The term "medical devices", as used in this Act, shall refer to instruments, machines, apparatus, materials, software, reagents for in vitro use, and related articles thereof, whose design and use achieve one of the following primary intended actions in or on the human body by other than pharmacological, immunological, metabolic, or chemical means:
1. Diagnosis, treatment, alleviation, or direct prevention of human diseases.
2. Modification or improvement of the structure and function of human body.
3. Control of conception.
Regulations governing the categories, risk classification, items, determination principles, and other related matters shall be established by the central competent authority.
Assistive devices covered by Subparagraph 2 of Paragraph 1 that are non-invasive, not expected to cause harm to the health of human body, and used without the assistance of medical personnel may be notified to the central competent authority for approval and exempt from being listed as medical devices of the preceding paragraph.
Assistive devices set forth in the preceding paragraph refer to appliances, equipment, instruments, and software that assist physically or mentally disabled persons to improve or maintain physical function and structure, to facilitate activity and participation, or to provide convenience to the attendance of their caregivers.