Free Lebanon medical device classification tool

What the Lebanon classifier checks

How are medical devices classified in Lebanon?

Ministry of Public Health (وزارة الصحة العامة) uses a risk-based framework. Possible classes include 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). 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. The applicable class depends on the product's intended purpose, duration of use, invasiveness, active functions, implantability, sterility, software role, and other market-specific rules.

What information does the Lebanon classifier use?

Current Ministry of Public Health (وزارة الصحة العامة) requirements and similar registered products for context. Your result includes an explanation and links to the official sources used.

Is the result an official Ministry of Public Health (وزارة الصحة العامة) classification decision?

No. The result is a preliminary estimate based on the product details you provide and the information available. Confirm the classification with the applicable authority or a qualified regulatory professional before filing.