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Bahrain medical device government fees

Row-level verified

NHRA current fee schedule, reviewed for 2026, in BHD.

36 fee lines100% exact amountscurrency BHDFX rates 2026-09-17reviewed 2026-09-16
Fee lineOfficial amountUSD equivalentFrequencyProvenance
Application to submit a medical device registration
Table 2. Charged in addition to the risk-based registration or renewal fee below.
BHD 5$13.30Each applicationVerified
Medical Device & Supplies traceability fee
Table 2. This line does not appear in Resolution No. (24) of 2021 and is new in Circular No. (15) of 2026; it is charged per individual device, not per model.
BHD 5$13.30Each individual deviceVerified
Low risk medical device registration or renewal
Table 2, norm column 'Triannual per license'.
BHD 150$399Every 3 years per licenceVerified
Medium risk medical device registration or renewal
Table 2, norm column 'Triannual per license'.
BHD 300$798Every 3 years per licenceVerified
High risk medical device registration or renewal
Table 2, norm column 'Triannual per license'. This is the highest device-registration fee in the schedule.
BHD 1,000$2,660Every 3 years per licenceVerified
Update medical device registration data
Table 2.
BHD 20$53.19Each deviceVerified
Authorized Representative licence application fee
Table 1. Only a facility licensed by NHRA as a Medical Device Authorized Representative may hold a device registration, so this licence is a precondition of every registration.
BHD 50$133Each new orderVerified
Authorized Representative licence, Class A — first licence
Table 1. The class-licence fee decreases as the class number rises, as printed.
BHD 1,000$2,660First licenceVerified
Authorized Representative licence, Class A — renewal
Table 1.
BHD 700$1,862AnnualVerified
Authorized Representative licence, Class B — first licence
Table 1.
BHD 700$1,862First licenceVerified
Authorized Representative licence, Class B — renewal
Table 1.
BHD 500$1,330AnnualVerified
Authorized Representative licence, Class C — first licence
Table 1.
BHD 500$1,330First licenceVerified
Authorized Representative licence, Class C — renewal
Table 1.
BHD 300$798AnnualVerified
Authorized Representative licence, Class D — first licence
Table 1.
BHD 300$798First licenceVerified
Authorized Representative licence, Class D — renewal
Table 1.
BHD 200$532AnnualVerified
Medical devices warehouse licensing — first licence
Table 1.
BHD 1,000$2,660First licenceVerified
Medical devices warehouse licensing — renewal
Table 1.
BHD 800$2,128AnnualVerified
Medical devices manufacturer licensing — first licence
Table 1. Applies to a local manufacturing site licensed by NHRA, not to the foreign legal manufacturer.
BHD 5,000$13,298First licenceVerified
Medical devices manufacturer licensing — renewal
Table 1.
BHD 3,000$7,979AnnualVerified
Update medical device facilities data
Table 1.
BHD 50$133Each requestVerified
Re-inspection of medical device facilities
Table 1.
BHD 50$133Each requestVerified
Request approval to import a single registered medical device
Table 3. Bahraini Dinar is a three-decimal currency; the annex prints this as 0.5.
BHD 0.500$1.33Each typeVerified
Request approval to import a single unregistered medical device
Table 3. Four times the registered-device rate.
BHD 2$5.32Each typeVerified
Request approval to import a single registered IVD or combined medical device
Table 3.
BHD 1$2.66Each typeVerified
Request approval to import a single unregistered IVD or combined medical device
Table 3.
BHD 3$7.98Each typeVerified
Verify the validity of the quality certificate
Table 3.
BHD 5$13.30Each typeVerified
Product classification request — regular
Table 3. The classification letter is a precondition of importation and of registration.
BHD 20$53.19Each typeVerified
Product classification request — urgent
Table 3.
BHD 40$106Each typeVerified
Demurrage for the device until approval
Table 3. Charged while a shipment waits for approval, which is why the importation guideline requires the OFOQ request to be filed before shipping.
BHD 100$266Per day per shipmentVerified
Issuing a product classification certificate
Table 3.
BHD 15$39.89Each certificateVerified
Sample examination
Table 3.
BHD 5$13.30Each typeVerified
Inspecting the shipment at the port
Table 3.
BHD 10$26.60Each typeVerified
Submit a request for approval to use the device — permit to use device
Table 4.
BHD 0.500$1.33Each deviceVerified
Evaluate the viability of the product
Table 4.
BHD 50$133Each deviceVerified
Issuing certificates for medical manufacturer and devices, free sale and other paper documents
Table 4.
BHD 10$26.60Each requestVerified
Product disposal supervising
Table 4.
BHD 25$66.49Each requestVerified
Government fees only — service and testing costs are separate
  • Circular No. (15) of 2026 is dated 9 June 2026 and states that the schedule 'shall be applied from 1 May 2026, unless otherwise instructed by NHRA'; it is issued in reference to Resolution No. (24) of 2021, which amended Resolution No. (20) of 2016 on the categories of fees for private healthcare facilities, and in accordance with Resolution No. (48) of 2020 on the control of the quality of medical devices and products.
  • The circular is a scanned annex with no text layer; every amount here was read from the page images and cross-checked across two OCR passes. All fees are stated in Bahraini Dinar.
  • Table 2 states in terms that 'All medical device registrations have a 3-year validity period', which is consistent with the three-year marketing authorisation introduced by Resolution No. (69) of 2024 and inconsistent with the one-year validity still printed in Registration Guideline Version 9.1 — see unresolved.registrationValidity.
  • The risk-based registration fee is charged per licence for a three-year period, not per product or per application: the BHD 5 application fee and the BHD 5 per-device traceability fee are separate lines.
  • The Medical Device Registration SLA 2025 still cites its fee column to 'the table in (b) of the Minister of Health's Resolution No. (24) of 2021'; Circular No. (15) of 2026 is the later instrument and supersedes it for the services it lists.
  • Radio type-approval fees are charged by the TRA (BHD 100 application, BHD 10 renewal and BHD 80 modification for telecommunications equipment; BHD 50 / 10 / 40 for terminal devices and for short range devices) and form no part of this NHRA record — see unresolved.radioTypeApprovalFees.
  • The Supreme Council for Environment publishes no amount for its ionizing-radiation permits; its service page states only that the fee depends on the type and number of ionizing radiation sources, so no amount for it is published here.
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Exact amounts verified against the NHRA fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:bahrain:medical-device-registration-application