Nigeria Medical Device Regulations

A medical device in Nigeria is any instrument, apparatus, implement, machine, appliance, implant, reagent for in-vitro use, software, material, or another similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:

• diagnosis, prevention, monitoring, treatment, or alleviation of disease;
• diagnosis, monitoring, treatment, and alleviation of or compensation for an injury;
• investigation, replacement, modification, or support of the anatomy or of a physiological process;
• supporting or sustaining life;
• control of conception;
• disinfection of medical devices;
• providing information  by means of an in-vitro examination of specimens derived from the human body;

And which does not achieve its primary intended action by pharmacological, immunological, or metabolic means in or on the human body but may be assisted in its intended function by such means.