🇱🇧 Lebanon IVD regulatory data

lebanon:medical-device

lebanon

• medical-device
• ivd

Lebanese risk levels: Low risk, Low-To-Moderate, Moderate-To-High and High, aligned band-by-band to the EU, US, Japanese, Australian, Swiss and Canadian classes

Decision No. 1506/1 of 1 September 2014 Art. Three classifies devices by level of risk (Classification) according to a table that maps four Lebanese levels onto the classes of six reference regulators: Low risk = EU I, US I, Japan I, Australia I, Swiss I, Canada I; Low-To-Moderate = EU II-a, US II, Japan II, Australia I-m / II a / Is, Swiss II-a, Canada II; Moderate-To-High = EU II-b, Japan III, Australia II-b, Swiss II-b, Canada III; High = EU III, US III, Japan IV, Australia III, Swiss III, Canada IV. Art. Two classifies and codes devices under the globally adopted Global Medical Devices Nomenclature (GMDN), and the table's footnote refers the conformity documents accepted for the European system to the annex by risk level (Annex 1). Decision 455/1 of 16 April 2013 Art. One draws the underlying rule for imported goods: the mandatory Lebanese specifications apply where they exist and, where they do not, the non-mandatory Lebanese specifications or the European Union's requirements or those of the United States, Canada, Japan or Australia.

• Id

  low

  Label

  Low risk (EU I, US I, Japan I, Australia I, Swiss I, Canada I)

  Normalized Risk Level

  low

• Id

  low-to-moderate

  Label

  Low-To-Moderate (EU II-a, US II, Japan II, Australia I-m / II a / Is, Swiss II-a, Canada II)

  Normalized Risk Level

  medium

• Id

  moderate-to-high

  Label

  Moderate-To-High (EU II-b, Japan III, Australia II-b, Swiss II-b, Canada III)

  Normalized Risk Level

  high

• Id

  high

  Label

  High (EU III, US III, Japan IV, Australia III, Swiss III, Canada IV)

  Normalized Risk Level

  highest

Ministry of Public Health (وزارة الصحة العامة)

• moph.gov.lb

official-source-verified

• Title

  Ministerial Decision No. 455/1 of 16 April 2013, Art. One — the conformity rule for imported medical equipment, instruments and supplies

  Url

  https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Laws%20and%20Regulations/karar%20455-2013.pdf

  Reviewed On

  2026-09-16

  Supports

  The level the device carries under Decision 1506/1 Art. Three also selects the accepted conformity documents, because Art. One of Decision 455/1 accepts the European Union's requirements or those of the United States, Canada, Japan or Australia where no mandatory Lebanese specification exists, and Art. Three of Decision 1506/1 attaches the European-system documents to the risk level.

• Title

  Ministry of Public Health — Medical Technology page: the Ministry's register of device instruments (Decision 455 of 16/4/2013, Decision 1506 of 1/9/2014, Decision 1704-1 of 12/9/2017, Decision 181-1 of 30/1/2018) and the MEDRES device registration system

  Url

  https://www.moph.gov.lb/en/Pages/3/2275/medical-technology

  Reviewed On

  2026-09-16

  Supports

  The Ministry's own register dates the classification instrument to 1 September 2014 and lists it with the other three device decisions, which is what ties the class axis to the instrument rather than to a secondary description of it.

• Title

  Ministry of Public Health — list of registered implantable medical devices: the registration of device procedures at the Ministry and the National List of Implantable Medical Devices

  Url

  https://www.moph.gov.lb/en/Pages/4/8262/list-of-registered-implantable-medical-devices-at-moph

  Reviewed On

  2026-09-16

  Supports

  The registration route the classes feed into: the Ministry states that all implantable medical devices must be registered on the National List of Implantable Medical Devices before their first commissioning, using a harmonised coding system, and that the system is being implemented with the Agence française de sécurité du médicament et des produits de santé (ANSM).

Ministerial Decision No. 1506/1 of 1 September 2014 — أحكام توضيحية لتطبيق القرار رقم 1/455 (explanatory provisions for the application of Decision 455/1): Art. Two (GMDN classification and coding), Art. Three (classification by level of risk, the EU/US/Japan/Australia/Swiss/Canada table and Annex 1 documents by risk level)

https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Laws%20and%20Regulations/karar%201506-2014.pdf

2026-09-16

• class-axis
• classification-rules
• ivd-class-axis
• ivd-classification-rules

Lebanon

lebanon

LB

🇱🇧

Ministry of Public Health (وزارة الصحة العامة) — the device file is handled by the Health Technology Unit (unité des technologies de la santé) with the Health Engineering Service (Département de génie sanitaire / مصلحة الهندسة الصحية) and the Pharmacy Service's Import/Export department, the implantable registration request is lodged with the Department of Programs and Projects (دائرة البرامج والمشاريع) under Decision 455/1 Art. Six, and the entry permit is granted by the Health Engineering Service under Art. Four

Ministry of Public Health

middle-east

3

4 national levels — Low risk, Low-To-Moderate, Moderate-To-High and High — set by Decision 1506/1 of 1 September 2014 Art. Three and mapped band-by-band to the EU (I, II-a, II-b, III), US (I, II, —, III), Japanese (I, II, III, IV), Australian (I, I-m/II a/Is, II-b, III), Swiss (I, II-a, II-b, III) and Canadian (I, II, III, IV) classes, with GMDN classification and coding under Art. Two

• Id

  device-import-entry-permit

  Class Name

  Entry and import approval for medical devices, instruments and supplies of all risk levels — form MPH12-26

  Pathway

  Application on the official form to the Ministry of Public Health with the device invoice, the specifications catalogue and the letter of the beneficiary, together with the Atomic Energy Authority's import approval where the request calls for it; the invoice must bear the Atomic Energy stamp, the conformity certificate is issued by the Industrial Research Institute, and the Health Engineering Service then grants the entry permit

  Official Timeline

  Min

  7

  Max

  14

  Unit

  days

  Verification Status

  official-verified

  Official Source

  Title

  Ministry of Public Health — administrative service record for طلب الموافقة على إدخال أو إستيراد أجهزة, form MPH12-26: required documents, the Atomic Energy stamp condition, the LBP 1,000 fiscal stamp, submission on all official working days, and 'مدة انتهاء المعاملة: بين أسبوع وأسبوعين'

  Url

  https://www.moph.gov.lb/ar/AdministrativeServices/details/4

  Accessed Date

  2026-09-16

  Realistic Timeline

  Min

  1

  Max

  2

  Notes

  • Official clock: the Ministry's service record for the device entry/import approval publishes the transaction period (مدة انتهاء المعاملة) as 'between one week and two weeks' and accepts applications on all official working days. The same record fixes the documents — the MPH12-26 form duly completed, an invoice giving the device name and specifications (new and unused, or renewed) and the exporting company, the Lebanese Atomic Energy Authority's approval for import or export as requested, the device specification catalogue and a letter from the party for whom the device or materials are requested — the condition that the invoice bear the Atomic Energy stamp, and the LBP 1,000 fiscal stamp.
  • The record states weeks rather than working days, so the range is published as 7 to 14 calendar days; it is the only published period for the general device entry route.
  • The clock is route-wide: the Ministerial Decision 1506/1 Art. Three levels change the documentary burden — which European-system conformity documents are accepted under Annex 1 by level — not the period, and the service record draws no distinction between devices of different levels.
  • Related service records publish no period at all: the sterile medical instruments import (MPH212-9) and the medical or laboratory reagents import (MPH212-3) both leave the processing-period field blank, while medical consumables for a health centre (MPH311-1) publishes 'خلال 15 يوم' — within 15 days. Only the general device entry/import record publishes a period, which is why that record is the bound clock for this row.
  • The 1-2 week period is the permit clock, not a promise for the whole first-entry path: before the permit the goods must satisfy the Industrial Research Institute's conformity certificate (Decision 455/1 Arts. One, Three, Four) — the Ministry's sterile-instrument record names an 'إفادة مطابقة من معهد البحوث' — and an implantable must already be registered with the Department of Programs and Projects (Decision 455/1 Art. Six), neither of which carries a published period.
  • The service record carries no revision date and no instrument read states the period, so it is published as the current service catalogue's own statement; the state of the Ministry's service catalogue and of the registration system after the country's recent crises is recorded in unresolved rather than assumed.

  Clinical Trial Required

  No

  Local Testing Required

  No

  Gmp Required

  No

• Authority

  US FDA (510(k)/PMA approval or approval letter), European Union (conformity certificate issued by the manufacturer and by EU-notified bodies), Swiss, Australian, Canadian or Japanese competent health authorities (conformity certificate)

  Accepted

  Yes

  Benefit

  Accepted and in practice required for an implantable device: Decision 455/1 Art. Six lists them as the conformity documents that go into the registration file — a European-standards certificate from the manufacturer and EU-notified bodies, an FDA marketing approval or approval letter, or a conformity certificate from the health authorities of Switzerland, Australia, Canada or Japan — and Decision 1506/1 Art. Four requires a GHTF/IMDRF free-sale certificate on top. The Ministry's service records for sterile instruments and laboratory reagents require FDA evidence for US-origin goods and CE evidence for European ones. The benefit is documentary, not a shortened clock: none of the instruments publishes an abbreviated examination period, and the registration certificate is still issued on the Health Technology Unit's advice to the Minister.

• Authority

  GHTF/IMDRF member countries — free-sale certificate (شهادة بيع حر)

  Accepted

  Yes

  Benefit

  A mandatory document rather than a route: Decision 1506/1 Art. Four requires the registration application to carry a free-sale certificate issued by a country belonging to the GHTF/IMDRF group, meaning the device is sold in one of those countries whatever its origin, and the Ministry's service records require a free-sale certificate with an ISO 13485 certificate where the goods are made outside the reference states or the listed documents cannot be produced. No examination period is shortened by it.

• Authority

  Korea MFDS, China NMPA and other non-reference approvals, and the manufacturer's ISO 13485 certificate as the documentary route for goods from other origins

  Accepted

  No

  Benefit

  Not accepted as a reference authorisation: Decision 455/1 Art. Six lists the European Union, the United States, Switzerland, Australia, Canada and Japan, and Decision 1506/1 Art. Four the GHTF/IMDRF group, but neither names Korea or China. A device made in or imported from a country outside that list follows the Industrial Research Institute's certificate against Lebanese or international reference specifications, with the manufacturer's ISO 13485 certificate accepted as evidence in the service records for sterile instruments and reagents — a documentary route that carries no recognition and shortens no period.

• File the device entry/import approval on form MPH12-26 with the Ministry's Health Engineering Service, with the invoice naming the device and its specifications (new and unused, or renewed) and the exporting company, the device specification catalogue and the letter of the beneficiary; the invoice must bear the Atomic Energy stamp (service record 4).
• Obtain the Lebanese Atomic Energy Authority's approval for import or export where the request calls for it, and expect the Authority's stamp to be a condition on the invoice (service record 4).
• Obtain the Industrial Research Institute's conformity certificate: Decision 455/1 Arts. One and Three impose a conformity certificate on all imported equipment, instruments and supplies, verify it through the mechanism of Decree No. 5305 of 28 October 2010, and accredit the Institute to issue every certificate under Art. One; Art. Four withholds the entry permit and the customs stamping until it is produced.
• Where no mandatory Lebanese specification exists, demonstrate conformity with the European Union's requirements or those of the United States, Canada, Japan or Australia (Decision 455/1 Art. One).
• For an implantable device, file the registration request with the Department of Programs and Projects before the entry declaration, with the DMI-01 identification card, the user manual, the labels on the implant packaging, a copy of the manufacturer's invoice and a conformity certificate from a reference authority (or the Institute's certificate for locally made or non-reference-origin goods) (Decision 455/1 Art. Six).
• Add the free-sale certificate issued by a country belonging to the GHTF/IMDRF group, showing the device is sold in one of those countries whatever its origin (Decision 1506/1 Art. Four).
• Classify and code the device under the GMDN nomenclature and assign its level from the Decision 1506/1 Art. Three table (Low risk, Low-To-Moderate, Moderate-To-High, High), accepting the European-system conformity documents named in Annex 1 according to that level.
• Declare as a supplier with a commercial-register number, the manufacturer's authorisation for the products, the traceability undertakings and the evidence documents, and use the credentials the Ministry issues to work in the online device registration system (November 2013 procedure §6.2 items 15-17); the Ministry's authorisation is given for one renewable year (§6.2 item 18).
• Keep the conformity certificates of devices recorded in the registration system up to date, and upload the import invoices of implanted devices through the computerised system; the Pharmacy Service's import department and the Health Engineering Service stop stamping invoices that are not uploaded (Decision 1704/1 Arts. Two, Six, from 1 December 2017; Decision 181/1 Art. Three, from 16 March 2018).
• Pay the LBP 1,000 fiscal stamp due on the application, and settle the charge imposed by Law No. 193 of 18 November 2011 in favour of the Beirut and Tripoli physicians' syndicate under the joint decision of the Ministers of Public Health and Finance No. 180/1 of 15 February 2012, which Decision 455/1 Art. Four makes a condition of the entry permit.
• For a device that is also radio or telecommunications terminal equipment, obtain the TRA's type approval, filing the Ministry of Telecommunications' import licence for importers, a Technical Compliance Folder (frequency and maximum EIRP, drawings, photographs, specification list, ISO/IEC 17025- or ILAC-accredited test reports) and a Declaration of Conformity (TRA Type Approval Regulation).
• Report any withdrawal of a product's marketing authorisation to the Ministry, and report the newly authorised supplier (November 2013 procedure §6.2 item 19); the Ministry may refuse, suspend or withdraw a registration certificate, with 60 days from notification to regularise (§7.2.2).

Yes

Declared local supplier / importer (المورّد / المستورد المصرّح له) — a company holding a commercial-register number, authorised by the manufacturer for the products and given credentials by the Ministry for the online device registration system

No

No MDSAP route: the instruments name the reference-regulator approvals and the GHTF/IMDRF free-sale certificate, and no MDSAP audit report is accepted in their place; the manufacturer's ISO 13485 certificate appears in the Ministry's service records as documentary evidence for goods from outside the reference states, not as a recognised assessment, and it shortens no period.

No validity period is stated in the decisions: Decision 455/1 and Decision 1506/1 fix none, while the Ministry's November 2013 national procedure provides that the registration certificate is issued valid for 5 years, renewable on the beneficiary's request (§7.2.2) and that the supplier authorisation is given for one renewable year (§6.2 item 18); whether the certificate is currently being issued on that period is recorded in unresolved

2026-09-16

partially-verified

• Title

  Ministry of Public Health — administrative service record for طلب الموافقة على إدخال أو إستيراد أجهزة, form MPH12-26: required documents, the Atomic Energy stamp condition, the LBP 1,000 fiscal stamp, submission on all official working days, and 'مدة انتهاء المعاملة: بين أسبوع وأسبوعين'

  Url

  https://www.moph.gov.lb/ar/AdministrativeServices/details/4

  Accessed Date

  2026-09-16

• Title

  Ministerial Decision No. 455/1 of 16 April 2013 — تنظيم إدخال واستعمال المواد الطبية المختلفة: the conformity certificate (Art. One), the Industrial Research Institute as the issuing body (Art. Three), entry permits, the statutory charge and customs stamping (Art. Four), and the pre-registration dossier for implantables with the Department of Programs and Projects (Art. Six)

  Url

  https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Laws%20and%20Regulations/karar%20455-2013.pdf

  Accessed Date

  2026-09-16

• Title

  Ministerial Decision No. 1506/1 of 1 September 2014 — أحكام توضيحية لتطبيق القرار رقم 1/455: GMDN classification (Art. Two), the four risk levels and the reference-regulator class table (Art. Three), the GHTF/IMDRF free-sale certificate (Art. Four), and the import stop-date for implantables not recorded with the Department of Programs and Projects (Art. Six)

  Url

  https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Laws%20and%20Regulations/karar%201506-2014.pdf

  Accessed Date

  2026-09-16

2026-09-16

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

• Step

  1

  Title

  Pre-Submission Preparation

  Description

  Gather technical documentation, quality management system (QMS) records, and clinical data required by Ministry of Public Health. Appoint a Declared local supplier / importer (المورّد / المستورد المصرّح له) — a company holding a commercial-register number, authorised by the manufacturer for the products and given credentials by the Ministry for the online device registration system.

  Duration

  1-3 months

  Icon

  📋

• Step

  2

  Title

  Application Submission

  Description

  Submit complete registration dossier to Ministry of Public Health including device description, risk analysis, and testing reports.

  Duration

  1-2 weeks

  Icon

  📤

• Step

  3

  Title

  Administrative Review

  Description

  Ministry of Public Health reviews application for completeness. May request additional documents or clarifications.

  Duration

  2-4 weeks

  Icon

  🔍

• Step

  4

  Title

  Technical Evaluation

  Description

  In-depth technical assessment of device safety and performance. Ministry of Public Health may issue questions.

  Duration

  7-14 days

  Icon

  ⚙️

• Step

  5

  Title

  Registration Approval

  Description

  Upon successful review, Ministry of Public Health issues Lebanon market authorization certificate.

  Duration

  1-2 weeks

  Icon

  ✅

lebanon

Lebanon

LB

Ministry of Public Health

Min

1000

Max

1000

Currency

LBP

Per Product

No

Min

1000

Max

1000

Currency

LBP

Per Product

No

• Id

  device-entry-import-approval-fiscal-stamp

  Item

  Fiscal stamp on the device entry or import approval (form MPH12-26)

  Currency

  LBP

  Amount Local

  1000

  Amount Local Formatted

  LBP 1,000

  Frequency

  Per application

  Notes

  The Ministry's service record for the device entry/import approval publishes the fee due as 'الرسوم المتوجبة: طابع مالي بقيمة 1000 ل.ل.' — a fiscal stamp of LBP 1,000 — with no differentiation by device level and no revision or effective date.

  Amount Status

  exact-current

  Verification Status

  official-verified

  Source Url

  https://www.moph.gov.lb/ar/AdministrativeServices/details/4

  Source Title

  Ministry of Public Health — administrative service record for طلب الموافقة على إدخال أو إستيراد أجهزة (approval to enter or import devices), form MPH12-26: 'الرسوم المتوجبة: طابع مالي بقيمة 1000 ل.ل.'

  Verified On

  2026-09-16

• Id

  sterile-instruments-import-fiscal-stamp

  Item

  Fiscal stamp on the sterile medical instruments import application (form MPH212-9)

  Currency

  LBP

  Amount Local

  1000

  Amount Local Formatted

  LBP 1,000

  Frequency

  Per application

  Notes

  The same LBP 1,000 fiscal stamp, which the service record states is stuck on the application (يلصق على الطلب); the record's processing-period field is blank, so this row carries the charge only.

  Amount Status

  exact-current

  Verification Status

  official-verified

  Source Url

  https://www.moph.gov.lb/ar/AdministrativeServices/details/61

  Source Title

  Ministry of Public Health — administrative service record for طلب استيراد أدوات طبية معقّمة (import of sterile medical instruments), form MPH212-9: 'الرسوم المتوجبة: طابع مالي بقيمة 1000 ل.ل. يلصق على الطلب'

  Verified On

  2026-09-16

• Id

  reagents-import-fiscal-stamp

  Item

  Fiscal stamp on the medical or laboratory reagents import application (form MPH212-3)

  Currency

  LBP

  Amount Local

  1000

  Amount Local Formatted

  LBP 1,000

  Frequency

  Per application

  Notes

  The same LBP 1,000 fiscal stamp on the application (يلصق على الطلب المقدم); this route covers reagents, culture media and biological samples, and its processing-period field is likewise blank.

  Amount Status

  exact-current

  Verification Status

  official-verified

  Source Url

  https://www.moph.gov.lb/ar/AdministrativeServices/details/67

  Source Title

  Ministry of Public Health — administrative service record for طلب استيراد كواشف طبية او مخبرية (import of medical or laboratory reagents), form MPH212-3: 'الرسوم المتوجبة: طابع مالي بقيمة 1000 ل.ل. يلصق على الطلب المقدم'

  Verified On

  2026-09-16

• The Ministry publishes no device-registration tariff. Its MoPH Tariffs page carries only hospital flat rates, a pathology and laboratory price list, an implant list used for hospital billing and an NSSF radiology list, and no instrument read fixes a registration or listing fee, so nothing is published here as a registration fee — the rows are the published charges that actually attach to a device application.
• The three rows are one charge on three applications: the same LBP 1,000 fiscal stamp is published on the device entry/import approval, on the sterile medical instruments import and on the medical or laboratory reagents import. The stamp is a Treasury charge, not a risk-differentiated tariff, and the service records carry neither a revision nor an effective date, so the amount is published as what the current service catalogue states.
• A separate value-based charge applies on the same route and is not tabulated as an exact row: Decision No. 455/1 Art. Four conditions the entry permit on payment to the physicians' syndicate of the charge imposed by Law No. 193 of 18 November 2011 (amending the retirement-fund law of the Beirut and Tripoli physicians' syndicates), under the joint decision of the Ministers of Public Health and Finance No. 180/1 of 15 February 2012. That provision sets the charge at 2% of the FOB price of all medical supplies, equipment and instruments (0.5% on medicines and prepared pharmaceutical products), collected by the importer as stamps on the invoice — a percentage of value, computed by formula rather than a fixed amount, so it is not tabulated as an exact row.
• The implant price list the Ministry publishes (MoPH Implants for Check List) is a hospital reimbursement schedule with per-item prices, not a regulatory fee, and forms no part of this record.
• The fixed stamp is charged per application rather than per device, so the bands are marked perProduct false; a consignment of several devices pays the stamp once.

2026-09-16

official-verified

• Title

  Ministry of Public Health — administrative service record for طلب الموافقة على إدخال أو إستيراد أجهزة (approval to enter or import devices), form MPH12-26: 'الرسوم المتوجبة: طابع مالي بقيمة 1000 ل.ل.'

  Url

  https://www.moph.gov.lb/ar/AdministrativeServices/details/4

  Accessed Date

  2026-09-16

• Title

  Ministry of Public Health — administrative service record for طلب استيراد أدوات طبية معقّمة (import of sterile medical instruments), form MPH212-9: 'الرسوم المتوجبة: طابع مالي بقيمة 1000 ل.ل. يلصق على الطلب'

  Url

  https://www.moph.gov.lb/ar/AdministrativeServices/details/61

  Accessed Date

  2026-09-16

• Title

  Ministry of Public Health — administrative service record for طلب استيراد كواشف طبية او مخبرية (import of medical or laboratory reagents), form MPH212-3: 'الرسوم المتوجبة: طابع مالي بقيمة 1000 ل.ل. يلصق على الطلب المقدم'

  Url

  https://www.moph.gov.lb/ar/AdministrativeServices/details/67

  Accessed Date

  2026-09-16

• Title

  Ministerial Decision No. 455/1 of 16 April 2013, Art. Four — the entry permit issues after the legal conditions are met, including the conformity certificate issued by the Industrial Research Institute and payment of the charge imposed by Law No. 193 of 18 November 2011 to the Beirut and Tripoli physicians' syndicate under the joint decision of the Ministers of Public Health and Finance No. 180/1 of 15 February 2012

  Url

  https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Laws%20and%20Regulations/karar%20455-2013.pdf

  Accessed Date

  2026-09-16

2026-09-16

exact-current

Yes

lebanon

Lebanon

low

• Id

  lebanon-tra-rtte-type-approval

  Name

  TRA type approval for radio and telecommunications terminal equipment

  Category

  Radio Spectrum

  Status

  Mandatory If Feature

  Object

  Radio And Terminal Equipment

  Note

  The Telecommunications Regulatory Authority publishes the Type Approval Regulation issued by Decision No. 5/2009 in Official Gazette Issue 17 of 16 April 2009, as modified by Modification Decision No. 3/2026, and states that under the Minister of Telecommunications' Decision No. 1/624 of 10/11/2025 the issuance of type-approval certifications has moved to the TRA. The file requires the Ministry of Telecommunications' import licence for importers, the type-approval application form, a Technical Compliance Folder (operating frequency and maximum EIRP, drawings and schematics, internal and external photographs, the specification list, and test reports from a laboratory accredited to ISO/IEC 17025 or an ILAC member) and the applicant's Declaration of Conformity. Fees are published by Board Decision No. 9/2025: LBP 15,000,000 (scheme 1), LBP 25,000,000 (scheme 2), LBP 41,000,000 (scheme 3) and LBP 8,500,000 for renewal. A radio-equipped medical device therefore carries a telecom type approval alongside the Ministry of Public Health device file, and that tariff sits with the telecom regime rather than in the device fee schedule.

  Source Urls

  • https://www.tra.gov.lb/Type-approval-Regulation

  Source Binding

  reviewed

• Id

  lebanon-laec-import-export-approval

  Name

  Lebanese Atomic Energy Authority approval to import or export a device

  Category

  Ionizing Radiation

  Status

  Mandatory If Feature

  Object

  Radiation Emitting Device

  Note

  The Ministry's own administrative-service record for the device entry/import approval lists among the required documents 'موافقة الهيئة اللبنانية للطاقة الذرية على الإستيراد أو التصدير حسب الطلب' — the Lebanese Atomic Energy Authority's approval for import or export as requested — and makes it a condition that the device invoice bear the Atomic Energy stamp (يجب أن تكون الفاتورة الخاصة بالجهاز ممهورة بختم الطاقة الذرية). A radiation-emitting device (diagnostic X-ray, fluoroscopy or radiotherapy equipment, or a device containing a sealed source) therefore carries the Authority's import approval alongside the Ministry file and the Industrial Research Institute's conformity certificate. Two limits: the requirement is asserted on the Ministry's service record because the Authority's own licensing instrument could not be retrieved (laec.gov.lb did not resolve and cnrs.edu.lb refused the request), and the record words the requirement 'as requested', so which device families fall inside it is recorded in unresolved rather than asserted here.

  Source Urls

  • https://www.moph.gov.lb/ar/AdministrativeServices/details/4

  Source Binding

  reviewed

• Id

  lebanon-iri-conformity-certificate

  Name

  Industrial Research Institute conformity certificate for imported devices

  Category

  Product Specific Conformity

  Status

  Mandatory At Import

  Object

  Imported Medical Device And Supply

  Note

  Decision No. 455/1 of 16 April 2013 Art. One imposes a conformity certificate (شهادة مطابقة) on all imported medical equipment, instruments and supplies. Art. Three verifies that conformity through the mechanism put in force by Decree No. 5305 of 28 October 2010 (تكليف معهد البحوث الصناعية بالتأكد من تطبيق المواصفات الإلزامية) and makes the Industrial Research Institute (معهد البحوث الصناعية) the body accredited to issue all the conformity certificates mentioned in Art. One. Art. Four grants the entry permit only after the legal conditions are met, 'especially the conformity certificate issued by the Industrial Research Institute', and forbids the Ministry's departments from stamping customs declarations unless the declaration is accompanied by those documents. The Ministry's service record for the import of sterile medical instruments requires an 'إفادة مطابقة من معهد البحوث' — a conformity statement from the Institute — with the invoice and the sterilisation certificate. The Institute's own tariff and accreditation scope were not retrieved; whether it can currently test the full device range is recorded in unresolved.

  Source Urls

  • https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Laws%20and%20Regulations/karar%20455-2013.pdf
  • https://www.moph.gov.lb/ar/AdministrativeServices/details/61

  Source Binding

  reviewed

• Id

  lebanon-reference-authority-certificate-and-free-sale-certificate

  Name

  Reference-authority certificate and free-sale certificate in the device registration file

  Category

  Import Conformity

  Status

  Mandatory At Import

  Object

  Imported Medical Device And Supply

  Note

  Decision 455/1 Art. Six requires an application to register an implantable, temporarily or permanently implanted device to be filed with the Department of Programs and Projects together with the implant identification card (DMI-01), the user manual, the labels on the implant packaging, a copy of the manufacturer's invoice and a conformity certificate against international standards issued by one of the following: a European-standards certificate issued by the manufacturer and by EU-notified bodies; a US Food and Drug Administration marketing approval or approval letter; a conformity certificate issued by the competent health authorities of Switzerland, Australia, Canada or Japan; or, for devices made in Lebanon or imported from countries not listed, a certificate of conformity with Lebanese or international reference specifications issued by the Industrial Research Institute. Decision 1506/1 Art. Four adds to those Art. Six documents a free-sale certificate (شهادة بيع حر) issued by a country belonging to the GHTF/IMDRF group, so that the device is sold in one of those countries whatever its origin. The Ministry's service records for sterile instruments and for laboratory reagents similarly require FDA or CE evidence for the imported item, and require a free-sale certificate plus an ISO 13485 certificate where the goods are made in a country outside the reference states or the listed documents cannot be produced.

  Source Urls

  • https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Laws%20and%20Regulations/karar%20455-2013.pdf
  • https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Laws%20and%20Regulations/karar%201506-2014.pdf
  • https://www.moph.gov.lb/ar/AdministrativeServices/details/61
  • https://www.moph.gov.lb/ar/AdministrativeServices/details/67

  Source Binding

  reviewed

• Id

  lebanon-electrical-safety-and-emc

  Name

  Electrical safety and EMC evidence inside the device conformity and import file

  Category

  Medical Electrical Safety

  Status

  Included In Medical Registration

  Object

  Medical Electrical Equipment

  Note

  No separate Lebanese electrical-safety or EMC certificate for medical devices was located in the instruments read, and none is asserted. The evidence enters through the conformity route instead: Decision 455/1 Art. One adopts the European Union's requirements or those of the United States, Canada, Japan or Australia where no mandatory Lebanese specification exists; Decision 1506/1 Art. Three and Annex 1 accept the European-system conformity documents according to the device's risk level; and the certificate attesting all of it is the Industrial Research Institute's, under Decision 455/1 Arts. Three and Four. For a device that is also radio or telecommunications terminal equipment, the TRA's Technical Compliance Folder separately requires test reports from an ISO/IEC 17025- or ILAC-accredited laboratory. Annex 1 of Decision 1506/1 is a scanned table of the European conformity documents and was read only at page level, so which document matches which Lebanese level is recorded in unresolved rather than tabulated here.

  Source Urls

  • https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Laws%20and%20Regulations/karar%20455-2013.pdf
  • https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Laws%20and%20Regulations/karar%201506-2014.pdf
  • https://www.tra.gov.lb/Type-approval-Regulation

  Source Binding

  reviewed

• Authority

  Ministry of Public Health (MoPH)

  Topic

  administrative service record — طلب الموافقة على إدخال أو إستيراد أجهزة (application for approval to enter or import devices), form MPH12-26: required documents including the Atomic Energy Authority's import approval, the invoice conditions, the LBP 1,000 fiscal stamp, the 1-2 week transaction period and the online application link

  Url

  https://www.moph.gov.lb/ar/AdministrativeServices/details/4

• Authority

  Ministry of Public Health (MoPH)

  Topic

  administrative service record — طلب استيراد أدوات طبية معقّمة (import of sterile medical instruments), form MPH212-9: Industrial Research Institute conformity statement, FDA evidence for US origin, CE evidence for European origin, free-sale and ISO certificates for goods from outside the reference states, LBP 1,000 fiscal stamp

  Url

  https://www.moph.gov.lb/ar/AdministrativeServices/details/61

• Authority

  Ministry of Public Health (MoPH)

  Topic

  administrative service record — طلب استيراد كواشف طبية او مخبرية (import of medical or laboratory reagents, culture media, biological samples), form MPH212-3: FDA or CE evidence for imported items, material-safety data sheet, expert chemical report, LBP 1,000 fiscal stamp

  Url

  https://www.moph.gov.lb/ar/AdministrativeServices/details/67

• Authority

  Ministry of Public Health (MoPH)

  Topic

  Ministerial Decision No. 455/1 of 16 April 2013 — تنظيم إدخال واستعمال المواد الطبية المختلفة: conformity certificate for imported devices (Art. One), the information sheet (Art. Two), the Industrial Research Institute as issuing body (Art. Three), entry permits, the statutory charge and customs stamping (Art. Four), and the pre-registration of implantables with the Department of Programs and Projects (Art. Six)

  Url

  https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Laws%20and%20Regulations/karar%20455-2013.pdf

• Authority

  Ministry of Public Health (MoPH)

  Topic

  Ministerial Decision No. 1506/1 of 1 September 2014 — أحكام توضيحية لتطبيق القرار رقم 1/455: implantable device definition (Art. One), GMDN classification and coding (Art. Two), the four risk levels and the EU/US/Japan/Australia/Swiss/Canada class table with Annex 1 (Art. Three), the GHTF/IMDRF free-sale certificate (Art. Four), and the import control date for unrecorded implantables (Art. Six)

  Url

  https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Laws%20and%20Regulations/karar%201506-2014.pdf

• Authority

  Ministry of Public Health (MoPH)

  Topic

  Medical Technology page — the Ministry's register of device instruments (Decision 455 of 16/4/2013, Decision 1506 of 1/9/2014, Decision 1704-1 of 12/9/2017, Decision 181-1 of 30/1/2018) and the MEDRES medical device registration system

  Url

  https://www.moph.gov.lb/en/Pages/3/2275/medical-technology

• Authority

  Ministry of Public Health (MoPH)

  Topic

  list of registered implantable medical devices — the registration of device procedures at the Ministry, the cooperation with the Agence française de sécurité du médicament et des produits de santé (ANSM), and the requirement that implantable devices be registered on the National List of Implantable Medical Devices before first commissioning under a harmonised coding system

  Url

  https://www.moph.gov.lb/en/Pages/4/8262/list-of-registered-implantable-medical-devices-at-moph

• Authority

  Ministry of Public Health (MoPH)

  Topic

  Procédure nationale de réglementation des dispositifs médicaux au Liban, November 2013 (French) — import modalities, supplier declarations, the Health Technology Unit's evaluation steps and the operational procedures still to be drafted

  Url

  https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Medical%20Devices/Reglementation_DM_versionfinale_Nov2013.pdf

• Authority

  Telecommunications Regulatory Authority (TRA)

  Topic

  Type Approval Regulation (Official Gazette Issue 17 of 16 April 2009, Decision 5/2009; Modification Decision 3/2026), the transfer of type-approval issuance to the TRA by Minister of Telecommunications Decision No. 1/624 of 10/11/2025, the Technical Compliance Folder requirements, and the fee schedule of Board Decision No. 9/2025

  Url

  https://www.tra.gov.lb/Type-approval-Regulation

• Authority

  Ministry of Public Health (MoPH)

  Topic

  Ministerial Decision No. 1704/1 of 12 September 2017 — commencement of the computerised invoice-upload system for the entry of implanted medical devices, the duty to keep conformity certificates current, and the stop on stamping invoices not uploaded in the system

  Url

  https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Laws%20and%20Regulations/%D9%82%D8%B1%D8%A7%D8%B1%20%D8%B1%D9%82%D9%85%201704-1%20%D8%AA%D8%A7%D8%B1%D9%8A%D8%AE%2012%20%D8%A7%D9%8A%D9%84%D9%88%D9%84%202017%20%D8%A8%D8%AF%D8%A1%20%D8%A7%D9%84%D8%B9%D9%85%D9%84%20%D8%A8%D9%86%D8%B8%D8%A7%D9%85%20%D8%AA%D8%AD%D9%85%D9%8A%D9%84%20%D9%81%D9%88%D8%A7%D8%AA%D9%8A%D8%B1%20%D8%A7%D8%AF%D8%AE%D8%A7%D9%84%20%D8%A7%D9%84%D9%85%D8%B9%D8%AF%D8%A7%D8%AA%20%D8%A7%D9%84%D8%B7%D8%A8%D9%8A%D8%A9%20%D8%A7%D9%84%D9%85%D8%BA%D8%B1%D9%88%D8%B3%D8%A9.pdf

• Authority

  Ministry of Public Health (MoPH)

  Topic

  Ministerial Decision No. 181/1 of 30 January 2018 — extension to 15 March 2018 of the deadline for registering implanted devices in the computerised registration system, and the stop on stamping invoices not uploaded in the system from 16 March 2018

  Url

  https://www.moph.gov.lb/userfiles/files/HealthCareSystem/Medical%20Technology/Laws%20and%20Regulations/%D9%82%D8%B1%D8%A7%D8%B1181-1%20%D8%AA%D8%A7%D8%B1%D9%8A%D8%AE%202018-1-30.pdf