All medical devices are regulated by the Pharmaceutical Product Regulatory Office (PPRO) of the National Health Regulatory Authority (NHRA).
Medical Device Definition
Means all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability that does not achieve its action by pharmacological, immunological or metabolic means.
Classification of Medical Device
|International Classification||Examples||Risk Level|
|B||Urine test strips||Low - Moderate|
|C||Blood Glucose self-testing||High - Moderate|
|D||HIV blood analyzer||High|
|Postmarket Surveillance ||Some controls in place.|
|Timeline||Approximately two months.|