The Medical Devices and Supplies Control Section at the National Health Regulatory Authority (NHRA) regulates medical devices and supplies throughout their lifecycle in the Kingdom of Bahrain.

The Section’s work covers pre-market activities, on-market and importation controls, and post-market surveillance. Through these activities, NHRA aims to ensure that medical devices meet the applicable requirements for quality, safety and performance, while providing clear regulatory pathways for establishments, products and related services.

Our Role and Services

Pre-Market Regulation and Establishment Oversight

Before a medical device is placed on the Bahrain market, the Section provides the following regulatory services:

-Registration and licensing of Medical Device Authorized Representatives, including new, variation and renewal applications, with an expedited route where available.

-Registration and licensing of Medical Device Storing Facilities, including new, variation and renewal applications.

-Registration and licensing of Local Medical Device Manufacturing Facilities, including new, variation and renewal applications.

-Review of requests to update the registered information of medical device establishments and requests for facility re-inspection.

-Classification of medical devices through standard, reliance and expedited routes, as applicable, including the classification of salon devices and the issuance of medical -device classification certificates.

-Registration of medical devices, including new, variation and renewal applications through standard, reliance and expedited routes, as applicable.

-Review of requests to update registered medical device information.

-Issuance of regulatory certificates and documents related to medical device manufacturers and products, including Free Sale Certificates and other official documents.

On-Market and Importation

The Section supports the regulatory control of medical devices entering the Kingdom of Bahrain through the following services:

-Review of medical device importation pre-approval applications submitted through the OFOQ system in coordination with Customs Affairs and based on the applicable HS codes. This includes registered and unregistered medical devices, in vitro diagnostic medical devices and combined medical devices.

-Verification of Quality Assurance Certificates and other relevant regulatory documents, where applicable.

-Examination of medical device samples when required as part of the importation review process.

-Inspection of medical device shipments at ports when further verification is required.

Post-Market Surveillance and Control

After medical devices are placed on the Bahrain market, the Section continues to monitor their safety, use and regulatory compliance through:

-Review of Permission to Use applications, including the evaluation of the suitability of medical devices for their intended use.

-Receiving and reviewing complaints, adverse events and incidents associated with medical devices.

-Reviewing Field Safety Notices, safety alerts, recalls and related corrective actions.

-Supervising the disposal and destruction of medical devices.

-Overseeing medical device and supplies traceability requirements.

These activities help identify and manage safety concerns, support appropriate corrective actions and reduce the risk of unsafe or non-compliant medical devices remaining in use.

Vision

To establish a trusted and internationally aligned regulatory system that ensures the safety, quality and performance of medical devices in the Kingdom of Bahrain and contributes to the protection of public health.

Mission

To protect patients, users and healthcare professionals by regulating medical device establishments, products, importation activities and post-market operations through effective assessment, transparent regulatory processes, continuous surveillance and collaboration with relevant stakeholders.

Our Commitment