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Does my medical device need Industrial Research Institute conformity certificate for imported devices in Lebanon?

Describe your device to check whether Industrial Research Institute conformity certificate for imported devices may apply, why, what facts are missing, and which official source to review.

1 maintained routes2 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 Industrial Research Institute conformity certificate for imported devices check is screening

Checks listed products such as syringes, needles, gloves, condoms, implants, IUDs, and blood bags. 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: Product-specific compulsory conformity
Regulatory object: imported medical device and supply
Maintained rule status: mandatory at import
Useful product facts: Exact product category, sterile/single-use status, materials, variants, and applicable product standard.

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.

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

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

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)

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

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.