Bahrain NHRA Ajheza Medical Device Registration: Resolution 48/2020 Guide

Quick answer

Bahrain requires mandatory registration of medical devices with the National Health Regulatory Authority (NHRA) before marketing, under Ministerial Resolution No. 48 of 2020 on quality control of medical devices and products. Only applicants registered as a medical device Authorized Representative (AR) may file. Before any registration application, you must list each device by emailing the listing form to medical_devices@nhra.bh. Registration is then submitted through the Ajheza appointment system (or NHRA's online e-service channels as published on nhra.bh), with fees set on bahrain.bh ranging from BD 5 per listing request to BD 150–1,000 for first registration by risk class. Standard review is 20 working days (10 days on fast track). Certificates are valid for one year and require annual renewal with updated documentation.

Who this applies to

This guide applies to:

• Foreign manufacturers exporting medical devices to the Kingdom of Bahrain
• Local Authorized Representatives (ARs) registered with NHRA's Medical Device Registration department
• Importers and distributors placing devices on the Bahrain market
• Regulatory affairs teams mapping GCC pathways—especially from Saudi SFDA, India CDSCO, or EU MDR frameworks to Bahrain's Resolution 48/2020 requirements

Scope covers medical devices and supplies that NHRA must review and register before they can be marketed. Emergency-use devices follow a separate NHRA list. If your product is a medical device under NHRA classification rules, assume registration is required unless NHRA publishes a specific exemption.

Regulatory framework: Resolution 48/2020 and NHRA

The National Health Regulatory Authority (NHRA) regulates medical devices through its Medical Devices & Supplies Control Section (MDR). The operative legal instrument is Ministerial Resolution No. 48 of 2020 regarding quality control of medical devices and products, cited on both nhra.bh and the Bahrain government services portal bahrain.bh.

NHRA publishes supporting guidance on its registration page, including:

Operating without a valid NHRA registration certificate before marketing creates enforcement risk under Resolution 48/2020 and NHRA's violations framework. Treat unregistered supply as a hard stop—not a post-market cleanup task.

Risk classification and fee schedule (bahrain.bh)

NHRA applies a risk-based classification aligned with international norms (Class I through Class III, consistent with EU-style stratification per NHRA classification guidance). Fees published on bahrain.bh (Government Services Catalogue, Medical device registration service) are:

Process time on bahrain.bh:

Fast-track review is available when submission goes through a recognized conformity assessment body as designated by NHRA (referenced in NHRA registration guidance). Budget both the BD 5 listing fee per device and the risk-tier registration fee before filing.

Authorized Representative (AR) prerequisite

NHRA's first registration rule is explicit: applicants must be registered as medical device Authorized Representatives before any device registration application is accepted.

The AR serves as NHRA's in-country regulatory contact and typically:

• Holds the manufacturer authorization letter appointing the AR for Bahrain
• Manages device listing and registration dossiers
• Receives fee payment notices and approval communications through NHRA systems
• Coordinates annual renewal with updated technical documentation

Foreign manufacturers without a Bahrain presence cannot register devices directly. Appoint an AR early—listing and Ajheza submission depend on AR status being active on NHRA records.

Device listing: listing form to medical_devices@nhra.bh

Before submitting registration applications, NHRA requires applicants to list all devices by submitting the listing form to medical_devices@nhra.bh.

The listing step is a separate gate from the full registration dossier:

1. Complete the NHRA device listing form with product identifiers, classification, and manufacturer details
2. Email the form to medical_devices@nhra.bh
3. Pay the BD 5 per device listing fee when invoiced through NHRA's payment process
4. Obtain listing confirmation before proceeding to Ajheza appointment and full registration submission

Listing creates the product record NHRA expects to match against your registration application. Mismatches between listed device name, GMDN code, and registration dossier are a common cause of query cycles.

Ajheza appointment and registration submission

Bahrain's government service description on bahrain.bh states that a prior appointment must be booked and an online application submitted in accordance with Resolution 48/2020. NHRA's registration guidance describes submission through the Ajheza system: book an appointment, then submit all required documents at the booked date and time.

Ajheza workflow (standard route):

Step 1 — AR registration confirmed with NHRA
Step 2 — Device listing form emailed to medical_devices@nhra.bh
Step 3 — Book Ajheza appointment (ajheza.nhra.bh)
Step 4 — Upload required documents at scheduled slot
Step 5 — NHRA review (20 working days standard / 10 fast track)
Step 6 — Fee payment notice issued through system
Step 7 — Registration certificate issued (1-year validity)
Step 8 — Device published on NHRA registered devices list

NHRA's registration page also references the Madar e-service for online document submission and fee notices. Verify the active submission portal on nhra.bh at the time of your application—Ajheza remains the appointment-based channel described in NHRA's published registration guideline and on bahrain.bh.

For the physical service route, bahrain.bh lists submission through Medspero Company or Adliya Business Center Co., with initial review before the file is directed to NHRA for final review. The eService route follows the same logical steps: submit application, attach documents, pay fees, receive reference number, full review, registration number, final fee payment, certificate issuance.

NHRA main office: Building 612, Road 1011, Block 410 – Sanabis, Capital Governorate.

Required documents under Resolution 48/2020

The bahrain.bh government service catalogue lists mandatory attachments for medical device registration:

NHRA may request additional documents during review. Reference market approvals (e.g., Saudi Arabia, USA, EU, Japan, Switzerland) strengthen the file but do not replace Resolution 48/2020 document requirements.

Submission attempt rules

NHRA's registration guideline allows applicants up to three submission attempts to fulfill requirements after a query, without repaying application fees, provided a new Ajheza appointment is booked for each resubmission. If the third attempt still fails, the application is rejected and fees must be paid again for a fresh submission. Plan dossier quality control before the first Ajheza slot to avoid calendar delays.

Step-by-step registration workflow

1. Confirm device scope — Verify product is a registrable medical device under NHRA classification guidance; determine risk class (low / medium / high).
2. Appoint and register AR — Execute manufacturer–AR agreement; complete NHRA AR registration before any listing or application.
3. Submit listing form — Email completed listing form to medical_devices@nhra.bh for each device; pay BD 5 listing fee per device.
4. Assemble Resolution 48/2020 dossier — Collect all bahrain.bh required attachments plus labeling per NHRA labelling guideline.
5. Book Ajheza appointment — Schedule submission slot through Ajheza; align internal QA review with appointment date.
6. Upload documents at appointment — Submit complete dossier at booked date/time; obtain reference number.
7. Pay registration fees — Respond to fee notice (risk-tier amount per bahrain.bh schedule).
8. Respond to NHRA queries — Address deficiencies within the three-attempt framework; rebook Ajheza if resubmission required.
9. Receive registration certificate — Valid one year from issuance; confirm device appears on NHRA registered devices list.
10. Plan annual renewal — Calendar renewal before expiry with updated FSC, QMS certificate, and post-market data.

Registration checklist

• Device classified under NHRA risk rules (low / medium / high)
• Authorized Representative registered with NHRA MDR department
• Manufacturer–AR authorization letter executed and not expired
• Listing form submitted to medical_devices@nhra.bh for each device SKU
• BD 5 listing fee paid per device
• GMDN code confirmed and consistent across listing form and declaration of conformity
• Declaration of conformity includes device safety level and GMDN
• ISO 13485 (or equivalent QMS) certificate current
• Free Sale Certificate from reference market obtained
• Technical specifications and IFU finalized
• Device identification card matches commercial labeling
• Manufacturer relationship letter discloses actual manufacturer and invoice issuer
• Countries marketed list and reference approvals compiled
• Labeling reviewed against NHRA Medical Device Labelling guideline
• Ajheza appointment booked; dossier uploaded at scheduled slot
• Registration fee budget confirmed (BD 150 / 300 / 1,000 by risk tier)
• Renewal calendar set for one-year certificate validity

Common pitfalls

1. Skipping device listing — NHRA requires listing via medical_devices@nhra.bh before registration applications; listing and registration are separate gates.
2. Unregistered AR submitting applications — Only NHRA-registered Authorized Representatives may file; manufacturer direct submission is not accepted.
3. GMDN mismatch — Listing form, declaration of conformity, and labeling must use the same GMDN code.
4. Underestimating dual fees — Budget BD 5 listing plus risk-tier registration fee for each device.
5. Expired QMS or FSC at review — NHRA checks certificate validity dates; stale documents trigger queries.
6. Missing manufacturer relationship letter — bahrain.bh explicitly requires disclosure of actual manufacturer vs. legal manufacturer and invoice issuer.
7. Ignoring three-attempt limit — Repeated incomplete submissions after the third attempt require full fee repayment and restart.
8. Late renewal — One-year certificates lapse; expired registration blocks lawful marketing.

FAQ

Who can register medical devices with Bahrain NHRA?

Only applicants registered as medical device Authorized Representatives (ARs) with NHRA may submit registration applications. Foreign manufacturers must appoint a Bahrain AR who holds the manufacturer authorization and manages listing, Ajheza submission, and renewal.

What is Ministerial Resolution No. 48 of 2020?

Resolution 48 of 2020 is Bahrain's ministerial resolution on quality control of medical devices and products. It is the legal basis cited on bahrain.bh for mandatory NHRA registration before marketing medical devices in the Kingdom.

How do I list a device before registration?

Submit the NHRA listing form to medical_devices@nhra.bh before filing registration applications. NHRA charges BD 5 per device for the listing request. Listing must be completed for each device you intend to register.

How does the Ajheza appointment system work?

Ajheza is NHRA's appointment-based submission platform. Book an appointment through Ajheza, then upload all required Resolution 48/2020 documents at the scheduled date and time. Standard NHRA review is 20 working days after complete submission; fast track is 10 working days through recognized conformity assessment routes.

What are the NHRA registration fees on bahrain.bh?

Published fees include BD 5 per device listing request, BD 150 (low risk first registration), BD 300 (medium risk first), BD 1,000 (high risk first), and renewals of BD 100, BD 200, and BD 700 respectively. Verify current amounts on bahrain.bh before payment.

How long is an NHRA registration certificate valid?

Registration certificates are valid for one year. Renewal requires updated documentation and payment of the applicable renewal fee for your device's risk class. Plan renewal before expiry to avoid marketing interruption.

What is the difference between normal and fast-track review?

The normal route takes 20 working days on bahrain.bh. Fast track takes 10 working days when submission follows NHRA's recognized conformity assessment body pathway. Both routes require the same core document set under Resolution 48/2020.

Can I use Saudi SFDA or India CDSCO approval instead of registering in Bahrain?

Reference market approvals from jurisdictions such as Saudi Arabia (SFDA) or India (CDSCO) support your NHRA dossier but do not replace Bahrain registration. You must still complete AR registration, device listing, Ajheza submission, and obtain an NHRA certificate under Resolution 48/2020.

Official sources

• NHRA Medical Device Registration: https://www.nhra.bh/Departments/MDR/Registration/Medical%20Device/
• NHRA Medical Devices & Supplies Control Section: https://www.nhra.bh/Departments/MDR/
• Bahrain Government Services — Medical device registration (Resolution 48/2020, fees, documents): https://www.bahrain.bh/wps/portal/en/BNP/ServicesCatalogue/GSX-UI-PServiceDetails?psID=1643
• NHRA contact email: medical_devices@nhra.bh