Legal analysis: According to the relevant provisions of the medical device registrant, the filer refers to the acquisition of medical device registration certificate or for the record of the medical device enterprises or development institutions.
Legal basis: Article 103 of the Regulations for the Supervision and Administration of Medical Devices The meaning of the following terms in these regulations:
Medical device means an instrument, 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; the utility of which is obtained mainly through physical and other means. not by pharmacological, immunological, or metabolic means, or which, although involved in these means, play only an ancillary role; and which are intended to:
(i) diagnose, prevent, monitor, treat, or mitigate disease;
(ii) diagnose, monitor, treat, mitigate, or functionally compensate for injury;
(iii) test physiological structures or processes, replacement, regulation, or support;
(iv) life support or maintenance;
(v) pregnancy control;
(vi) providing information for medical or diagnostic purposes through the examination of samples from the human body.
Medical device registrant, filer, refers to the acquisition of a medical device registration certificate or for the record of medical devices, the enterprise or development organization.