Taiwan medical device regulations
Official sources linkedTFDA rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
30 documents7 categories100% linked to official sourcesauthority TFDA24 readable HTML
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| Medical Devices Act | Medical Devices Act Controlling Chinese text from the Ministry of Justice Laws Database (pcode L0030106), with the authority English translation ingested separately. Promulgated 15 January 2020 (ROC 109-01-15); Executive Yuan set the effective date as 1 May 2021. 85 articles. | General | May 1, 2021 | Official |
| 醫療器材行政規費收費標準 | Standards for Medical Device Administrative Fees Authorized subordinate pcode L0030123, announced 23 February 2023. 4 articles. The Ministry of Justice English translation page returns empty bytes, so only the Chinese controlling text is ingested. Distinct from the shared food/drug/cosmetics laboratory-fee schedule L0040094, which was not ingested. | General | — | Official |
| Regulations Governing Border Inspection and Examination of Imported Medical Devices | Regulations Governing Border Inspection and Examination of Imported Medical Devices Authorized subordinate pcode L0030122, last amended 31 March 2025. 19 articles. Chinese controlling text plus authority English translation. | Registration | — | Official |
| Classification System | Application for the Classification of Medical Devices TFDA classification-application portal. The exact classification instrument is tw-classification-regulations (L0030120). | Classification | — | Official |
| L0030120 Annex | Medical Device Classification Items — Official Annex Official English Annex to Article 4 of the classification regulations: 1,812 medical-device classification numbers with authority product name, Class 1–3, and identification text. The parent regulation remains tw-classification-regulations. | Classification | — | Official |
| Regulations Governing the Classification of Medical Devices | Regulations Governing the Classification of Medical Devices Authorized subordinate regulation pcode L0030120. Chinese controlling text plus authority English translation. Distinct from the TFDA classification-application portal. | Classification | — | Official |
| Regulations Governing Contract Manufacturing of Medical Devices | Regulations Governing Contract Manufacturing of Medical Devices Authorized subordinate pcode L0030117, announced 15 April 2021. 10 articles. Chinese controlling text plus authority English translation. | GMP/QMS | — | Official |
| E-Submission System | TFDA Medical Device Premarket E-Submission System E-submission platform announcement, not a legal instrument. Not ingested. | Registration | — | Official |
| Enforcement Rules of the Medical Devices Act | Enforcement Rules of the Medical Devices Act Authorized subordinate regulation pcode L0030121, announced 26 April 2021. Chinese controlling text plus authority English translation. | General | — | Official |
| Regulations Governing Commission of Medical Devices Management and Accreditation of Commissioned Institution | Regulations Governing Commission of Medical Device Management Matters Authorized subordinate pcode L0030129, announced 29 April 2021. 23 articles. Chinese controlling text plus authority English translation. | General | — | Official |
| Regulations on Good Clinical Practice for Medical Devices | Regulations on Good Clinical Practice for Medical Devices Authorized subordinate pcode L0030114, announced 9 April 2021. 72 articles. Chinese controlling text plus authority English translation. | Clinical Trials | — | Official |
| Regulations of Medical Device Good Distribution Practice | Regulations of Medical Device Good Distribution Practice Authorized subordinate pcode L0030115, announced 13 April 2021. 30 articles. Chinese controlling text plus authority English translation. | GMP/QMS | — | Official |
| Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License | Regulations for GDP Inspection and Distribution Licence Issuance Authorized subordinate pcode L0030111, announced 29 January 2021. 12 articles. Chinese controlling text plus authority English translation. | GMP/QMS | — | Official |
| Regulations Governing Incentive Rewards for Research and Development of Innovative Medical Devices Technology | Regulations Governing Incentive Rewards for Innovative Medical Device R&D Authorized subordinate pcode L0030130, announced 29 April 2021. 8 articles. Chinese controlling text plus authority English translation. | General | — | Official |
| Regulations Governing Designation or Commission of Medical Devices Test | Regulations Governing Designation or Commission of Medical Devices Test Authorized subordinate pcode L0030131, announced 30 April 2021. 9 articles. Chinese controlling text plus authority English translation. | General | — | Official |
| Regulations Governing Accreditation and Outsourced Accreditation Management of Medical Devices Institutions | Regulations Governing Accreditation of Medical Device Testing Institutions Authorized subordinate pcode L0030127, announced 29 April 2021. 32 articles. Chinese controlling text plus authority English translation. | General | — | Official |
| TFDA Law & Regulations | Medical Device Guidance, Law & Regulations Collection TFDA collection page. Exact subordinate instruments are identified on the Ministry of Justice authorized-subordinate list for L0030106, not on this portal. | General | — | Official |
| Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration | Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration Authorized subordinate pcode L0030128, last amended 27 November 2023. 27 numbered articles including official Article 13-1 in both Chinese and the authority English translation. | Registration | — | Official |
| 醫療器材製造業者設置標準 | Standards for Establishment of Medical Device Manufacturers Authorized subordinate pcode L0030110, announced 10 December 2020. 10 articles. The Ministry of Justice English translation page returns empty bytes, so only the Chinese controlling text is ingested. | GMP/QMS | — | Official |
| Medical Device Quality Management System Regulations | Medical Device Quality Management System Regulations Authorized subordinate pcode L0030116, announced 14 April 2021. 79 articles. Chinese controlling text plus authority English translation. Distinct from the TFDA QSD application portal. | GMP/QMS | — | Official |
| Regulations Governing the Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing license | Regulations Governing QMS Inspection and Manufacturing Licence Issuance Authorized subordinate pcode L0030112, announced 2 February 2021. 13 articles on QMS inspection and manufacturing-licence issuance. Chinese controlling text plus authority English translation. | GMP/QMS | — | Official |
| QSD Certification | Quality System Documentation (QSD) Application for Foreign Manufacturers TFDA QSD application portal. The exact QMS subordinate instrument is tw-qms (MOJ pcode L0030116); the inspection/licence instrument is tw-qms-inspection (L0030112). | GMP/QMS | — | Official |
| Regulations for Medical Device Recalls | Regulations for Medical Device Recalls Authorized subordinate pcode L0030126, announced 28 April 2021. 14 articles. Chinese controlling text plus authority English translation. | Vigilance | — | Official |
| Device Registration | Registration of Medical Devices TFDA registration overview page, not the Medical Devices Act. Not ingested. | Registration | — | Official |
| Regulations for Management of Medical Device Safety Surveillance | Regulations for Management of Medical Device Safety Surveillance Authorized subordinate pcode L0030125, announced 28 April 2021. 15 articles. Chinese controlling text plus authority English translation. | Vigilance | — | Official |
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Tracked from official TFDA publications · row IDs are stable — cite as regulations:taiwan:tw-admin-fees