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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