snippet_links": [{"key": "a-list", "type": "definition", "offset": [0, 6]}, {"key": "technical-documents", "type": "definition", "offset": [10, 29]}, {"key": "type-approval-procedures", "type": "clause", "offset": [50, 74]}, {"key": "the-annexes", "type": "clause", "offset": [86, 97]}, {"key": "technical-regulations", "type": "clause", "offset": [111, 132]}, {"key": "for-products", "type": "clause", "offset": [133, 145]}], "hash": "4916149530a8e26918aa13933fde4319", "id": 10}], "next_curs": "ClsSVWoVc35sYXdpbnNpZGVyY29udHJhY3RzcjcLEhpEZWZpbml0aW9uU25pcHBldEdyb3VwX3Y1NiIXdGVjaG5pY2FsLWZpbGUjMDAwMDAwMGEMogECZW4YACAA", "definition": {"snippet": "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).", "size": 37, "title": "Technical File", "id": "technical-file", "examples": ["Services may include, but may not be limited to; analytical services, regulatory affairs and <strong>Technical File</strong> Management of Medical Devices products, subject to and on the terms and conditions of the proposal, and therefore, this agreement.", "The <strong>Technical File</strong> shall specify the applicable requirements and cover as far as relevant for the assessment, the design, manufacture and operation of electrical equipment.", "The <strong>Technical File</strong> shall, wherever applicable, contain at least the requirements specified in Gulf Technical Regulations.", "Client shall prepare and submit <strong>Technical File</strong> and related necessary documents Client shall provide one personnel for assisting the S&amp;Q MART uzman\u0131na 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 <strong>Technical File</strong>.", "If BG Medicine requests these CE Marking services of Corgenix, then, in consideration for the payment set forth in Exhibit F, Corgenix shall use all commercially reasonable efforts to obtain CE Marking certification for any and all Products by performing the tasks as set forth in Exhibit F, which Corgenix shall use all commercially reasonable efforts to complete within two weeks following completion of all tasks required to create the <strong>Technical File</strong> for Product.", "Upon [***] advance written notice, Supplier will provide information contained in its <strong>Technical File</strong>, as requested by OEM and will permit OEM or its representative to visit Supplier\u2019s premises and conduct an audit of Supplier\u2019s premises and processes, which will include, but is not limited to, [***].", "Seller agrees that each <strong>Technical File</strong> may be used by Bridgetech and its customers for filings with all Regulatory Authorities.", "SRC must either: \u2022 prepare the <strong>Technical File</strong> or \u2022 provide to Broncus upon request, all necessary product design specifications, design test data, production process, inspection/test procedure, labeling, clinical data, post market performance data, and other information needed for Broncus to prepare the <strong>Technical File</strong> for Broncus product.", "<strong>Technical File</strong> for [***] and the [***] completed with internal data."], "related": [["personnel-file", "Personnel file", "Personnel file"], ["data-file", "Data File", "Data File"], ["technical-data", "Technical Data", "Technical Data"], ["case-file", "Case file", "Case file"], ["technical-specification", "technical specification", "technical specification"]], "related_snippets": [], "updated": "2025-07-06T21:58:36+00:00"}, "json": true, "cursor": ""}}