Medical Device Definition
"Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease,
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
- Investigation, replacement or modification of the anatomy or of a physiological process
- Control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means
Classification of Medical Device
||Urine test strips
||Low - Moderate
||Blood Glucose self-testing
||High - Moderate
||HIV blood analyzer
||Implementation of post market surveillance systems, adverse incident reporting
programs and vigilance activities is required.
||Class III Devices: Approx. 6-9 months. All other devices: Approx. 3-6 months.