National Health Regulatory Authority (NHRA) regulates medical devices in Bahrain.
Medical Device Definition
A medical device in Bahrain means 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:
The device must not use pharmacological, immunological, or metabolic means to perform its primary function, although it may be assisted by such means.
- 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.
Medical Device Classification System
||Bandages and elastic bandages
||low to Moderate risk
||Blood glucose monitors and manual wheelchairs
||Moderate to High risk
||Computerized tomography (CT) scanners and electric wheelchairs
||Implantable pacemakers and artificial heart valves
||2 to 4 months approx.
|License validity period
||Class I :- $398, Class IIa, IIb :- $796, Class III:- $2653