Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksLebanon medical device certification and licence checker
Check Lebanon requirements beyond medical-device classification, including radio, electrical, metrology, radiation, import, environmental, and product-specific routes.
5 maintained routes11 official source links
Preliminary applicability · country-specific scope
What you receive
Not just a yes or no
A route-by-route answer. Separate product certificates, dossier evidence, import documents, and facility licences stay separate.
Trigger reasoning. See which product facts matter and which missing facts prevent a reliable conclusion.
Official starting points. Open the regulator or government sources behind the maintained country matrix.
How to read the answer
Classification is only the first layer
A device may have one medical risk class and still trigger separate radio, electrical, measurement, radiation, environmental, import, or installation requirements. The checker keeps each regulatory object separate.
Dossier or import evidence
Testing can belong inside the medical dossier, while some documents apply to each shipment.
Site or operator licence
Radiation, installation, use, or measurement controls may apply to a facility or operator.
Country-specific scope
Medical device certification routes in Lebanon
Wireless / radio
TRA type approval for radio and telecommunications terminal equipment
Applies when the product, feature, component, or use is in scope.
Source association reviewed
Radiation
Lebanese Atomic Energy Authority approval to import or export a device
Applies when the product, feature, component, or use is in scope.
Source association reviewed
Product-specific
Industrial Research Institute conformity certificate for imported devices
Handled as an import or shipment-level obligation.
Source association reviewed
Import CoC / PVoC
Reference-authority certificate and free-sale certificate in the device registration file
Handled as an import or shipment-level obligation.
Source association reviewed
Electrical safety
Electrical safety and EMC evidence inside the device conformity and import file
Evidence is normally handled inside the medical-device registration route.
Source association reviewed
Official starting points
Use these authority pages to confirm current scope, technical rules, application routes, and transition dates. A linked source does not turn a preliminary result into an authority decision.
Ministry of Public Health (MoPH)
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
Ministry of Public Health (MoPH)
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
Ministry of Public Health (MoPH)
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
Ministry of Public Health (MoPH)
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)
Ministry of Public Health (MoPH)
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)
Ministry of Public Health (MoPH)
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
Ministry of Public Health (MoPH)
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
Ministry of Public Health (MoPH)
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
Telecommunications Regulatory Authority (TRA)
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
Ministry of Public Health (MoPH)
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
Ministry of Public Health (MoPH)
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
About this checker
A preliminary tool, not a regulatory determination
Describe the complete product — radio, power, measurement, radiation, battery, materials, accessories, intended use, import route, and existing approvals. The free checker maps those facts to the maintained Lebanon scheme matrix and links each route to its maintained source associations, with reviewed, candidate and unresolved states shown separately.
Use the result to identify questions and official sources. Final scope can depend on exact models, modules, bands, components, claims, HS codes, import structure, installation site, and current authority interpretation.
- Is this the same as medical device classification in Lebanon?
- No. Risk classification determines the main medical-device pathway. This checker runs after classification and looks for additional product certificates, dossier evidence, import documents, and facility or operator licences.
- Does “no separate certificate” mean no testing is required?
- No. Safety, EMC, performance, or other evidence can still be required inside the medical-device dossier even when there is no separate national product certificate.
- Is the result an official regulatory determination?
- No. It is a preliminary applicability assessment. Review the linked official source and confirm the final route with the relevant authority, certification body, importer, or regulatory professional.
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
Keep researching this market
More Lebanon medical device resources
Continue with this market