醫療器材查驗登記 (Device Registration)

收費項目 (Application Type)  和 每件審查費用(Fee/Per Application)

全球首創無類似品 (Device with no similar device in other countries) 

NT$250,000

優先審查(Priority Review Program) 

NT$180,000               

新原理、新結構、新材料、新效能或無類似品 (Device with a new mechanism, new structure, new material, new function, or no similar predicate)

NT$130,000

第三等級醫療器材 (Class III Device Registration)

NT$100,000

第二等級醫療器材 (Class II Device Registration)

NT$58,000            

第一等級醫療器材 (Class II Device Registration)

NT$15,000   

專供外銷醫療器材 (Device registration only for exportation)

NT$15,000                

許可證登記事項變更及展延 (The Post-Approval Change and Extension)

收費項目 (Application Type)  和 每件審查費用(Fee/Per Application)

效能、用途或適應症變更 (Change in indication for use or intended use) 

NT$40,000     

變更規格 (Change in specification)

NT$35,000                                                        

未涉及安全及效能評估之尺寸規格變更 (Change in specification without involving safety and effectiveness evaluation)

NT$25,000

移轉、合併、產地或遷廠變更 (Change in transfer, merger, place of production or manufacturing-site relocation)

NT$25,000

其他變更 (Other changes)

NT$10,000

許可證之標籤或說明書核定本補發 (Reissue of a license, approved label or package insert)

NT$10,000

原核准許可證有效期間展延 (Extension of a medical device license)

NT$8,000

許可證領證、補發或換發 (Initial issuance, reissuance and replacement of medical device license)

NT$1,500

登錄、年度申報及登錄事項變更 (Listing, Annual Declaration and Changes to Registration)

收費項目 (Application Type)  和 每件審查費用(Fee/Per Application)

醫療器材登錄 (Listing of medical device)

NT$10,000

醫療器材年度申報 (Annual declaration of medical device)

NT$2,000

醫療器材登錄之變更 (Changes to medical device registration)

NT$8,000

臨床試驗 (Clinical Trial)

收費項目 (Application Type)  和 每件審查費用(Fee/Per Application)

臨床試驗計畫書審核 (Review of a medical device clinical trial protocol)

NT$50,000

臨床試驗報告書審查 (Inspection of a medical device clinical report)

NT$50,000

臨床試驗文件技術性評估 (Evaluation of a medical device clinical trial technical documentation)

NT$20,000

臨床試驗變更審查 (Review of change(s) to a medical device clinical trial)

NT$5,000

國外優良臨床試驗實地查核(每次每一國家(地區)) (Good clinical practice for foreign on-site inspection for each country/one time)

NT$650,000

國內優良臨床試驗實地查核 (Good clinical practice for domestic on-site inspection)

NT$45,000

品質管理系統檢查 (Quality Management System, QMS)

收費項目 (Application Type)  和 每件審查費用(Fee/Per Application)

國內醫療器材品質管理系統檢查及其後續管理檢查 (Domestic medical device QMS inspection and follow-up inspection)

NT$60,000

國外醫療器材品質管理系統文件檢查或其後續檢查 (Foreign medical device QMS documentation review or follow-up review)

NT$60,000

醫療器材製造許可增加登錄品項、內容或遷廠之變更 (Inspection for addition of new product item(s), contents, or site relocation of a medical device manufacturer)

NT$60,000

醫療器材製造許可之其他變更 (Other changes of a medical device manufacturing license)

NT$10,000

*國外醫療器材品質管理系統實地檢查或其後續檢查 (Initial or follow-up on-site inspection of a foreign medical device manufacturer)

NT$600,000

*國外醫療器材製造許可增加登錄品項、內容之實地檢查 (On-site inspection for addition of new product item(s), contents of a foreign medical device manufacturer)

NT$600,000

*國外醫療器材製造許可遷廠之實地檢查 (On-site inspection for site relocation of a foreign medical device manufacturer)

NT$600,000

前三目收費項目，每件每增加一醫療器材品項製程，增加收費如下

(Additional fees will be charged as below for each additional medical device item which is marked *)

同一廠房 (In the same premises)

NT$35,000

不同廠房  (In different premises)

NT$105,000

國外醫療器材品質管理系統實地檢查 (每件每增加一不同滅菌製程) (An additional fee will be charged for each additional sterilisation process)

NT$105,000

國外醫療器材品質管理系統實地檢查 (每件每增加一委外製造廠) (An additional fee will be charged when there is an additional outsourcing process)

NT$300,000

醫療器材製造業者符合醫療器材品質管理系統準則第七十八條規定之檢查或其後續檢查 (Initial or follow-up inspection of a medical device manufacturer who complies with Article 78 of the QMS)

NT$30,000

優良運銷系統檢查或其後續檢查 (Good Distribution Practice (GDP) inspection or follow-up inspection)

NT$30,000

醫療器材運銷許可登記事項之變更 (Changes to the registration items of a medical device distribution license)

 NT$10,000

相關文件申請 (Other Applications)

收費項目 (Application Type) 和 每件審查費用(Fee/Per Application)

屬性管理查詢 (Consultation on the regulatory classification and applicable regulations of a medical device)

NT$3,500

自用原料申請 (Application of medical device raw material for manufacturer's own use)

NT$6,000

許可證授權申請案 (Application for authorisation for import or export of drugs and medical devices)

NT$4,000

中文、英文製（銷）售證明書 (每件以一式三份為限;每件以一許可證為限) (Free Manufacturing/Sale Certificate in Chinese or English (Three copies of the certificate per application and one license is limited))

NT$1,800

中文、英文製造許可證明文件及其補發 (每件以一式三份為限) (QMS certificate in Chinese or English and its reissue (Three copies of the certificate per application))

NT$1,800

優良運銷證明文件及其補發 (GDP certification and its reissue)

NT$1,800

委託製造申請 (Outsourcing manufacturing application)

NT$4,000

委託製造變更申請 (Change of outsourcing manufacturing application)

NT$2,000

專案申請 (Special Approval for Manufacture or Import of Specific Medical Devices)

收費項目 (Application Type)  和 每件審查費用(Fee/Per Application)

改進製造、研究、試驗、危急重大或嚴重失能、展示 (For the purpose of improving manufacture, study, investigation, preventing, diagnosing, or treating life-threatening or severe disability diseases, display)

NT$10,000

因應緊急公共衛生情事製造或輸入 (The necessity of responding to emergency public health circumstances)

NT$20,000

個人自用 (For personal use)

NT$2,000

國貨復運 (Re-import of devices)

NT$12,000

廣告審查 (Medical Device Advertisements)

收費項目 (Application Type)  和 每件審查費用(Fee/Per Application)

新申請 (New Application)

NT$10,000

展延申請 (Extension Application)

NT$5,000

核定表遺失補發 (Reissue of approved advertisement form)

NT$2,500

案件函詢 (Letter of Inquiry)

收費項目 (Application Type)  和 每件審查費用(Fee/Per Application)

函詢醫療器材查驗登記、登錄、臨床試驗、製造品質檢查及運銷管理 (Inquiry about medical device registration, listing, clinical trials, QMS and GDP)

NT$4,000

函詢全國醫療器材不良反應通報資料庫資料 (Inquiry about retrieving data from the national adverse drug/device reaction database)

NT$4,000