Is it a medical device? - National Drug Authority

NDA considers a product to be a medical device, and subject to NDA regulation, if it meets the definition of a medical device below;

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

diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, 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 in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its intended function by such means

Examples of medical devices may include; gauze roll, absorbent cotton, ventilators, incubators ,syringes, BP machines, condoms, gloves ,catheters, diagnostic kits,

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Annual Pharmacovigilance Report 2023/2024