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Bahrain Medical Device Regulations

Agency
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:
  • 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.
The device must not use pharmacological, immunological, or metabolic means to perform its primary function, although it may be assisted by such means.
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
Approval Process
Classification Approval procedure
Class I
  • Appoint a local authorized representative in Bahrain.
  • The applicant must apply for valid commercial registration.
  • Apply for registration with the required supporting documents.
  • If approved, device registration will be granted.
Class IIa
Class IIb
Class III
Additional Information
Approval timeline 2 to 4 months approx.
License validity period 1 year
Fees Class I :- $398, Class IIa, IIb :- $796, Class III:- $2653
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