Bahrain medical device regulatory resources

Competent authority: National Health Regulatory Authority (NHRA), Medical Devices & Supplies Control Section

The competent authority for medical devices and IVDs in the Kingdom of Bahrain is the National Health Regulatory Authority (NHRA), established by Law No. (38) of 2009 as amended by Decree L…

Legal basis: Resolution No. (48) of 2020 on medical devices and products' quality control, as amended by Resolution No. (69) of 2024

The governing instrument for medical devices and IVDs is Resolution No. (48) of 2020 on the control of the quality of medical devices and products, issued by the Chairman of the Supreme Cou…

Statutory definition of medical device and IVD

Resolution No. (48) of 2020 defines a medical device as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent, software, material or other similar or related a…

Bahrain classes I, IIa, IIb and III — four-band device axis

Class I — Low Risk Medical Device, Class IIa — Low to Medium risk device, Class IIb — Medium to High Risk Device, Class III — High Risk Device

Fast track through third-party services

Bahrain operates an ordinary route through the Ajheza/Madar electronic system and a paid fast track delivered through third party companies, with a shorter review clock (10 working days aga…

Two-step route: device listing first, then registration, both through a licensed authorized representative

Only a registered authorized representative can apply for medical device registration in Bahrain. All devices that have been imported or are intended to be imported must first be listed wit…

CE certificate under the medical-device directives/regulations or FDA Certificate to Foreign Government required as quality assurance certificate

statement: Registration of a medical device in Bahrain requires a Quality Assurance Certificate for the legal manufacturer, which is accepted in the form of a CE certificate under Directive…

Class III / Class D IVD requires an EC Design Examination certificate or FDA Certificate to Foreign Government

statement: For class III medical devices and class D IVDs, Bahrain requires an EC Design Examination certificate or an FDA Certificate to Foreign Government for the legal manufacturer; the…

Foreign manufacturers must act through a Bahraini licensed authorized representative

Manufacturers outside Bahrain cannot apply directly: only a facility registered with NHRA as a Medical Device Authorized Representative may apply, import and hold the registration. Resoluti…

Pre-approval of every shipment through the OFOQ customs system

Importation of medical devices into Bahrain requires NHRA pre approval granted through the OFOQ system operated by Customs Affairs. All medical devices under HS code ministry code 2251 must…

Registration dossier: unconditional and conditional document set

The Bahraini registration dossier has seven unconditional items technical details (IFU, leaflet or user manual), artwork/label, the manufacturer's authorization letter to the authorized rep…

No source-verified answer is published for this dimension yet.

Label language: Arabic or English

Bahraini labelling rules require the label text to be clear and in Arabic or English, so English only labelling is acceptable; Arabic is not mandatory. The label must carry the device name,…

ISO 13485 certificate for the physical manufacturer, with verification evidence

The unconditional documentation set for Bahraini registration requires a Quality Management System certificate to ISO 13485 for the physical manufacturer, whose address must match the relat…

NHRA Quality Assurance Certificate — CE marking or FDA Certificate to Foreign Government

Electrical safety

TRA type approval for telecommunications equipment

Wireless / radio

SCE approval to use ionizing radiation sources

Radiation

Application to submit a medical device registration

BHD 5

Medical Device & Supplies traceability fee

BHD 5

Medical device registration — standard NHRA review · Application filed by a registered Bahrain Authorized Representative: the device is listed with NHRA, an appointment is booked in the Ajheza system, and the full dossier is submitted at the appointment

20 working days

Medical device registration — fast track through third-party services · Registration application routed through a third-party service provider

10 working days

Product classification request — NHRA classification letter · Application for a classification letter, submitted with the free sale certificate or registration certificate from the country of origin or a reference country and a recognised quality assurance certificate

1-2 weeks

Marketing authorisation valid for three years under the 2024 amendment

Resolution No. (69) of 2024 replaced the first two paragraphs of Article (10) of Resolution No. (48) of 2020 so that, except for low risk home use devices, no person may market or advertise…

Minor variation approval; major variation requires a new registration application

Bahrain distinguishes minor variations, which do not affect safety or performance (renewal of any certificate or official letter, artwork or label changes, IFU changes, authorized represent…

Authorized representative must list all devices before applying for registration

Every registered authorized representative must list all medical devices that have been imported or are intended to be imported in the future. Only listed medical devices can be applied for…

Statutory electronic registration system recording device identification, origin and shelf life

The Authority establishes an electronic system for the registration of medical devices and products and of the facilities dealing in them, in which all data relating to the device and the e…

Current NHRA checklist: 16 documents for Phase II–III (all) and Phase IV (subset), including protocol, IB, ICF/CRF, insurance, investigator licences, IMPD/CMC, product labelling, GMP certificate, CRO authorisation, IREC approval and clinical trial agreement

The 2024 checklist requires for Phase II–III: cover letter, application form, signed dated protocol, Investigator's Brochure, sample ICF and CRF, clinical trial insurance policy with corpor…

Every research involving humans needs IREC/NHRA ECPH ethics approval from each institution before any trial activity, and Phase II–III trials need an NHRA authorisation applied for at the NHRA CEO's office

All research involving human beings must be reviewed by an Institutional Independent Research Ethics Committee (IREC) or, for private hospitals, the NHRA Ethics Committee for Private Hospit…

Cases exempt from medical device registration

Circular No. (1) of 2022, issued under Resolution No. (48) of 2020, exempts from registration: devices imported for a healthcare facility for an emergency or on a single occasion and not pl…

NHRA recommends a PMS officer; its authorized-representative guideline includes the assignment as a general rule

NHRA Circular No. (18) of 2022 (12 May 2022), issued with reference to Article (4) of Resolution No. (48) of 2020, states that it is 'strictly recommended' that all healthcare facilities an…

Adverse event reporting: 10 working days for death or serious injury, 30 working days otherwise

Adverse events associated with a medical device are reported to NHRA on the Medical Devices Reporting form. Death or serious injury must be reported within 10 working days and other problem…

Field safety notice must reach NHRA in 2, 5 or 10 working days by risk level

When a field safety notice affects the Bahraini market, the authorized representative must provide a copy of the notice to NHRA within 2 working days for very high risk notices, 5 working d…

Prior authorisation required to market or advertise a medical device

Under Article (10) of Resolution No. (48) of 2020 as amended by Resolution No. (69) of 2024, except for low risk home use medical devices, no person may market or advertise a medical device…

Two further submission attempts without repaying the fee; 10 working days to appeal a rejection

If a Bahraini registration application does not fulfil all requirements it is returned with the recommended action; the applicant has two further submission attempts without repaying the ap…