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Q：
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What is the definition of “medical equipment”?
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A：
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Medical equipment refers to equipment that diagnoses, treats, alleviates, directly prevents human disease, regulates fertility, or is sufficient to affect the structure and function of the human body, and does not act on the human body through pharmacological, immune or metabolic methods to achieve its main function. Devices, utensils, substances, software, in vitro reagents and related items.
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Q：
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What are the classification levels of medical equipment?
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A：
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Medical equipment is divided into first, second and third levels according to the level of risk. The higher the risk, the higher the level; the higher the level, please refer to the “Regulations for Governing Classification of Medical Device” for detailed classification.
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Q：
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What is the competent authority for applying for a medical device dealer license?
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A：
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The competent authority for application is the Food and Drug Administration of the Ministry of Health and Welfare.
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Q：
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What applications must be completed before applying for a medical equipment license?
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A：
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Before applying for a medical equipment license, you must first obtain a medical equipment pre-approval license.
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Q：
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What are the qualifications of technical personnel required for medical equipment license application?
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A：
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Due to the different classifications of medical equipment, the requirements are different. For detailed technical personnel requirements and qualifications, please refer to the “Regulations for Governing Classification of Medical Device”.
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FAQ
