Occupational Safety and Health Act Article 8

(Ⅰ)Machinery, equipment, or tools announced by the Central Competent Authority as requiring type certification shall not be manufactured and shipped from the factory nor imported by manufactures or importers if their qualification label or type certification is not issued by a certification body authorized by the Central Competent Authority.(Ⅱ)If machinery, equipment or tools specified in the preceding paragraph satisfies any one of the following circumstances, certification may be waived and is not subject to the limits set in the preceding paragraph:1.Those that have undergone inspections, examination, certification, or approval in accordance with Article 16 or other legal regulations.2.Those that are provided for military or national defense use, with documentation to this effect issued by the Ministry of National Defense or a subordinate body thereof.3.Those that are special model manufactured or imported in limited quantities for the sole purpose of technological research and development or testing, and have been authorized by the Central Competent Authority.4.Those that are used for commercial sample or exhibition and not for actual use or operation purpose, and have been authorized by the Central Competent Authority.5.Other special circumstances requiring that certification be waived, and approved by the Central Competent Authority.(Ⅲ)For the certification referred to in Paragraph 1, where unusual structural specifications of products leading to difficulties in certification, the obligatory applicants may attach the product safety assessment reports and request with the Central Competent Authority for the approval of a suitable means of examination.(Ⅳ)For the certification referred to in Paragraph 1, due to the requirements of certification, importers may apply to the Central Competent Authority for prior releases. With approval such certification is allowed to be conducted at location where the products are installed.(Ⅴ)The implementation processes, items, standards, obligatory applicants for type certifications, the qualifications, their approval and the revocation and cancellation thereof, qualification mark, labeling methods, the conditions for prior release, request for certification waiver, safety assessment reports, overseeing and supervision, and other binding matters specified in the preceding four paragraphs shall be stipulated by the Central Competent Authority.
中文原文 職業安全衛生法第8條
製造者或輸入者對於中央主管機關公告列入型式驗證之機械、設備或器具,非經中央主管機關認可之驗證機構實施型式驗證合格及張貼合格標章,不得產製運出廠場或輸入。
前項應實施型式驗證之機械、設備或器具,有下列情形之一者,得免驗證,不受前項規定之限制:
一、依第十六條或其他法律規定實施檢查、檢驗、驗證或認可。
二、供國防軍事用途使用,並有國防部或其直屬機關出具證明。
三、限量製造或輸入僅供科技研發、測試用途之專用機型,並經中央主管機關核准。
四、非供實際使用或作業用途之商業樣品或展覽品,並經中央主管機關核准。
五、其他特殊情形,有免驗證之必要,並經中央主管機關核准。
第一項之驗證,因產品構造規格特殊致驗證有困難者,報驗義務人得檢附產品安全評估報告,向中央主管機關申請核准採用適當檢驗方式為之。
輸入者對於第一項之驗證,因驗證之需求,得向中央主管機關申請先行放行,經核准後,於產品之設置地點實施驗證。
前四項之型式驗證實施程序、項目、標準、報驗義務人、驗證機構資格條件、認可、撤銷與廢止、合格標章、標示方法、先行放行條件、申請免驗、安全評估報告、監督管理及其他應遵行事項之辦法,由中央主管機關定之。

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