Article 3 The medical devices referred to in these regulations refers to the use of the human body individually or in combination with the instruments, equipment, appliances, materials, or other items, including the required software; its use for the human body surface and the body's role is not by means of Pharmacology, immunology or metabolic means of obtaining, but may have these means of participation and play a certain role in supporting; its use is intended to achieve the following purposes:
(a) the prevention, diagnosis, treatment, monitoring, alleviation of disease;
(b) diagnosis, treatment, monitoring, alleviation of injuries or disabilities, compensation;
(c) anatomical or physiological processes, research, replacement, adjustment, or compensation. physiological processes;
(iv) the study, substitution, regulation;
(v) pregnancy control.
It is sufficient to demonstrate that the intended use of the spectrophotometer is none of these.