Bahrain Medical Device Regulations
Regulatory Agency
National Health Regulatory Authority (NHRA) regulates medical devices in Bahrain.
Medical Device Definition
Medical Device: 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, 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 may be assisted in its intended function by such means.
Low-Risk Home Medical Devices and Products: these are medical devices and supplies that are used outside of a healthcare setting, do not require complex maintenance, and do not require a prescription, such as digital thermometers and blood pressure monitors.
Medical Device Classification System
| International Classification | Risk Level | Examples |
|---|---|---|
| Class I | Low risk | Bandages and elastic bandages |
| Class IIa | low to Moderate risk | Blood glucose monitors and manual wheelchairs |
| Class IIb | Moderate to High risk | Computerized tomography (CT) scanners and electric wheelchairs |
| Class III | High risk | Implantable pacemakers and artificial heart valves |
Regulatory Approval Process
Classification |
Approval procedure |
|---|---|
Class I
Class IIa
Class IIb
Class III |
|
Additional Information
Approval timeline |
20 working days |
License validity period |
1 year |
Fees |
Class I :- $398, Class IIa, IIb :- $797, Class III:- $2659 |
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