Regulations Governing the Implementation and Monitoring of Type Certification for Mechanical Products Article 6

The obligatory applicant shall apply to certification bodies for type certification by completing an application form and providing the following documents:1.Declaration of Conformity: the declaration that the manufacturer or importer signs to declare conformity of the products to the implementation procedures and standards for type certification.2.Basic information about the products:(1)description of the product type, including product catalog, product name, illustration of the appearance, product classification code (HS code or CCC code), specifications of the main processing unit and control unit, etc.,(2)reasons for products being classified as the same type,(3)list of the main type and series of the type,(4)drawings of the construction, including illustration of the location of the product safety devices and their functions,(5)drawings of the electric, hydraulic or pneumatic circuit, if applicable,(6)instructions of performance,(7)instructions of the installation, operation, maintenance and repair of the product, as well as recommended practices for responding to hazards,(8)list of product safety devices and safety accessories, including the names, specifications, safety performance and compliance status, test reports of critical components and related strength calculations of the devices, and(9)other technical files required by the central competent authority.3.Registration documents: factory registration, company registration, business registration or other equivalent documents that demonstrate official approval for establishment, except where registration is not required by laws or relevant information has been registered with no changes.4.Conformity assessment certificates: conformity assessment certificates issued in accordance with the implementation procedures and standards for type certification. Where approval is obtained from the central competent authority, other certification documents may be used as alternatives to the conformity assessment certificates.The certification body may notify the obligatory applicant to supply documents within a certain time limit if the application documents do not comply with the requirements. The application shall be denied if the documents are not supplied within the specified time limit.The certification body may request the obligatory applicant to provide electronic files for related documents mentioned in subparagraph 1 for purpose of digital storage and management.Where the documents mentioned in subparagraph 1 are provided in copies, the obligatory applicant shall note on the copies that they are identical to the originals and properly signed. The certification body may request that the originals of the documents be provided for check, if necessary.
中文原文 機械類產品型式驗證實施及監督管理辦法第6條
報驗義務人申請產品型式驗證時,應填具申請書,並檢附載明下列事項書件,向驗證機構提出:
一、符合性聲明書:製造者或輸入者簽署該產品符合型式驗證之實施程序及標準之聲明書。
二、產品基本資料:
(一)型式名稱說明書:包括產品之型錄、名稱、外觀圖、商品分類號列、主機台及控制台基本規格等說明資訊。
(二)歸類為同一型式之理由說明書。
(三)主型式及系列型式清單。
(四)構造圖說,包括產品安全裝置之性能示意圖及安裝位置。
(五)有電氣、氣壓或液壓回路者,其各該相關回路圖。
(六)性能說明書。
(七)產品之安裝、操作、保養、維修說明書及危險對策。
(八)產品安全裝置及安全配備清單:包括相關裝置之品名、規格、安全性能與符合性說明、重要零組件驗證測試報告及相關強度計算。
(九)其他中央主管機關認有必要之技術文件資料。
三、設立登記文件:工廠登記、公司登記、商業登記或其他相當於設立登記之證明文件影本。
但依法無須設立登記或相關資料已於中央主管機關指定之資訊網站登錄有案,且其記載事項無變更者,不在此限。
四、符合性評鑑證明文件:依型式驗證之實施程序及標準核發之符合性評鑑合格文件。
但取得其他驗證證明文件報經中央主管機關同意者,得以該驗證證明文件替代符合性評鑑證明。
前項申請書件未符規定者,驗證機構得通知報驗義務人限期補正,屆期未補正者,不予受理。
驗證機構為辦理第一項文件資料之數位保存及管理,得要求報驗義務人提供相關資料之電子檔。
報驗義務人提供之第一項所定文件為影本者,應註明與正本相符字樣並簽章,必要時,驗證機構得要求提出正本供查對。

English translation for reference only; the Chinese text prevails. Not legal advice.