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Legislative History

Title: Regulations Governing the Classification of Medical Devices CH
Announced Date: 2021-04-26
Amended Date: 2023-08-22
Category: Ministry of Health and Welfare(衛生福利部)
Attachment:
1.Full text including 7 articles adopted and promulgated by the Ministry of Health and Welfare per Order Bu-Shou-Shi-Zi No. 1101603189 on April 26, 2021. These Regulations shall enter into force take effect on May 1, 2021, excluding classification numbers “A.3652”, “C.3372”, and “C.3970” from the Annex which shall be effective on July 1, 2022.
2.Appendix amended by Ministry of Health and per Welfare Order Bu-Shou-Shi-Zi No. 1101613379, on December 9, 2021.
3.Text of Article 7, Annex to Article 4 amended by Ministry of Health and per Welfare Order Bu-Shou-Shi-Zi No. 1121606224, The amendments to the Annex to Article 4 shall enter into force on August 22, 2023, excluding classification numbers “D.1100”, “J.5780”, and “M.5844” from the Annex which shall be effective on August 22, 2025 and classification number “I.4040” from the Annex which shall be effective on August 22, 2026.