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:

1. Diagnosis, prevention, monitoring, treatment, or alleviation of disease,
2. Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury,
3. Investigation, replacement, modification, or support of the anatomy or of a physiological process,
4. Supporting or sustaining life,
5. Control of conception,
6. Disinfection of medical devices,
7. 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	- Appoint a Bahraini-authorized representative (AR). - Classification criteria must be fulfilled (If applicable) before submitting for registration. - After submitting the listing form, a medical device registration application can be submitted. - Submit all required documents through the Ajheza system website: https://ajheza.nhra.bh/user-login - Review process timeframe is 20 working days. - For fast-track application submissions, NHRA has recognized ABC company as a conformity assessment body: https://www.nhra.bh/Administrator/login.aspxReturnUrl=%2fAdministrator%2fSecured%2fMediaHandler%2fGenericHandler%2fdocuments%2fdepartments%2fMDR%2fCirculars%2fMDR_3.PDF - The timeframe for the registration file through fast-track review is 10 working days. - Fees will be applied, and notice to pay will be sent to applicants via the Ajheza system. - Pay the requested fees - If all requirements are fulfilled, a registration certificate will be issued with a validity of 1 year.
Class IIa
Class IIb
Class III