Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including the required computer software; their utility is obtained mainly by physical and other means, not by pharmacological, immunological or metabolic means, or although these modalities are involved but only in an ancillary manner; and which are intended for:
(i) the diagnosis, prevention, monitoring, treatment, or mitigation of disease;
(ii) the diagnosis, monitoring, treatment, mitigation, or functional compensation of injuries;
(iii) the testing, substitution, modulation, or support of physiological structures or processes;
(iv) the support of life or maintenance;
(v) pregnancy control;
(vi) providing information for medical or diagnostic purposes through the examination of samples from the human body.
Medical device use units are institutions that use medical devices to provide medical and other technical services to others, including medical institutions that have obtained a license to practice as a medical institution, family planning technical service institutions that have obtained a license to practice as a family planning technical service institution, as well as blood stations, mono-collecting plasma stations, and rehabilitation aids fitting institutions that are not required by law to obtain a license to practice as a medical institution.
Surgical microscopes are classified as Class II medical devices,
Does the transmission electron microscope meet the standards for medical devices?
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