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Lebanon medical device registration resources

Research Ministry of Public Health registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Lebanon medical device resource.

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Structured regulatory requirements

Explore all 43 source-linked facts

23 of 25 research dimensions currently covered · 11 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified
The MOPH health technology unit is the competent authority for medical-device registration; an inter-departmental committee acts pending its establishment
A health technology unit is established at the Ministry of Public Health to carry out all executive tasks for the evaluation and surveillance of medical technologies including implantable m…
1 source-linked fact
Checked 2026-09-16
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D02

Legal basis & guidance

Verified
Decision No. 1506/1 of 1 September 2014 explains the application of Decision 455/1
Decision No. 1506/1 of 1 September 2014 sets out explanatory provisions for the application of Decision No. 455/1. It defines implantable medical devices (Art. One), classifies and codes de…
Decision No. 455/1 of 16 April 2013 is the statutory basis for medical-device importation and conformity
Decision No. 455/1 of 16 April 2013 regulates the importation and use of medical materials. Article One imposes a conformity certificate on all imported medical equipment, instruments and s…
3 source-linked facts
Checked 2026-09-16
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D03

Device definition & scope

Verified
Accessories are treated as full medical devices and must meet every provision of the procedure
Under the general provisions, accessories of medical devices are treated as medical devices in their own right and must also satisfy all provisions of the national procedure.
Active implantable device and device accessory are defined in the procedure's lexicon
The 2013 national procedure defines an active implantable medical device as any device designed to be totally or partially implanted in the human body or placed in a natural orifice and whi…
3 source-linked facts
Checked 2026-09-16
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D04

Classification rules

Verified
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
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)
1 maintained scheme · 1 related fact
Checked 2026-09-16
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D05

Registration pathways

Verified
Registration with the MOPH health technology unit is required before any sale
Every manufacturer, importer or distributor of medical devices must address an application for registration to the Ministry of Public Health / health technology unit before any placing on s…
1 source-linked fact
Checked 2026-09-16
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D06

Reliance & recognition

Verified
Registration file must carry at least one accepted foreign conformity certificate — FDA, CE, TGA/Health Canada/Japan or IRI
statement: A registration application must be accompanied by at least one of a closed menu of conformity documents: the US FDA approval (510(k) or PMA) or an FDA certificate for foreign gov…
Clinical evaluation is not re-performed in Lebanon; the work of GHTF regulatory authorities is used
statement: The Lebanese assessment of an implantable device does not address the clinical evaluation aspects at all: the MOPH health technology unit explicitly relies on the work already ca…
6 source-linked facts
Checked 2026-09-16
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D07

Economic-operator roles

Verified
Companies importing devices must have a local agent or distributor who registers the devices with the MOPH
Companies wishing to import medical devices must have a local agent or a distributor, and that local agent or distributor must register the devices commercialised with the Ministry of Publi…
Manufacturers, commercial representatives, importers and distributors must declare themselves to the MOPH and hold a manufacturer authorisation per product
Manufacturers with a seat in Lebanon, commercial representatives, importers and distributors must declare themselves to the Ministry of Public Health, communicate the information required f…
2 source-linked facts
Checked 2026-09-16
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D08

Establishment, import & distribution

Verified
Implantable-device import invoices must be uploaded into MED Import before endorsement
By Decision No. 1704/1 of 12 September 2017 the MOPH began mechanising the import invoices for implantable medical devices and applied the MED Import online system from 16 August 2017: all…
A device supplier must be a company on the commercial register, sign a traceability/market-surveillance undertaking, and receives a one-year renewable MOPH authorisation with portal credentials
To declare itself as a supplier of medical devices an establishment must be a company holding a commercial register number and must confirm its commitment to the manufacturers' traceability…
3 source-linked facts
Checked 2026-09-16
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D09

Dossier requirements

Verified
Registration application in two copies with the LNDM sheet and supporting documents in English, French or Arabic
The registration application is drawn up in two copies and must include: (1) the LNDM identification sheet printed by the supplier from the MOPH computerised system, (2) at least one of the…
1 source-linked fact
Checked 2026-09-16
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D10

Official forms & portals

Verified
The LNDMI web-based registration system with MOPH-issued supplier credentials
The MOPH created and maintains a web based registration system with direct download of medical device information: the National List of Implantable Medical Devices (LNDMI). Its purpose is t…
1 source-linked fact
Checked 2026-09-16
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Submission & evidence

D11

Label, IFU & language

Verified
Packaging label must show origin, manufacturer name and address in Arabic, English or French and carry 13 prescribed elements
The label affixed to the packaging must show the country of origin and the manufacturer's name and address in Arabic, English or French, and must carry: the manufacturer's name or business…
1 source-linked fact
Checked 2026-09-16
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D12

QMS, audit & inspection

Verified
QMS is evidenced documentarily by an ISO 13485 certificate, required for non-reference-origin products
Quality system evidence for registration is documentary: a certificate of conformity of the manufacturer's quality management system to ISO 13485, required for products whose countries of o…
1 source-linked fact
Checked 2026-09-16
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D13

Standards, testing & ancillary approvals

Unresolved
TRA type approval for radio and telecommunications terminal equipment
Wireless / radio
Lebanese Atomic Energy Authority approval to import or export a device
Radiation
Industrial Research Institute conformity certificate for imported devices
Product-specific
5 maintained overlays · 3 related facts
Checked 2026-09-16
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Fiscal stamp on the device entry or import approval (form MPH12-26)
LBP 1,000
Fiscal stamp on the sterile medical instruments import application (form MPH212-9)
LBP 1,000
3 maintained fee lines · 1 related fact
Checked 2026-09-16
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D15

Review clocks

Unresolved
Entry and import approval for medical devices, instruments and supplies of all risk levels — form MPH12-26 · 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
7-14 days
1 maintained pathway · 1 related fact
Checked 2026-09-16
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D16

Approval validity & renewal

Verified
The device registration certificate is valid for five years and renewable on request
The Ministry of Public Health issues the registration certificate on the basis of the opinion of the health technology unit; it is valid for five years and renewable on request of the benef…
1 source-linked fact
Checked 2026-09-16
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Lifecycle & post-market

D17

Change control

Verified
Modifications run through a modification dossier; conformity certificates must be kept current or imports are blocked
Registration modifications are handled as their own dossier type: the health technology unit processes registration, renewal, modification and withdrawal dossiers (§7.2.2 list item 2), and…
1 source-linked fact
Checked 2026-09-16
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D18

UDI, listing & traceability

Verified
Devices are identified with GMDN coding and a unique national code communicated to customs
Medical devices must be identified according to the list established by the MOPH, which is based on the GMDN coding system; a unique code is assigned to every device appearing on the LNMDI…
Supplier and hospital traceability registers, with a patient information sheet on discharge
For post market surveillance and traceability of devices placed on the market, registers must be kept by suppliers and by users (public and private care establishments). The supplier must k…
2 source-linked facts
Checked 2026-09-16
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D19

Clinical investigation & performance

Verified
A device intended for clinical investigation must carry the label mention « exclusivement pour investigations cliniques »
Among the label indications the registration dossier must show, the procedure requires, for a device intended for clinical investigations, the mention 'exclusively for clinical investigatio…
1 source-linked fact
Checked 2026-09-16
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D20

Special access & derogation

Verified
Dedicated dossier track for devices subject to special conditions: transplant tissues, animal-origin components, coronary stents
The registration process provides for the evaluation of registration dossiers for medical devices subject to special conditions, naming tissues dedicated to transplantation, medical devices…
1 source-linked fact
Checked 2026-09-16
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D21

Manufacturer PMS

Verified
The MOPH may block or cancel the supplier's authorisation for failure to honour post-market obligations
The Ministry of Health has the right to block the authorisation it has granted to a supplier and even to cancel it where the supplier does not honour its obligations in the post commerciali…
Supplier must specify storage, transport, installation and maintenance measures and train users
Together with the registration documents for every product it intends to place on the Lebanese market, the manufacturer or its commercial representative must communicate any information or…
2 source-linked facts
Checked 2026-09-16
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D22

Vigilance & incident reporting

Verified
MOPH relays alerts to patients and users, including alerts from GHTF member-country competent authorities
The MOPH must warn patients, users or any other concerned party when it becomes aware of an alert relating to a medical device that puts public health or patient safety at risk. The informa…
Manufacturer or commercial representative must report every adverse event to the MOPH
The manufacturer, or its commercial representative, must report any adverse event to the Ministry of Public Health for every product it intends to place on the Lebanese market.
2 source-linked facts
Checked 2026-09-16
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D23

Recall, FSCA & market surveillance

Verified
MOPH may suspend or cancel the LNDMI registration and withdraw the device from the market
Where the MOPH detects fraud or misleading information supplied by a supplier or any party in the medical device supply chain, it reserves the right to carry out the necessary investigation…
1 source-linked fact
Checked 2026-09-16
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D24

Advertising, claims & promotion

Verified
Advertising medical devices not declared to the MOPH is prohibited; advertising must not mislead
Advertising for medical devices that have not been declared to the Ministry of Public Health is prohibited. Advertising material must not mislead the user as to the performance of the medic…
1 source-linked fact
Checked 2026-09-16
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D25

Submission communications & appeal

Verified
The health technology unit issues an opinion; the Minister of Health issues the final decision
Once the assessment of the file is complete the health technology unit issues an opinion based on the information supplied and on its findings, which is transmitted to the Minister of Healt…
Refusal, provisional suspension or withdrawal of the registration certificate, with a 60-day period to regularise
The Ministry of Public Health may, on the report of the health technology unit, refuse, provisionally suspend or withdraw the registration certificate of the medical device concerned. The h…
2 source-linked facts
Checked 2026-09-16
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Ministry of Public Health registration fees in LBP · reviewed 2026-09-16

Fee lineAmountProvenance
Fiscal stamp on the device entry or import approval (form MPH12-26)LBP 1,000Verified
Fiscal stamp on the sterile medical instruments import application (form MPH212-9)LBP 1,000Verified
Fiscal stamp on the medical or laboratory reagents import application (form MPH212-3)LBP 1,000Verified

Registration timeline

Full registration timeline

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) review clocks and planning ranges · 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 classification

Class / pathwayReview clockPlanning totalProvenance
Entry and import approval for medical devices, instruments and supplies of all risk levels — form MPH12-26(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)7-14 days1-2 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(7-14 days)
  5. 5Registration Approval(1-2 weeks)

Official Ministry of Public Health rules and guidance · 1 of 1 documents linked to official sources

Version 1 – Novembre 2013Procédure nationale de réglementation des dispositifs médicaux au Liban : modalités d’importation, déclaration des fournisseurs, évaluation des DM
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