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Does my medical device need Reference-authority certificate and free-sale certificate in the device registration file in Lebanon?

Describe your device to check whether Reference-authority certificate and free-sale certificate in the device registration file may apply, why, what facts are missing, and which official source to review.

1 maintained routes4 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.

Maintained country rule

What this Reference-authority certificate and free-sale certificate in the device registration file check is screening

Separates reusable product approval from consignment, customs, PVoC, CoC, and HS-code documents. Handled as an import or shipment-level obligation.

Source association reviewed. The source association has been reviewed. This does not verify every rule, date or product-specific conclusion; read the cited provisions and their limits.

Requirement family: Import conformity and shipment certificates
Regulatory object: imported medical device and supply
Maintained rule status: mandatory at import
Useful product facts: HS code for every shipped object, shipment purpose, importer, origin, product certificate, and consignment details.

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.

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.

Product approval

A certificate or approval attached to the finished product, component, or radio host.

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

Other Lebanon routes to check

Check every Lebanon route →

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

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

Reviewed source associations

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)

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)

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

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.