Ministry of Public Health · structured requirements

🇱🇧 Lebanon medical device regulatory data

Explore the medical device requirements currently available for Lebanon, organized by topic and linked to official sources.

43 facts25 dimensions4 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Advertising medical devices not declared to the MOPH is prohibited; advertising must not mislead

advertising.prohibited-for-devices-not-declared-to-moph

Fact-level verified

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 medical device as specified by the manufacturer.

Conditions

Declaration to the MOPH is the gate: the prohibition bites on undeclared devices, so the local supplier declaration and device registration are what unlock promotion.
No pre-approval of advertising copy by the MOPH is provided for in the procedure.

Effective from 2013-11-01

Source language French. Original: "13. La publicité pour des dispositifs médicaux non déclarés au MSP est interdite. 14. Le matériel publicitaire ne doit pas induire en erreur l'utilisateur concernant les performances du dispositif médical tel qu'elles sont spécifiées par le fabricant." Translation of the excerpt: "Advertising for medical devices not declared to the MOPH is prohibited." Translation of provision 14: "Advertising material must not mislead the user concerning the performance of the medical device as specified by the manufacturer."

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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The device registration certificate is valid for five years and renewable on request

renewal.registration-certificate-valid-five-years

Fact-level verified

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 beneficiary. Renewal dossiers are processed alongside registration, modification and withdrawal dossiers by the health technology unit.

Conditions

The five-year validity applies to the medical-device registration certificate issued on the unit's opinion.
The supplier's own authorisation from the MOPH is separate and is granted for one renewable year.
No fee for renewal is set in the procedure.
The procedure's step is numbered "7. Contestation du fournisseur" in the source, but its content is the certificate validity, refusal, suspension and withdrawal rule.

Effective from 2013-11-01

Source language French. Original: "Le Ministère de la Santé Publique délivre le certificat d'enregistrement, valable pour 5 ans renouvelable sur demande du bénéficiaire, sur la base de l'avis de l'unité des technologies de la santé." Translation: "The Ministry of Public Health issues the registration certificate, valid for 5 years and renewable on request of the beneficiary, on the basis of the opinion of the health technology unit."

Authority & regime

Which authority and binding regime govern this product, task, and date?

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The MOPH health technology unit is the competent authority for medical-device registration; an inter-departmental committee acts pending its establishment

authority.moph-health-technology-unit-is-device-authority

Fact-level verified

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 medical devices. Pending its creation, a commission composed of staff in charge of the pharmacy departments (import/export service) and sanitary engineering at the MOPH is responsible for executing the terms of the procedure. The unit's tasks include evaluating medical technologies, adopting national standards for placing devices on the market, deploying supplier and device registration procedures, and setting up and following the post-market surveillance system.

Conditions

The unit works with the national stakeholders named in the procedure: the National Council for Scientific Research / National Atomic Energy Commission, the Lebanese Order of Dentists, the Ministry of Finance / Directorate General of Customs, and the syndicate of importers and traders of medical equipment and laboratory reagents.
LIBNOR (the Lebanese standards institute) has adopted European medical-device standards as national standards and works to make them mandatory by publishing the corresponding decrees.
The Minister of Health issues the final registration decision on the health technology unit's opinion; the import-endorsement and implantable-registration functions sit with the Programs and Projects department and the pharmacy and sanitary-engineering services.

Effective from 2013-11-01

Source language French. Original: "Il est créé au Ministère de la santé publique une unité des technologies de la santé qui prendra en charge toutes les tâches exécutives pour l'évaluation et la surveillance des technologies médicales y compris les dispositifs médicaux implantables afin d'assurer la sécurité de leur utilisation." and "Provisoirement, dans l'attente de la création de cette unité, une commission composée du personnel en charge dans les départements de pharmacie (service import/export) et de génie sanitaire au MSP sera responsable de l'exécution des termes de cette procédure." Translation: "A health technology unit is created at the Ministry of Public Health which will take charge of all executive tasks for the evaluation and surveillance of medical technologies including implantable medical devices in order to ensure the safety of their use." / "Provisionally, pending the creation of this unit, a commission composed of the staff in charge in the pharmacy departments (import/export service) and sanitary engineering at the MOPH will be responsible for executing the terms of this procedure."

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Modifications run through a modification dossier; conformity certificates must be kept current or imports are blocked

change-control.modification-dossier-and-certificate-currency

Fact-level verified

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 the supplier must inform the MOPH of any change or modification to the information given at registration and keep that information updated (§6.2 provision 21). Under Decision No. 1704/1 of 12 September 2017, Article Three, importers and distributors must also keep the conformity certificates of the devices recorded in the MEDREG system up to date, failing which the MED Import system refuses invoices for items whose certificates have expired.

Conditions

The supplier's declared information must be updated annually, and the supplier register is updated on an annual basis by the MOPH (§6.1 provision 5a; §6.2 provision 22).
A change of the commercialisation authorisation between manufacturer and supplier must be notified to the MOPH, and the newly authorised supplier must declare itself (§6.2 provision 19).
Non-compliance with post-market obligations entitles the MOPH to block and even cancel the supplier's authorisation (§6.2 provision 23).

Effective from 2013-11-01

Source language French. Original (7.2.2 list item 2): "Evaluation et traitement des dossiers d'enregistrement, de renouvellement, modification ou retrait" and (provision 21) "Le fournisseur est responsable de: Fournir l'information nécessaire à la déclaration des fournisseurs et assurer sa mise à jour. Informer le MSP de tout changement ou modification des informations fournies lors de l'enregistrement." Translation: "Evaluation and processing of registration, renewal, modification or withdrawal dossiers" / "The supplier is responsible for: supplying the information necessary for the supplier declaration and ensuring it is kept up to date. Informing the MOPH of any change or modification of the information supplied at registration."

Classification rules

What local class follows from which rules and decisive product facts?

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Risk classification is taken from the reference jurisdictions rather than being a standalone Lebanese classification

classification.risk-class-table-mapped-to-reference-jurisdictions

Fact-level verified

Decision No. 1506/1 of 1 September 2014, Article Three, classifies devices by level of risk according to a table mapped across the classification systems of the European Union, the United States, Japan, Australia, Switzerland and Canada: 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, (no US entry), Japan III, Australia II-b, Swiss II-b, Canada III; High = EU III, US III, Japan IV, Australia III, Swiss III, Canada IV. Article Two classifies and codes devices under the globally adopted GMDN nomenclature; the November 2013 procedure assigns a unique national code to each device on the LNMDI list.

Conditions

Annex 1 attaches the accepted European conformity documents to the class (III: Doc.1+Doc.2; IIb: Doc.1 or Doc.3+Doc.4+Doc.5; IIa: Doc.3+Doc.4+Doc.5 or Doc.1; I: Doc.7).
The November 2013 national procedure itself contains no separate Lebanese classification rule; the classes come from the reference systems.
The GMDN-based identification and unique national code are recorded separately under udi.gmdn-coding-and-unique-national-code.

Effective from 2014-02-18

Source language Arabic; scanned PDF recovered by OCR, tables only partially legible — source-backed-partial. The classification table under Article Three (المادة الثالثة) presents device classes against the EU, US, Japan, Australia, Switzerland and Canada systems, but the OCR does not render its columns reliably, so only the existence and cross-jurisdiction character of the table is asserted.

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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A device intended for clinical investigation must carry the label mention « exclusivement pour investigations cliniques »

clinical.investigational-device-label-mention

Fact-level verified

Among the label indications the registration dossier must show, the procedure requires, for a device intended for clinical investigations, the mention 'exclusively for clinical investigations'.

Conditions

Label element list of the registration dossier (7.2.1 item 3, sub-item h).

Effective from 2013-11-01

Source language French. Translation: 'h. if the device is intended for clinical investigations, the mention "exclusively for clinical investigations".'

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Accessories are treated as full medical devices and must meet every provision of the procedure

definition.accessories-are-devices-in-their-own-right

Fact-level verified

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.

Effective from 2013-11-01

Source language French. Translation: 'Accessories of medical devices are treated as medical devices in their own right and must also satisfy all the provisions of this procedure.'

Active implantable device and device accessory are defined in the procedure's lexicon

definition.active-implantable-device-and-accessory-defined

Fact-level verified

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 which depends for its functioning on an electrical or other energy source other than that generated directly by the human body or gravity, and a device accessory as any article intended principally by its manufacturer to be used with a medical device.

Conditions

Definitions apply 'au sens de la présente procédure' (Lexique, section 1).

Effective from 2013-11-01

Source language French. The two definitions are laid out in a two-column table; the label and text of each are joined here. Complements the existing definition fact, which carries the general device definition (by reference to French CSP art. L.5211-1) and the exclusion of human-origin components.

The procedure groups devices into five families: active implantables, IVDs, custom-made, disability-compensation and all other devices

definition.five-device-families-including-ivd-and-custom-made

Fact-level verified

The procedure states that medical devices are organised in five large families: (1) active implantable medical devices, e.g. pacemakers; (2) in vitro diagnostic medical devices, e.g. trisomy tests; (3) custom-made devices, e.g. dental prostheses; (4) devices intended to compensate a disability, e.g. hearing aids; and (5) all other devices, subdivided into non-active implants, equipment (MRI, scanner, ventilators), consumables and device accessories, the latter being treated as devices. It also notes the spread of combined devices incorporating a medicinal substance, such as drug-eluting coronary stents.

Conditions

The operative registration and import rules of the same procedure are stated for implantable devices and their accessories (section 4); the family list is descriptive.

Effective from 2013-11-01

Source language French. English gist in the value. This is the only place in Lebanon's device instruments where IVDs are named as a device family.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Registration application in two copies with the LNDM sheet and supporting documents in English, French or Arabic

dossier.submission-set-and-document-language

Fact-level verified

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 accepted conformity documents, (3) the packaging label, (4) the device's user manual and (5) the manufacturer's invoice. All documents required by the procedure must be supplied in one of three languages: English, French or Arabic.

Conditions

No proof of payment and no separate manufacturer's declaration of conformity beyond what the conformity menu requires is listed; the file consists of the five numbered items.
The dossier is deposited with the health technology unit (implantable-device registration dossiers).
The supplier dossier for the supplier declaration itself is a separate filing containing the applicant's capacity, its activity description and device categories, company and legal-representative contact details, the manufacturers it represents where it is an importer or distributor, and the submission date.

Effective from 2013-11-01

Source language French. Original (provision 6): "Tous les documents exigés par la présente procédure doivent être fournis dans l'une des trois langues : Anglais, Français ou Arabe." and (7.2.1 item 1) "Fiche d'identification d'un dispositif médical imprimé par le fournisseur après la saisie du produit sur le système informatisé du MSP (identification par code fiche)(LNDM)." and "Cette demande, établie en 2 exemplaires, doit inclure les documents suivants". Translation: "All documents required by this procedure must be supplied in one of three languages: English, French or Arabic." / "Medical-device identification sheet printed by the supplier after entering the product in the MOPH computerised system (identification by sheet code) (LNDM)." / "This application, drawn up in 2 copies, must include the following documents".

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Companies importing devices must have a local agent or distributor who registers the devices with the MOPH

operators.local-agent-or-distributor-must-register-devices

Fact-level verified

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 Public Health. The application for registration is addressed by the manufacturer, importer or distributor to the MOPH health technology unit.

Conditions

The local actor is the applicant of record for registration of the devices it commercialises.
The local agent or distributor must itself be declared to the MOPH as a supplier before its first import operation.
The manufacturer's authorisation for the distributor to commercialise the products on the Lebanese market is a required document in every registration file.

Effective from 2013-11-01

Source language French. Original: "Les sociétés qui souhaitent importer des DM doivent avoir un agent local ou un distributeur qui doit enregistrer les dispositifs médicaux commercialisés auprès du MSP." Translation: "Companies wishing to import medical devices must have a local agent or a distributor who must register the medical devices commercialised with the MOPH."

Manufacturers, commercial representatives, importers and distributors must declare themselves to the MOPH and hold a manufacturer authorisation per product

operators.supplier-declaration-and-manufacturer-authorisation-per-product

Fact-level verified

Manufacturers with a seat in Lebanon, commercial representatives, importers and distributors must declare themselves to the Ministry of Public Health, communicate the information required for registering the products they commercialise, and hold an authorisation from the manufacturer for each product introduced and commercialised on the local market. Supplier declaration is a precondition of a first import operation, and the MOPH assigns each declared supplier a username and password for the online device-registration system. The MOPH authorisation given to the supplier is granted for one renewable year.

Conditions

A manufacturer with a seat in Lebanon may itself be considered an importer and/or a distributor.
Supplier declaration includes a commercial-register number and a signed undertaking to take part in the traceability protocols run by manufacturers and in the market-surveillance system for products already in service.
The supplier must notify the MOPH of any termination of a commercialisation authorisation concluded between manufacturer and supplier, and the newly authorised supplier must also declare itself.
The supplier is responsible for keeping the declared information up to date and for informing the MOPH of any change or modification to the information provided at registration.

Effective from 2013-11-01

Source language French. Original (section 6.1 provision 3): "Les fabricants ayant un siège au Liban, les représentants commerciaux, les importateurs et les distributeurs doivent: Se déclarer au Ministère de la santé publique. Communiquer les informations requises pour l'enregistrement des produits qu'ils commercialisent. Avoir une autorisation du fabricant pour chaque produit introduit et commercialisé sur le marché local" and (provision 18) "L'autorisation du MSP est donnée pour un an renouvelable." Translation: "Manufacturers with a seat in Lebanon, commercial representatives, importers and distributors must: declare themselves to the Ministry of Public Health; communicate the information required for registering the products they commercialise; hold an authorisation from the manufacturer for each product introduced and commercialised on the local market." / "The MOPH authorisation is given for one renewable year."

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Implantable-device import invoices must be uploaded into MED Import before endorsement

establishment.medimport-invoice-upload-conditions-import-endorsement

Fact-level verified

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 importers and distributors must upload the import invoices for these devices directly through the system, after confirming that every implantable item on the invoice is recorded with the Programs and Projects department. From 1 December 2017 the import department of the pharmacy service and the Health Engineering Service stop endorsing invoices that have not been uploaded into Med Import. Importers and distributors must also keep the conformity certificates of the devices recorded in the MEDREG registration system up to date, failing which Med Import refuses invoices for items whose certificates have expired.

Conditions

The invoice data to be uploaded includes the importing company number, the invoice date and number, the catalogue number, the supplying company number, the customs declaration number, the device name and type, the currency, the quantity/price and the lot number (Art. Four).
Where an invoice contains both sterile and non-sterile items, endorsement starts with the import department in the pharmacy service and continues with the Health Engineering Service within its own remit (Art. Two).
Decision 181/1 of 30 January 2018 extended to 15 March 2018 the deadline for importers that had not finished registering their implantable devices in MedReg, and the endorsement stop applies from 16 March 2018 (Arts. One and Three).
The MOPH runs periodic training sessions on the Med Import system (Art. Five).

Effective from 2017-12-01

Source language Arabic; scanned PDF recovered by OCR (pdftoppm + tesseract -l ara+eng), digits unreliable — source-backed-partial. OCR original (Article One): "تباشر وزارة الصحة العامة بمكننة فواتير استيراد المعدات الطبية المغروسة وتباشر اعتبارا من 16 آب 2017 بتطبيق نظام تحميل فواتير الاستيراد MED Import online system؛ لذلك، يطلب من جميع المستوردين والموزعين تحميل فواتير استيراد هذه المعدات مباشرة عبر هذا النظام بعد التأكد من ان كافة الاصناف المغروسة الواردة فيها هي مدونة في دائرة البرامج والمشاريع." Translation: "The Ministry of Public Health begins the mechanisation of import invoices for implantable medical equipment and, with effect from 16 August 2017, applies the MED Import online system; accordingly all importers and distributors are required to upload the import invoices for these devices directly through this system after confirming that all the implantable items appearing in them are recorded with the Programs and Projects department." Article Three OCR: "يطلب من الشركات المستوردة والموزعة متابعة تحديث شهادات المطابقة للاجهزة والادوات المدونة في نظام التسجيل MEDREG تحت طائلة رفض نظام MED Import لتحميل فواتير المواد ذات الشهادات المنتهية". Article Six (Decision 1704/2017): endorsement stops from 1 December 2017. Decision 181/1 OCR confirms the MedReg system and the 15 March 2018 deadline plus the 16 March 2018 stop date.

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

establishment.supplier-declaration-conditions-and-one-year-renewable-authorisation

Fact-level verified

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 protocols and its involvement in market surveillance of products already in service by signing a consent. The MOPH assigns each declared supplier a user identifier and password giving access to the online device-registration system, and the MOPH authorisation is given for one year, renewable.

Conditions

A newly established supplier must complete the declaration before its first import operation and update it annually (6.1 provision 5).
The MOPH may block or cancel the authorisation where the supplier does not honour its post-market obligations (6.2 provision 23, already recorded under manufacturer-pms).

Effective from 2013-11-01

Source language French. Provision 16 (intervening, elided) lists the proof documents: manufacturer authorisation, labelling/storage/transport per manufacturer conditions, traceability. The existing economic-operator fact covers the obligation to declare; this fact adds the eligibility conditions, the credentials and the one-year validity.

The supplier-declaration dossier comprises the declaration sheet, a commercial-register certificate and a signed traceability/market-surveillance consent

establishment.supplier-declaration-dossier-three-documents

Fact-level verified

The supplier-declaration dossier filed with the MOPH must contain: (1) the supplier-declaration sheet with the administrative data (whether the applicant is manufacturer, importer or distributor; activities and device categories marketed; company and legal-representative contact details; for importers/distributors, the represented manufacturers and their contacts); (2) a certificate proving the supplier's registration on the Lebanese commercial register showing its principal activities; and (3) a consent signed by the supplier confirming adherence to the manufacturers' traceability protocols, involvement in market surveillance of marketed products and commitment to communicate any information relevant to safe use. Incomplete dossiers draw a request for complements with a response deadline; after data entry the supplier receives credentials for tele-declaration of its products, and the access code changes at each annual renewal.

Conditions

The declaration form ('Déclaration des fournisseurs – fiche de collecte d'information') is annexed to the procedure (pp. 36–37).

Effective from 2013-11-01

Source language French; sub-items a–e of item 1 elided in the excerpt.

Fees

What regulator fee applies to this class, route, event, and date?

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Import-permit charge under Law No. 193 of 18 November 2011 is payable to the physicians’ syndicate

fees.import-permit-fee-imposed-by-law-197

Fact-level verified

The Health Engineering Service (مصلحة الهندسة الصحية) of the MOPH grants entry permits after verifying that the legal conditions are met, in particular the conformity certificate issued by the Industrial Research Institute, and after payment of the charge imposed by Law No. 193 of 18 November 2011 (amending certain provisions of the retirement-fund law of each of the Beirut and Tripoli physicians' syndicates), payable to the physicians' syndicate in accordance with joint decision No. 180/1 of 15 February 2012 of the Ministers of Public Health and Finance. The competent ministry departments do not endorse customs declarations unless the declaration is accompanied by those documents.

Conditions

No medical-device registration fee schedule is set in the 2013 national procedure or in Decisions 455/1, 1506/1, 1704/1 or 181/1; the only fixed charge published on the device import applications is the LBP 1,000 fiscal stamp on the MoPH service records.
The fee described here attaches to the import permit and customs-declaration endorsement, not to the registration application itself.

Effective from 2013-07-01

Official Decision 455/1 scan visually rechecked, page 2, Articles Three, Four and Six. Article Four cites Law No. 193 of 18 November 2011 and joint decision No. 180/1 of 15 February 2012. Earlier OCR misread those numbers; the scan controls. No fee amount is asserted.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Packaging label must show origin, manufacturer name and address in Arabic, English or French and carry 13 prescribed elements

label.packaging-label-elements-and-language

Fact-level verified

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 name and address; the indications strictly necessary for the user to identify the device and the contents of the packaging; where applicable the word "sterile"; where applicable the lot code preceded by the word "lot" or the serial number; where applicable the date until which the device can be safely used, expressed as year and month; where applicable an indication that the device is for single use; for a custom-made device the words "custom-made device"; for a device intended for clinical investigations the words "exclusively for clinical investigations"; particular storage and/or handling conditions; particular instructions for use; warnings and/or precautions to be taken; the year and month of manufacture for active devices not covered by the expiry indication; and where applicable the sterilisation method.

Conditions

The label text and content must take account of the qualifications of the users and of the device's end use.
Alteration, mutilation, destruction, obliteration or removal of one or more parts of the labelling may lead to refusal of registration of the device on the LNDMI.
The label must be supplied as a copy with the registration file; the procedure does not require a Lebanese-Arabic-only label, since Arabic, English and French are all accepted.
The user manual must be provided with the registration file and must contain the prescribed indications, including whether the device is to be installed with other devices, and it must accompany the device.

Effective from 2013-11-01

Source language French. Original (item 3 opening): "L'étiquette collée sur l'emballage et montrant le pays d'origine, le nom et l'adresse du fabricant (en Arabe, anglais ou français), doit comporter les indications suivantes : a. le nom ou la raison sociale et l'adresse du fabricant; b. les indications strictement nécessaires à l'utilisateur pour identifier le dispositif et le contenu de l'emballage; c. le cas échéant la mention « stérile »; d. le cas échéant le code du lot précédé par la mention « lot » ou le numéro de série; e. le cas échéant la date jusqu'à laquelle le dispositif peut être utilisé en toute sécurité, exprimée par l'année et le mois; f. le cas échéant, une indication précisant que le dispositif est destiné à un usage unique; g. s'il s'agit d'un dispositif sur mesure, la mention « dispositif sur mesure »; h. s'il s'agit d'un dispositif destiné à des investigations cliniques, la mention « exclusivement pour investigations cliniques »; i. les conditions particulières de stockage et/ou de manutention; j. les instructions particulières d'utilisation; k. les mises en garde et/ou les précautions à prendre; l. l'année et le mois de fabrication pour les dispositifs actifs, autres que ceux couverts par le point e; m. le cas échéant, la méthode de stérilisation." and (provision 28) "l'altération, la mutilation, la destruction, l'oblitération ou la suppression d'une ou plusieurs parties de l'étiquetage pourrait mener au refus de l'enregistrement du DM sur la LNDMI." Translation: "The label affixed to the packaging and showing the country of origin, the name and address of the manufacturer (in Arabic, English or French), must contain the following indications …" / "the alteration, mutilation, destruction, obliteration or removal of one or more parts of the labelling could lead to refusal of registration of the medical device on the LNDMI."

Legal basis & guidance

Which current law, regulation, guidance, and transition provisions apply?

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Decision No. 1506/1 of 1 September 2014 explains the application of Decision 455/1

legal-basis.moph-decision-1506-of-2014-explanatory-rules

Fact-level verified

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 devices under GMDN (Art. Two), classifies devices by risk level in a table mapped across the EU, US, Japan, Australia, Switzerland and Canada with Annex 1 listing the accepted European conformity documents by class (Art. Three), adds a mandatory IMDRF free sale certificate or certificate for foreign government to the registration documents (Art. Four), adopts the amended DMI-02 identification card (Art. Five) and stops customs endorsement of imported implantables not recorded with the Programs and Projects department from 1 April 2015 (Art. Six).

Conditions

Read with the November 2013 national procedure, which is the operative guideline implementing both decisions.
Annex 1 (legible): Class III = Doc.1+Doc.2; IIb = Doc.1 or Doc.3+Doc.4+Doc.5; IIa = Doc.3+Doc.4+Doc.5 or Doc.1; I = Doc.7.

Effective from 2014-02-18

Source language Arabic; scanned PDF recovered by OCR, digits and tables unreliable — source-backed-partial. Legible OCR anchors: "المادة الرابعة: إضافة الى المستندات المطلوبة في المادة السادسة من القرار رقم 1/455 تاريخ 2013/4/16، يرفق بطلب التسجيل شهادة بيع حر Free sale certificate أو certificate for foreign government…" and "المادة السادسة" (Article Six) barring unregistered imported implantable devices from 1 April 2015. Article Three's risk-class table is present but the OCR renders its columns imperfectly, so no class-to-risk mapping is asserted here.

Decision No. 455/1 of 16 April 2013 is the statutory basis for medical-device importation and conformity

legal-basis.moph-decision-455-1-of-2013

Fact-level verified

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 supplies, adopting mandatory Lebanese standards where they exist and, where they do not, the non-mandatory Lebanese standards or the requirements issued by the European Union or one of the United States of America, Canada, Japan and Australia.

Conditions

Published in the Official Gazette and effective from 1 July 2013 (Article Ten, legible on the scan: 'ويعمل به ابتداء من اول تموز ٢٠١٣').
Supplemented by Decision No. 1506/1 of 1 September 2014 (explanatory provisions).
The conformity certificate is issued by the Industrial Research Institute (Article Three) and the entry permit is granted by the Health Engineering Service after verifying it and payment of the Law No. 193 charge (Article Four).

Effective from 2013-07-01

Source language Arabic; scanned PDF recovered by OCR, digits unreliable — source-backed-partial. OCR original (Article One): "يفرض على جميع التجهيزات والادوات واللوازم الطبية المستوردة شهادة مطابقة. تعتمد في هذا السبيل المواصفات اللبنانية الالزامية عند وجودها وفي حال عدم وجودها تعتمد المواصفات اللبنانية غير الالزامية او الشروط (Exigences — Requirements) الصادرة عن الاتحاد الاوروبي او احدى الدول التالية: الولايات المتحدة الاميركية - كندا - اليابان - استراليا." Translation: "A certificate of conformity is imposed on all imported medical equipment, instruments and supplies. For this purpose, mandatory Lebanese specifications are adopted where they exist, and where they do not exist the non-mandatory Lebanese specifications or the requirements issued by the European Union or one of the following countries are adopted: the United States of America, Canada, Japan, Australia." Article Ten OCR: "ينشر هذا القرار في الجريدة الرسمية ويعمل به ابتداء من اول تموز ..." (published in the Official Gazette and effective from the first of July …).

The November 2013 national procedure is the operative Lebanese guideline implemented by the MOPH health technology unit

legal-basis.national-device-regulation-procedure-2013

Fact-level verified

The National Procedure for the Regulation of Medical Devices in Lebanon, Version 1 of November 2013, lays down the requirements and conditions for importing medical devices together with the qualifications required of suppliers. It is structured as Part 1 (importation of medical devices) and Part 2 (filing and processing of operator declarations and device registrations), and it states the MOPH's regulatory strategy of guaranteeing conformity to international standards while optimising the use of available resources.

Conditions

Part 2 states the strategy expressly: the MOPH follows an approach that prioritises strengthening the regulatory framework by favouring quality and safety through conformity with international standards.
In force today: the MOPH continues to publish it as the medical-device guideline alongside Decisions 455/1, 1506/2014, 1704/1 and 181/1.
Source language is French; Arabic, English and French are all accepted for the documents required by the procedure (section 6.1 provision 6).

Effective from 2013-11-01

Source language French. Original: "Dans le domaine de la réglementation des dispositifs médicaux, le Ministère de la Santé (MSP) suit une stratégie qui respecte ses capacités et les moyens disponibles tout en garantissant le niveau minimal de sécurité des patients et de protection de la santé publique; Elle adopte une approche qui privilégie le renforcement du cadre réglementaire en favorisant la qualité et la sécurité en garantissant la conformité aux standards internationales." Translation: "In the field of medical-device regulation, the Ministry of Health follows a strategy that respects its capacities and the resources available while guaranteeing the minimum level of patient safety and public-health protection; it adopts an approach that privileges strengthening the regulatory framework by favouring quality and safety through guaranteeing conformity to international standards."

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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The MOPH may block or cancel the supplier's authorisation for failure to honour post-market obligations

pms.supplier-authorisation-can-be-blocked-or-cancelled

Fact-level verified

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-commercialisation phase.

Conditions

This is the enforcement lever over the local supplier, separate from the device registration certificate suspension and withdrawal power.
The supplier must report any adverse event to the MOPH, keep its declared information up to date, and take part in traceability and market-surveillance activity.

Effective from 2013-11-01

Source language French. Original: "Le Ministère de la Santé aura le droit de bloquer son autorisation donnée au fournisseur et même l'annuler au cas où il n'honore pas ses obligations dans la phase post-commercialisation." Translation: "The Ministry of Health will have the right to block the authorisation given to the supplier and even to cancel it in the case where it does not honour its obligations in the post-commercialisation phase."

Supplier must specify storage, transport, installation and maintenance measures and train users

pms.supplier-post-market-obligations

Fact-level verified

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 measure taken to accommodate environmental or use conditions specific to the local market, and must specify the measures to be taken to ensure that medical devices are stored, transported, installed and maintained and that users are trained in their use.

Conditions

The supplier must confirm its commitment to the traceability protocols run by manufacturers and be involved in the market-surveillance system for products already in service.
The supplier must keep a register of the medical devices it has placed on the market (see udi.supplier-and-hospital-traceability-registers).
The MOPH reserves the right to conduct the necessary investigations and take appropriate action where it detects fraud or misleading information from a supplier or any party in the device supply chain.

Effective from 2013-11-01

Source language French. Original: "Communiquer toute information ou mesure prise pour accommoder les conditions environnementales ou d'utilisation spécifiques rencontrées sur le marché local. Spécifier les mesures à prendre pour assurer que les dispositifs médicaux sont stockés, transportés, installés et maintenus et les utilisateurs sont formés à leur utilisation. Reporter au MSP tout événement indésirable." Translation: "Communicate any information or measure taken to accommodate the environmental or use conditions specific to the local market. Specify the measures to be taken to ensure that medical devices are stored, transported, installed and maintained and that users are trained in their use. Report any adverse event to the MOPH."

Official forms & portals

Which current form, portal, account, and submission package must be used?

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The LNDMI web-based registration system with MOPH-issued supplier credentials

forms.lndmi-web-based-registration-system

Fact-level verified

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 to collect and update information on the companies commercialising medical devices (manufacturers, commercial representatives, importers, distributors) and to establish the market profile of implantable devices. The MOPH assigns a username and password to each declared supplier so it can access the online device-registration system, and the identification sheet printed from that system must be attached to the registration application.

Conditions

The LNDMI is publicly accessible for consultation in order to strengthen the traceability of declared devices.
The supplier downloads the information about each device directly into the system using the credentials issued by the MOPH; the system prints one identification sheet per device, which must compulsorily accompany the registration application.
Each registration application receives its own reception order number, used as the common reference for all subsequent exchanges between the applicant and the MOPH.

Effective from 2013-11-01

Source language French. Original (provision 25): "Le MSP a créé et assure la maintenance d'un système d'enregistrement avec possibilité de téléchargement direct (web-based) des informations relatives aux DM: la Liste Nationale des Dispositifs Médicaux Implantables LNDMI." and (7.2.2 step 1) "Le fournisseur doit télécharger les informations relatives aux dispositifs médicaux directement sur le système mis en ligne à cette fin en utilisant les identifiants qui lui ont été attribués par le MSP. Ce système permet d'imprimer une fiche d'identification par dispositif qui doit obligatoirement être jointe à la demande d'enregistrement." Translation: "The MOPH has created and maintains a web-based registration system with direct download capability for medical-device information: the National List of Implantable Medical Devices (LNDMI)." / "The supplier must download the information relating to the medical devices directly into the system put online for this purpose, using the credentials assigned to it by the MOPH. This system prints an identification sheet for each device which must compulsorily be attached to the registration application."

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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QMS is evidenced documentarily by an ISO 13485 certificate, required for non-reference-origin products

qms.iso-13485-certificate-is-documentary-qms-evidence

Fact-level verified

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 origin are other than the European Union, the USA, Canada, Australia and Japan, and accepted alongside certified conformity for reference-origin products. The procedure provides no manufacturing-site audit or inspection of the device manufacturer as part of registration; the unit's check is the coherence and authenticity of the documents supplied.

Conditions

Where resources are allocated, the unit performs a sampling verification chosen on the importance and criticality of the device, its safety and the manufacturer's history.
The unit evaluates the quality data supplied and their conformity to international standards, and verifies the quality and authenticity of the documents provided (section 7.2.2 step 4).
Where the device is manufactured in Lebanon or comes from a country outside the reference list, the Industrial Research Institute may certify conformity to Lebanese or reference international specifications instead.

Effective from 2013-11-01

Source language French. Original: "Un certificat de conformité à la norme ISO 13485 du système de gestion de la qualité du fabricant pour les produits dont les pays d'origine sont autres que l'Union Européenne, USA, Canada, Australie et Japon." and (7.2.2 step 4) "Dans le cadre de l'évaluation d'un dossier d'enregistrement d'un dispositif médical, l'unité des technologies de la santé considérera les aspects suivants: Vérifier la cohérence des informations fournies dans le dossier avec celles téléchargées dans la base de données par le fournisseur. Evaluer les données fournies relatives à la qualité et leur conformité aux normes internationales, Vérifier la qualité et l'authenticité des documents fournis." Translation: "A certificate of conformity to the ISO 13485 standard for the manufacturer's quality management system, for products whose countries of origin are other than the European Union, USA, Canada, Australia and Japan." / "In the framework of the assessment of a medical-device registration file, the health technology unit will consider the following aspects: verify the coherence of the information supplied in the file with that downloaded into the database by the supplier; evaluate the data supplied relating to quality and their conformity to international standards; verify the quality and authenticity of the documents supplied." The absence of a site-audit provision is an absence-of-evidence finding drawn from reading the whole procedure, not a positive statement in the text.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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MOPH may suspend or cancel the LNDMI registration and withdraw the device from the market

recall.suspension-cancellation-and-market-withdrawal

Fact-level verified

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 investigations and take adequate action: suspending or cancelling the registration of the device on the LNDMI list, and withdrawing the device in question from the market.

Conditions

The power is protective and self-initiated by the MOPH; it does not depend on a foreign recall or on a manufacturer's field-safety corrective action.
A separate provision lets the MOPH refuse, provisionally suspend or withdraw the device registration certificate on the report of the health technology unit, with a 60-day period for the holder to regularise its situation.
Importers of implantable devices must also keep their conformity certificates current or Med Import refuses their invoices.

Effective from 2013-11-01

Source language French. Original: "Le MSP prendra les mesures nécessaires pour protéger la santé publique. A cette fin, il se réserve le droit de mener les enquêtes nécessaires et prendre les actions adéquates au cas où il détecte des fraudes ou des informations trompeuses qu'un fournisseur ou n'importe quelle partie dans la chaine d'approvisionnement du dispositif médical aurait fourni. Les actions appropriées peuvent être: a. Suspendre/ annuler l'enregistrement du DM sur la liste LNDMI. b. Retrait du marché du dispositif médical en question." Translation: "The MOPH will take the measures necessary to protect public health. To that end, it reserves the right to conduct the necessary investigations and take adequate action in the case where it detects fraud or misleading information supplied by a supplier or any party in the medical-device supply chain. The appropriate actions may be: a. suspend/cancel the registration of the medical device on the LNDMI list. b. withdrawal from the market of the medical device in question."

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Registration with the MOPH health technology unit is required before any sale

pathways.pre-marketing-device-registration-required

Fact-level verified

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 sale. The application is made in two copies and must include the LNDM identification sheet printed from the MOPH online system, the conformity documents, the labelling and the user manual.

Conditions

Registration precedes sale; it is not a notification after the fact.
The application is filed with the health technology unit, which is also where the registration dossiers for the Lebanese market are deposited.
The supplier (manufacturer, importer or distributor) must also be individually declared to the MOPH before its first import operation.

Effective from 2013-11-01

Source language French. Original: "Tout fabricant, importateur ou distributeur de dispositifs médicaux doit adresser au Ministère de la Santé Publique/ Unité des technologies de la santé une demande d'enregistrement préalable à toute mise en vente. Cette demande, établie en 2 exemplaires, doit inclure les documents suivants:" Translation: "Every manufacturer, importer or distributor of medical devices must address to the Ministry of Public Health / health technology unit an application for registration prior to any placing on sale. This application, drawn up in 2 copies, must include the following documents:"

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Lebanon approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Lebanon (9 records)

LebanonUS FDA · EU conformity assessment · Health Canada · Australia TGA · Japan MHLW / PMDA

Prior approval / evidence record

Clinical evaluation is not re-performed in Lebanon; the work of GHTF regulatory authorities is used

reliance.clinical-evaluation-uses-reference-authority-work

Fact-level verified

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 carried out by the regulatory authorities of the GHTF countries. A device whose clinical evidence was assessed by the FDA, an EU notified body, Health Canada, the TGA or Japan therefore does not have that clinical evidence re-reviewed in Lebanon.
Source Approval: Regulatory authorities of the GHTF countries (US FDA, EU member states, Health Canada, Australia TGA, Japan MHLW/PMDA)
Edge Type: Assessment Report Reliance
Market Access Strength: facilitated
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Stated in Part 2 of the procedure as the assessment strategy for implantable medical devices; the same section records that the unit verifies quality data, document authenticity and coherence with the online database instead.
The unit's effort is redirected to a sampling verification driven by the device's importance and criticality, its safety profile and the manufacturer's history.
edgeType `assessment_report_reliance` is an existing registry token, used deliberately here because the mechanism is reliance on another authority's completed assessment work rather than a documentary evidence requirement (which is filed separately as `reliance.accepted-conformity-certificate-menu`).

Effective from 2013-11-01

Source language French. Original: "Les aspects relatifs à l'évaluation clinique ne seront pas abordés en faveur d'une exploitation des travaux déjà effectués par les autorités réglementaires dans les pays de la GHTF." Translation: "The aspects relating to clinical evaluation will not be addressed, in favour of making use of the work already done by the regulatory authorities in the GHTF countries."

LebanonUS FDA · EU conformity assessment · Health Canada · Australia TGA · Japan MHLW / PMDA

Prior approval / evidence record

Conformity to a GHTF reference-authority regulation is a precondition of Lebanese marketing authorisation

reliance.ghtf-reference-authority-conformity-prerequisite

Fact-level verified

Statement: To obtain authorisation to place a medical device on the Lebanese market the device must conform to at least one of the regulations in force in Canada, Australia, Japan, the United States or an EU member state. An FDA, CE, Health Canada, TGA or Japan approval is therefore the conformity basis on which the Lebanese file is admitted rather than a starting point for a fresh assessment. The device must in addition satisfy Lebanese standards where such standards exist.
Source Approval: US FDA 510(k)/PMA; EU CE marking (notified-body certificate plus manufacturer declaration of conformity); Health Canada; Australia TGA; Japan MHLW/PMDA
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

The list of jurisdictions is closed: Canada, Australia, Japan, the United States, EU member states. Korea, China and the United Kingdom are not named.
Conformity to one of the five is a precondition for the Lebanese authorisation, not a substitute for it — the MOPH health technology unit still evaluates the file and the Minister of Health issues the final decision.
Lebanese standards, where they exist, must be met in addition (LIBNOR standards, certification by the Industrial Research Institute).
The same closed list is restated at statutory level by Decision No. 455/1 of 16 April 2013, Article One (European Union, United States, Canada, Japan, Australia).
Instrument in force: the November 2013 national procedure read with Decisions 455/1 (2013) and 1506 (2014).

Effective from 2013-11-01

Source language French. Original: "Pour obtenir l'autorisation de mise sur le marché libanais, le dispositif médical doit être conforme à au moins une des réglementations en vigueur dans les pays suivants: Canada, Australie, Japon, Etats Unies, pays membres de l'union européenne. Le dispositif médical doit, par ailleurs, satisfaire les exigences des normes libanaises quand elles existent." Translation: "To obtain authorisation to place on the Lebanese market, the medical device must conform to at least one of the regulations in force in the following countries: Canada, Australia, Japan, United States, member states of the European Union. The medical device must, moreover, satisfy the requirements of Lebanese standards where they exist."

LebanonUS FDA · EU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · IMDRF member authorities

Prior approval / evidence record

Registration file must carry at least one accepted foreign conformity certificate — FDA, CE, TGA/Health Canada/Japan or IRI

reliance.accepted-conformity-certificate-menu

Fact-level verified

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 governments; a CE marking certificate issued by a notified body plus the manufacturer's declaration of conformity; a safety certificate issued by a competent authority of Australia, Canada or Japan or other IMDRF countries; a certificate of conformity to Lebanese standards issued by the Industrial Research Institute; or — for products originating outside the EU, USA, Canada, Australia and Japan — an ISO 13485 quality-system certificate. A manufacturer's authorisation for the local distributor is required in all cases.
Source Approval: US FDA 510(k)/PMA and FDA certificate for foreign governments; EU CE marking certificate plus declaration of conformity; safety certificates of Australia TGA, Health Canada, Japan and other IMDRF member authorities; Lebanese IRI certificate
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

The requirement is drafted as "at least one of" — one accepted certificate is sufficient documentary conformity evidence, but the substance of the review still runs locally.
Brazil ANVISA is added to the accepted certificate sources by Decision 1506/2014, Annex 2 (DMI-02) — see reliance.imdrf-free-sale-certificate-mandatory for the separate mandatory IMDRF free-sale certificate.
The notified body's name and number must appear clearly on the CE certificate.
Decision No. 455/1 Article Six imposes the same menu for implantable devices (EU declaration of conformity with notified-body certificates; FDA 510(k)/PMA marketing approval; a conformity certificate from the competent health authorities of Switzerland, Australia, Canada or Japan; or an IRI certificate for national products and products from countries not listed above).

Effective from 2013-11-01

Source language French. The excerpt is the contiguous run at the head of the list; the list continues on the next page, past a running header, with the CE and IMDRF bullets, quoted here separately: "o Certificat de marquage CE délivré par un organisme notifié (nom et numéro de l'organisme notifié doivent figurer d'une façon claire) ainsi que la déclaration de conformité faite par le fabricant. o Certificat garantissant la sécurité du dispositif délivré par l'une des autorités compétentes des pays suivants: Australie, Canada ou Japon et autres pays de l'IMDRF. o Certificat de conformité aux normes libanaises délivré par l'institut de recherche industriel (IRI) le cas échéant." Translation of the excerpt: "The registration application must be accompanied by at least one of the following documents: the approval of the US FDA administration (510(k) or PMA certificate); a US FDA certificate for foreign governments." Translation of the continuation: "a CE marking certificate issued by a notified body (notified body name and number must appear clearly) together with the declaration of conformity made by the manufacturer; a certificate guaranteeing the safety of the device issued by one of the competent authorities of the following countries: Australia, Canada or Japan and other IMDRF countries; a certificate of conformity to Lebanese standards issued by the industrial research institute (IRI), where applicable."

LebanonIMDRF member authorities

Prior approval / evidence record

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

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.

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'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)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)

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

LebanonSouth Korea MFDS · NMPA · ISO

Prior approval / evidence record

Products originating outside the EU/USA/Canada/Australia/Japan enter on an ISO 13485 certificate instead of a reference-authority approval

reliance.non-reference-origin-iso-13485-documentary-route

Fact-level verified

Statement: For products whose countries of origin are other than the European Union, the USA, Canada, Australia and Japan, the accepted conformity document is a certificate of conformity of the manufacturer's quality management system to ISO 13485, in place of a reference-authority approval certificate. This is the documentary channel through which a device carrying only a Korean MFDS or Chinese NMPA approval can be filed, together with the manufacturer's authorisation for the local distributor.
Source Approval: Korea MFDS; China NMPA; any other authority outside the EU, USA, Canada, Australia and Japan
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

The ISO 13485 certificate is documentary evidence only: it substitutes for the foreign approval certificate in the file, it does not create a shortened or abridged review, and the MOPH health technology unit still performs its own evaluation.
It sits in tension with section 6.3 provision 24, which requires conformity to at least one of the five listed regulations; the procedure resolves that by drafting the ISO 13485 bullet specifically for origins outside the five, so a non-reference-origin product is admitted on QMS evidence rather than on a reference-authority approval.
The device may instead be certified by the Industrial Research Institute against Lebanese or reference international specifications for national products or products from countries not listed.
The manufacturer's authorisation for the distributor to commercialise the products on the Lebanese market is required in every case.

Effective from 2013-11-01

Source language French. Original: "Un certificat de conformité à la norme ISO 13485 du système de gestion de la qualité du fabricant pour les produits dont les pays d'origine sont autres que l'Union Européenne, USA, Canada, Australie et Japon." Translation: "A certificate of conformity to the ISO 13485 standard for the manufacturer's quality management system, for products whose countries of origin are other than the European Union, USA, Canada, Australia and Japan."

LebanonSouth Korea MFDS · NMPA

Prior approval / evidence record

No reliance route for Korean MFDS, Chinese NMPA or other non-GHTF approvals — a separate evaluation track applies

reliance.no-reliance-route-non-ghtf-approvals

Fact-level verified

Statement: A Korean MFDS, Chinese NMPA or other approval from outside the GHTF reference set is named in neither the closed five-jurisdiction conformity list nor the GHTF conformity requirement, and it opens no abridged or recognition route. The procedure instead provides a distinct evaluation track for medical devices that have no approval obtained from one of the regulatory authorities of the GHTF countries, so such a device is assessed on its own dossier rather than through reliance.
Source Approval: none
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

The reference set is the GHTF founding countries — Canada, Australia, Japan, the United States and the EU member states — as fixed by section 6.3 provision 24 and section 6.3 provision 28 ("au moins un système réglementaire des pays fondateur de la GHTF").
The device is not barred from the market: it moves to the separate evaluation track for devices without a GHTF-authority approval, and may still qualify documentarily under the ISO 13485 bullet for non-reference origins.
The procedure's terminology shifts between GHTF (2013 national procedure) and IMDRF (Decision 1506/2014 and the certificate menu); the IMDRF shift widened the accepted certificate sources — it added Brazil ANVISA — but did not widen the market-authorisation conformity list.
No regional mutual-recognition instrument applies: Lebanon is not a GCC member state and no GHTF/IMDRF reliance agreement binds it beyond the provisions of this procedure.

Effective from 2013-11-01

Source language French. Original: "Evaluation des dispositifs médicaux qui n'ont pas d'approbation obtenue de l'une des autorités réglementaires des pays de la GHTF." Translation: "Evaluation of medical devices that do not have an approval obtained from one of the regulatory authorities of the GHTF countries." This is the procedure's own separate step for devices lacking a GHTF-authority approval; read with section 6.3 provision 24, whose list of jurisdictions is closed.

LebanonIMDRF member authorities

Prior approval / evidence record

Free sale certificate / certificate for foreign government from an IMDRF member country is a mandatory registration document

reliance.imdrf-free-sale-certificate-mandatory

Fact-level verified

Statement: In addition to the documents required by Article Six of Decision No. 455/1 of 16 April 2013, a registration application must be accompanied by a free sale certificate or a certificate for foreign government issued by one of the countries belonging to the IMDRF (International Medical Devices Regulators Forum) — that is, proof that the device is sold in one of those countries, whatever its origin. This is a separate and mandatory documentary condition, not a route to a shortened review. (Decision No. 1506/1 of 1 September 2014, Article Four.)
Source Approval: Free sale certificate or certificate for foreign government issued by an IMDRF member country (the decision names the IMDRF group rather than individual authorities)
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Mandatory whatever the origin of the device: the decision states the device must be sold in one of these countries regardless of where it is manufactured.
This is a documentary requirement and does not itself shorten the Lebanese assessment; it is filed alongside the conformity certificate menu.
Decision 1506/1 Annex 2 (form DMI-02) lists the accepted certificates as FDA 510K/PMA, the CE certificate types (FullQAS, TypEC, VerifEC, ProdtnQAS, ProdctQAS, DesEC, DeclEC), Canada CMDCAS, Japan JIS, Australia TGA, Brazil ANVISA, free sale certificate, certificate for foreign government and the IRI certificate.

Effective from 2014-02-18

Source language Arabic; the PDF is a scan with no text layer and the text was recovered by OCR (pdftoppm -r 300 -png + tesseract -l ara+eng), so the wording is an OCR reading and Arabic-Indic digits are unreliable — hence source-backed-partial. OCR original: "إضافة الى المستندات المطلوبة في المادة السادسة من القرار رقم 1/455 تاريخ 2013/4/16، يرفق بطلب التسجيل شهادة بيع حر Free sale certificate أو certificate for foreign government صادرة عن احدى الدول المنتمية الى مجموعة IMDRF (International Medical Devices Regulators Forum) اي انها تباع في واحدة من هذه الدول مهما كان منشؤها." Translation: "In addition to the documents required under Article Six of Decision No. 455/1 of 16/4/2013, the registration application shall be accompanied by a free sale certificate or a certificate for foreign government issued by one of the countries belonging to the IMDRF (International Medical Devices Regulators Forum); that is, that it is sold in one of these countries, whatever its origin." The article number (المادة الرابعة, Article Four) is legible in the OCR.

LebanonSouth Korea MFDS · NMPA · ISO

Prior approval / evidence record

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

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.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

LebanonUS FDA · EU conformity assessment · Swissmedic · Australia TGA · Health Canada · Japan MHLW / PMDA

Prior approval / evidence record

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)

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.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

Review clocks

What review, validation, and applicant stop-clock rules apply?

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The 2013 procedure fixes no review period for device registration; deficiency responses get a case-by-case deadline and 'délais d'examen' is only a performance indicator

clock.no-fixed-registration-review-period-deficiency-deadline-set-case-by-case

Fact-level verified

The national procedure sets no time limit within which the health technology unit or the Minister must decide a device-registration application. Where a dossier is incomplete the unit may go back to the applicant to request complements 'with indication of a deadline for the reply', fixed case by case. The procedure's conclusion lists 'délais d'examen des demandes d'enregistrement' only as an example indicator by which application of the procedure could be evaluated.

Conditions

Verified negative: the whole 40-page procedure was read; the only fixed period it contains is the 60-day regularisation period after a refusal/suspension/withdrawal decision (already recorded under submission-communications-appeal).
Decisions 455/1 and 1506 (Arabic scans) may contain periods not visible here; none was found in the OCR text used for the existing facts.

Effective from 2013-11-01

Source language French. Translation: 'Where the application is incomplete, the health technology unit may go back to the applicant to request additional information, indicating a deadline for the reply. […] Examples of these indicators could be: periodicity and frequency of meetings; review periods for registration applications; number of registration applications per year.'

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

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Dedicated dossier track for devices subject to special conditions: transplant tissues, animal-origin components, coronary stents

special-access.special-conditions-dossier-categories

Fact-level verified

The registration process provides for the evaluation of registration dossiers for medical devices subject to special conditions, naming tissues dedicated to transplantation, medical devices containing components of animal origin, and coronary stents.

Conditions

These categories are handled as their own dossier type within the registration process, not as an emergency or compassionate-use exemption.
The procedure contains no separate named derogation, exemption or special-access authorisation route for unapproved devices; the only special track evidenced is this special-conditions dossier category.
Medical devices comprising components of human origin are excluded from the procedure entirely and fall under article 36 of law No. 367 of 1994.

Effective from 2013-11-01

Source language French. Original: "Evaluation des dossiers d'enregistrement des dispositifs médicaux soumis à des conditions spéciales (tissus dédiés à être transplantés, dispositifs médicaux qui contiennent des composants d'origine animale, les stents coronaires)." Translation: "Evaluation of registration dossiers for medical devices subject to special conditions (tissues dedicated to being transplanted, medical devices containing components of animal origin, coronary stents)."

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

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The Industrial Research Institute is the accredited body issuing conformity certificates for imported medical devices

standards.iri-is-the-conformity-certification-body

Fact-level verified

Under Decision No. 455/1 the Industrial Research Institute (معهد البحوث الصناعية) is the body accredited to issue all the conformity certificates required by Article One for imported medical equipment, instruments and supplies, conformity being verified through the mechanism of Decree No. 5305 of 28 October 2010 (Article Three); it is also the issuing body for conformity to Lebanese or reference international specifications for national products and for products imported from countries outside the reference list (Article Six).

Conditions

The Health Engineering Service grants entry permits only after the legal conditions are met, in particular the IRI conformity certificate and payment of the charge imposed by Law No. 193 of 18 November 2011, and the competent MOPH departments do not endorse customs declarations unless the declaration is accompanied by those documents (Article Four).
The certificate from the IRI is an alternative accepted document in the registration file where it applies.

Effective from 2013-07-01

LIBNOR has adopted European device standards as Lebanese national standards and works to make them mandatory by decree; the health technology unit evaluates dossiers against LIBNOR-adopted standards

standards.libnor-adopts-european-device-standards-as-national-standards

Fact-level verified

The Lebanese Standards Institution (LIBNOR) has for some years adopted European standards relating to medical devices as national standards and is working to make them mandatory through publication of the corresponding decrees. In evaluating a registration dossier, the health technology unit forms its own decision taking into account the standards adopted by international and local institutions (LIBNOR, etc.) concerning the device in question, where applicable.

Conditions

No list of the adopted standards is published in the procedure.

Effective from 2013-11-01

Source language French. Complements the existing facts on mandatory Lebanese standards and on IRI as certification body by naming the standards body and the evaluation benchmark.

Mandatory Lebanese standards apply where they exist; otherwise EU/US/Canada/Japan/Australia requirements are adopted

standards.mandatory-lebanese-standards-where-they-exist

Fact-level verified

Under Decision No. 455/1 of 16 April 2013, Article One, a conformity certificate is imposed on all imported medical equipment, instruments and supplies; mandatory Lebanese standards are adopted where they exist, and where they do not exist the non-mandatory Lebanese standards or the requirements issued by the European Union or by the United States of America, Canada, Japan or Australia are adopted. The November 2013 national procedure (§6.3 provision 24) restates the rule: the device must also satisfy the requirements of Lebanese standards where they exist.

Conditions

LIBNOR, the Lebanese standards institute, has adopted European medical-device standards as national standards and works to make them mandatory by publishing the corresponding decrees (§5).
The conformity certificate to Lebanese or reference international specifications is issued by the Industrial Research Institute (Decision 455/1 Art. Three).
A certificate of conformity to Lebanese standards issued by the IRI is itself one of the accepted documents in the registration file, where applicable (§7.2.1 item 2).

Effective from 2013-11-01

Source language French. Original: "Le dispositif médical doit, par ailleurs, satisfaire les exigences des normes libanaises quand elles existent." and (7.2.1 item 2) "Certificat de conformité aux normes libanaises délivré par l'institut de recherche industriel (IRI) le cas échéant." Translation: "The medical device must, moreover, satisfy the requirements of Lebanese standards where they exist." / "Certificate of conformity to Lebanese standards issued by the industrial research institute (IRI), where applicable." The statutory statement of the same rule is in Decision 455/1 Article One (declared separately and marked source-backed-partial).

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

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The health technology unit issues an opinion; the Minister of Health issues the final decision

submission.opinion-to-minister-and-final-decision

Fact-level verified

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 Health for the issue of the final decision. Where the application is incomplete the unit may go back to the applicant to request supplementary information, indicating a deadline for the response. Each registration application receives its own reception order number, used as the common reference for all subsequent exchanges between the applicant and the MOPH.

Conditions

Assessment begins after receipt of the application and provides a technical appreciation, after the earlier stage of administrative appreciation (completeness check against a reception sheet).
The unit evaluates the file to elaborate its own decision, taking account of the standards adopted by international and local institutions (LIBNOR, etc.) for the device in question, where applicable.
No statutory review clock or maximum processing time for the MOPH is set in the procedure.

Effective from 2013-11-01

Source language French. Original (step 6): "Une fois l'évaluation du dossier terminée, l'unité des technologies de la santé émettra un avis sur la base des informations fournies et de ses constatations qui sera transmis au Ministre de la Santé pour l'émission de la décision finale." and (step 5) "Au cas où la demande serait incomplète, l'unité des technologies des la santé peut se retourner vers le demandeur pour demander des compléments d'informations avec indication d'un délai pour la réponse." Translation: "Once the assessment of the file is complete, the health technology unit will issue an opinion on the basis of the information supplied and of its findings, which will be transmitted to the Minister of Health for the issue of the final decision." / "Where the application is incomplete, the health technology unit may go back to the applicant to request supplementary information, indicating a deadline for the response."

Refusal, provisional suspension or withdrawal of the registration certificate, with a 60-day period to regularise

submission.refusal-suspension-withdrawal-and-sixty-day-remedy

Fact-level verified

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 holder has a period of 60 days from the date of notification of the decision to regularise its situation in accordance with the observations of the health technology unit, failing which the decision takes effect as of right.

Conditions

The 60-day period is the holder's remedy window; it is not an appeal to an external body.
No independent appeal tribunal or administrative-review procedure for registration decisions is set out in the procedure.
The power sits with the Minister on the unit's report, mirroring the power to grant the certificate on the unit's opinion.

Effective from 2013-11-01

Source language French. Original: "Le Ministère de la Santé Publique peut, sur rapport de l'unité des technologies de la santé, refuser, suspendre provisoirement ou retirer le certificat d'enregistrement du dispositif médical concerné. Le titulaire dispose d'un délai de 60 jours à partir de la date de notification de la décision pour régulariser sa situation conformément aux observations de l'unité des technologies de la santé, faute de quoi la décision prend effet de plein droit." Translation: "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 holder has a period of 60 days from the date of notification of the decision to regularise its situation in accordance with the observations of the health technology unit, failing which the decision takes effect as of right."

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

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Devices are identified with GMDN coding and a unique national code communicated to customs

udi.gmdn-coding-and-unique-national-code

Fact-level verified

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 list, and those codes must be communicated to the customs directorate in order to standardise the identification of these devices.

Conditions

The identification runs through the LNDMI/LNMDI national list of implantable medical devices maintained by the MOPH.
No unique device identification (UDI) carrier requirement on the label is set by the procedure; identification is by GMDN plus the MOPH-assigned national code and the LNDM sheet code.
Devices or supplies must be entered in the MOPH computerised system before the LNDM identification sheet can be printed and attached to the registration application.

Effective from 2013-11-01

Source language French. Original: "Les DM doivent être identifiés suivant la liste établie par le MSP qui se base sur le système de codification GMDN; un code unique sera attribué à chaque DM figurant sur la liste LNMDI, ces codes devant être communiqués à la direction des douanes dans un but d'uniformisation de l'identification de ces dispositifs." Translation: "Medical devices must be identified according to the list established by the MOPH, which is based on the GMDN coding system; a unique code will be assigned to each medical device appearing on the LNMDI list, these codes having to be communicated to the customs directorate for the purpose of standardising the identification of these devices."

Supplier and hospital traceability registers, with a patient information sheet on discharge

udi.supplier-and-hospital-traceability-registers

Fact-level verified

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 keep a register gathering information on all the medical devices it has placed on the market. The hospital must keep a register containing information on all the devices used on patients, clearly stating the patient and device identifiers, must ensure that staff complete the medical record adequately, and must give the patient an information sheet on the device used on discharge.

Conditions

Decision 455/1 Article Eight imposes parallel duties for implantable devices: the supplier must keep a register recording the import date, the quantities imported and the parties to which the consignment was distributed, to facilitate tracing and recall; health institutions must keep a register of the names of the persons who received implanted devices and materials, with their addresses and telephone numbers.
Supplier declaration includes a signed undertaking to take part in the traceability protocols run by manufacturers and in the market-surveillance system for products already in service (§6.2 provision 15; §7.1 item 3).
The LNDMI is publicly accessible for consultation in order to strengthen the traceability of declared devices (§6.3 provision 25).

Effective from 2013-11-01

Source language French. Original (provision 7): "Le fournisseur doit tenir un registre rassemblant des informations sur tous les dispositifs médicaux qu'il a mis sur le marché." and (provision 8): "L'hôpital doit tenir un registre comprenant les informations sur tous les DM utilisés sur des patients en précisant d'une façon claire les identifiants patient et DM et s'assurer que le personnel remplit le dossier médical d'une façon adéquate. Une fiche d'information sur le DM utilisé doit être donnée au patient à la sortie." Translation of the excerpt: "The hospital must keep a register comprising information on all the medical devices used on patients, clearly stating the patient and device identifiers, and must ensure that staff complete the medical record adequately. An information sheet on the medical device used must be given to the patient on discharge." Translation of provision 7: "The supplier must keep a register gathering information on all the medical devices it has placed on the market."

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

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MOPH relays alerts to patients and users, including alerts from GHTF member-country competent authorities

vigilance.moph-alert-dissemination-including-ghtf-authority-alerts

Fact-level verified

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 information may be manufacturer notifications or alerts coming from the competent authorities in GHTF member countries — a post-market information-reliance channel running in parallel to the premarket reliance routes.

Conditions

The MOPH then takes the measures necessary to protect public health, reserving the right to conduct the necessary investigations and take adequate action where it detects fraud or misleading information from a supplier or any party in the device supply chain.
Those actions can be suspending or cancelling the registration of the device on the LNDMI list and withdrawing the device from the market.
This is the only route evidenced by which a foreign authority's post-market action reaches the Lebanese market; the procedure does not provide for automatic recognition of a foreign suspension.

Effective from 2013-11-01

Source language French. Original: "Le MSP doit avertir les patients, utilisateurs, ou toute autre partie concernée lorsqu'il prend connaissance d'une alerte relative au DM qui met en jeu la santé publique ou la sécurité du patient. L'information peut être des notifications de fabricant, des alertes provenant des autorités compétentes dans les pays membres de la GHTF." Translation: "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 information may be manufacturer notifications, alerts coming from the competent authorities in the GHTF member countries."

Manufacturer or commercial representative must report every adverse event to the MOPH

vigilance.supplier-must-report-adverse-events

Fact-level verified

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.

Conditions

The duty is attached to the registration documents submitted for each product, so it runs with the product rather than only with the supplier entity.
The supplier declaration also requires involvement in the market-surveillance system for products already in service.

Effective from 2013-11-01

Source language French. Original: "Reporter au MSP tout événement indésirable." Translation: "Report any adverse event to the MOPH."

Related structured datasets

Classification systems · 1 record

Open 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 →

lebanon:medical-device

Jurisdiction Id

lebanon

Domains

medical-device
ivd

Name

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

Description

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.

Classes

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

Regulator

Ministry of Public Health (وزارة الصحة العامة)

Official Domains

moph.gov.lb

Source Status

official-source-verified

Reference Sources

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).

Source Title

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)

Source Url

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

Verified On

2026-09-16

Source Supports

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

Registration pathways, prior approvals and planning · 1 record

Open Lebanon registration →

Country

Lebanon

Jurisdiction Id

lebanon

Country Code

Flag

🇱🇧

Regulator

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

Regulator Abbrev

Ministry of Public Health

Region

middle-east

Tier

Risk Classification

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

Classes

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

Prior Approvals

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.

Key Requirements

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).

Local Rep Required

Yes

Local Rep Name

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

Mdsap Accepted

Mdsap Benefit

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.

Registration Validity

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

Last Updated

2026-09-16

Verification Status

partially-verified

Official Sources

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

Reviewed On

2026-09-16

Process

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
✅

Government fee schedules · 1 record

Open Lebanon fees →

Jurisdiction Id

lebanon

Country

Lebanon

Country Code

Authority

Ministry of Public Health

Low Risk Local

Min: 1000
Max: 1000
Currency: LBP
Per Product: No

High Risk Local

Min: 1000
Max: 1000
Currency: LBP
Per Product: No

Details

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

Notes

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.

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources

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

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

Open Lebanon certifications →

Slug

lebanon

Market

Lebanon

Confidence

low

Schemes

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

Official Sources

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

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Pricing

Advertising, claims & promotion

Advertising medical devices not declared to the MOPH is prohibited; advertising must not mislead

Approval validity & renewal

The device registration certificate is valid for five years and renewable on request

Authority & regime

The MOPH health technology unit is the competent authority for medical-device registration; an inter-departmental committee acts pending its establishment

Change control

Modifications run through a modification dossier; conformity certificates must be kept current or imports are blocked

Classification rules

Risk classification is taken from the reference jurisdictions rather than being a standalone Lebanese classification

Clinical investigation & performance

A device intended for clinical investigation must carry the label mention « exclusivement pour investigations cliniques »

Device definition & scope

Accessories are treated as full medical devices and must meet every provision of the procedure

Active implantable device and device accessory are defined in the procedure's lexicon

The procedure groups devices into five families: active implantables, IVDs, custom-made, disability-compensation and all other devices

Dossier requirements

Registration application in two copies with the LNDM sheet and supporting documents in English, French or Arabic

Economic-operator roles

Companies importing devices must have a local agent or distributor who registers the devices with the MOPH

Manufacturers, commercial representatives, importers and distributors must declare themselves to the MOPH and hold a manufacturer authorisation per product

Establishment, import & distribution

Implantable-device import invoices must be uploaded into MED Import before endorsement

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

The supplier-declaration dossier comprises the declaration sheet, a commercial-register certificate and a signed traceability/market-surveillance consent

Fees

Import-permit charge under Law No. 193 of 18 November 2011 is payable to the physicians’ syndicate

Label, IFU & language

Packaging label must show origin, manufacturer name and address in Arabic, English or French and carry 13 prescribed elements

Legal basis & guidance

Decision No. 1506/1 of 1 September 2014 explains the application of Decision 455/1

Decision No. 455/1 of 16 April 2013 is the statutory basis for medical-device importation and conformity

The November 2013 national procedure is the operative Lebanese guideline implemented by the MOPH health technology unit

Manufacturer PMS

The MOPH may block or cancel the supplier's authorisation for failure to honour post-market obligations

Supplier must specify storage, transport, installation and maintenance measures and train users

Official forms & portals

The LNDMI web-based registration system with MOPH-issued supplier credentials

QMS, audit & inspection

QMS is evidenced documentarily by an ISO 13485 certificate, required for non-reference-origin products

Recall, FSCA & market surveillance

MOPH may suspend or cancel the LNDMI registration and withdraw the device from the market

Registration pathways

Registration with the MOPH health technology unit is required before any sale

Reliance & recognition

Lebanon approvals and evidence in other markets (0 records)

Prior approvals and evidence for Lebanon (9 records)

Clinical evaluation is not re-performed in Lebanon; the work of GHTF regulatory authorities is used

Conformity to a GHTF reference-authority regulation is a precondition of Lebanese marketing authorisation

Registration file must carry at least one accepted foreign conformity certificate — FDA, CE, TGA/Health Canada/Japan or IRI

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

Products originating outside the EU/USA/Canada/Australia/Japan enter on an ISO 13485 certificate instead of a reference-authority approval

No reliance route for Korean MFDS, Chinese NMPA or other non-GHTF approvals — a separate evaluation track applies

Free sale certificate / certificate for foreign government from an IMDRF member country is a mandatory registration document

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

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)

Review clocks

The 2013 procedure fixes no review period for device registration; deficiency responses get a case-by-case deadline and 'délais d'examen' is only a performance indicator

Special access & derogation

Dedicated dossier track for devices subject to special conditions: transplant tissues, animal-origin components, coronary stents

Standards, testing & ancillary approvals

The Industrial Research Institute is the accredited body issuing conformity certificates for imported medical devices

LIBNOR has adopted European device standards as Lebanese national standards and works to make them mandatory by decree; the health technology unit evaluates dossiers against LIBNOR-adopted standards

Mandatory Lebanese standards apply where they exist; otherwise EU/US/Canada/Japan/Australia requirements are adopted

Submission communications & appeal

The health technology unit issues an opinion; the Minister of Health issues the final decision

Refusal, provisional suspension or withdrawal of the registration certificate, with a 60-day period to regularise

UDI, listing & traceability

Devices are identified with GMDN coding and a unique national code communicated to customs

Supplier and hospital traceability registers, with a patient information sheet on discharge

Vigilance & incident reporting

MOPH relays alerts to patients and users, including alerts from GHTF member-country competent authorities

Manufacturer or commercial representative must report every adverse event to the MOPH

Related structured datasets

More Lebanon medical device resources