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Legislative History
Legislative History
Title:
Regulations for Management of Medical Device Safety Surveillance
CH
Announced Date:
2021-04-28
Category:
Ministry of Health and Welfare(衛生福利部)
Attachment:
Appendix 1 Items that shall be indicated in the Medical Device Safety Surveillance Plan.pdf
Appendix 2 Medical Device Periodic Safety Report.pdf
Appendix 3 Medical Device Safety Summary Report.pdf
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Legislative History
1.Full text including 15 articles adopted and promulgated by the Ministry of Health and Welfare per Order Bu-Shou-Shi-Zi No. 1101603002 on April 28, 2021. These Regulations shall enter into force take effect on May 1, 2021.