上海欧杰与国际知名医疗认证集团合作，面向中国用户提供一下MDR TD文件销售服务，有需要的可以和我们业务部门联系
Class I Technical File Templates (Including Is / Im / Ir)
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Active Device - Non-Sterile with / without Software
Document ID : TD-01
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Non-Active Device - Non-Sterile
Document ID : TD-02
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Non-Active Device - Sterile / Measuring / Reusable
Document ID : TD-03
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Active Device - Sterile / Measuring / Reusable
Document ID : TD-04
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Software Device with or without Measuring Function
Document ID : TD-05
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Class IIa Technical File Templates
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Active Device - Sterile / Non-Sterile / Measuring / Reusable /with / without Software
Document ID : TD-06
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Non-Active Device - Sterile / Non-Sterile / Measuring / Reusable
Document ID : TD-07
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Non-Active Device - Implant Sterile / Non-Sterile / Measuring / Reusable
Document ID : TD-08
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Software Medical Device with or without Measuring Function
Document ID : TD-09
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Class IIb Technical File Templates
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Active Device - Sterile / Non-Sterile / Measuring / Reusable with/without Software
Document ID : TD-10
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Non-Active Device - Sterile / Non-Sterile / Measuring / Reusable
Document ID : TD-11
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Non-Active Device - Implant - Sterile / Nonsterile / Measuring / Reusable
Document ID : TD-12
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Software Medical Device with or without Measuring Function
Document ID : TD-13
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Class III Technical File Templates
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Active Device - Sterile / Non-Sterile / Measuring / Reusable with/without Software
Document ID : TD-14
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Non-Active Device - Sterile / Non-Sterile / Measuring / Reusable
Document ID : TD-15
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Non-Active Device – Implant - Sterile / Non-Sterile / Measuring / Reusable
Document ID : TD-16
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Active Device - Implant - Sterile / Non-Sterile / Measuring / Reusable / with or without Software
Document ID : TD-17
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Software with or without Measuring Function
Document ID : TD-18
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Special Rule Technical File Templates
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Class III Devices Incorporate Medicinal Product under Rule 14
Document ID : TD-19
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Class IIa/IIb Devices for Contraception under Rule 15
Document ID : TD-20
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Class IIa/IIb Devices used for Disinfecting, Cleaning or Sterilizing Medical Device under Rule 16
Document ID : TD-21
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Class III Devices made using tissues or cells of human or Animal Origin, or their derivatives under Rule 18
Document ID : TD-22
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Class IIa/ IIb/III Nanomaterials under Rule 19
Document ID : TD-23
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Class IIa/IIb Devices for Medicinal Inhalation under Rule 20
Document ID : TD-24
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Class IIa/IIb/III Devices composed of substances that are absorbed or locally dispersed under Rule 21
Document ID : TD-25
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