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Regulatory translation is the translation of documentation pertaining to the approval and compliance of medical devices, pharmaceuticals and ''in vitro'' diagnostics products. Many countries around the world, including Japan and the United States, require that approval dossiers for new products be submitted in local languages for the regulatory bodies to read and analyze. Similarly, any documentation associated with follow-up changes to approved products or reporting of field issues must be translated for countries that require it.〔Regulations for Medical Devices and the Role of Guidance Documents in Europe ()〕 Aside from linguistic skills, regulatory translation requires specific training and subject matter knowledge in order to translate medical and regulatory content. This is because of the highly technical, sensitive and regulated nature of medical texts as well as the strict adherence to terminology required for some countries. Regulatory translation also requires specific knowledge of the document templates required for different countries' dossier formats. Because approval dossiers are often composed of a variety of different document types, such as CAD drawings, spreadsheets, scanned patient signatures as well as word processed expository sections, the translation process can be more difficult than other types of medical translation. ==Examples of regulatory texts== Some examples〔(Regulatory translation )〕 of the types of regulatory documents requiring translation include (but are not limited to): * Manufacturing procedures for medical devices or drugs * Design specifications and drawings * Risk assessments * CMC documentation * Bio-compatibility reports * Regulatory approval dossiers * Clinical trial documentation – informed consent forms, case report forms, protocols * Instructions for Use for drugs or medical devices 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Regulatory translation」の詳細全文を読む スポンサード リンク
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