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Kaohsiung City Health Bureau forwards the Ministry of Health and Welfare’s “Standard Operating Procedure for Review of Human Trials of New Medical Technologies”

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1. Processed by the Kaohsiung City Government Health Bureau, letter No. 11043782500 dated December 20, 2021.

2. According to Articles 2 and 3 of the “Regulations on Human Subject Research,” it is stipulated: “Before a medical institution incorporates a new medical technology into routine medical procedures, it must conduct human subject research and draft a plan to apply for approval from the central competent authority.”

3. The relevant procedural steps can be consulted on the Ministry of Health and Welfare website (path: Home / All units and subordinate agencies of the Ministry / Department of Medical Affairs / Biomedical Technology and Organ Transplantation / Human Research (Trials) related).