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Lebanon Medical Device Regulations

Agency
Ministry of Public Health, Republic of Lebanon, regulates medical devices in Lebanon.
Medical Device Definition
A medical device in Lebanon means any instrument, apparatus, equipment, material, product, with the exception of products of human origin, or other article used alone or in combination, including the accessories and software involved in its operation, intended by the manufacturer to be used in humans for medical purposes and of which the desired main action is not achieved by pharmacological or immunological means or by metabolism, but whose function can be assisted by such means.
Medical Device Classification System
  • Non-implantable Medical Devices
  • Implantable Medical Devices: “All medical devices that are dedicated to being implanted totally or partially, by surgical or medical intervention, in the human body or, by medical intervention in a natural orifice and are destined to be left in place after the intervention.

Based on decision 1506-2014: Medical devices are classified and coded according to Global Medical Devices Nomenclature (GMDN) which is Certified globally. Medical Devices are classified based on their level of danger according to the following table:

Risk level EU US Japan Australia Swiss Canada
Low risk I I I I I I
Low-To-Moderate II-a II II I-m, II a, Is II-a II
Moderate-To-High II-b III III II-b II-b III
High III III IV III III IV
Approval Process
Classification Approval procedure
Class I
  • The registration file is submitted to the Import / Export Department at the MOH
  • The registration file must be in English. One hard copy and one soft copy (CD or DVD) must be submitted
  • A technical committee (the same committee reviewing the drug application) will study the submitted file and either approve or request additional documentation in writing
  • The review time is 1-2 weeks. Then, the local agent/distributor will receive an approval letter signed and stamped by the MOH certifying the medical device has been classified and can be marketed
  • There is no validity end date for the registration; therefore, no renewal is required
  • No registration is needed for medical devices not classified as similar to drugs or implantable medical devices. An import permit is only required for each shipment to enter the Lebanese market
Class IIa
Class IIb
Class III
Additional Information
Approval timeline 1-2 weeks approximate
License validity period The registration process is an import permit and must be performed with every shipment. Only implantable devices are regulated at the moment.
Fees No fees are required for the registration of Medical Devices in Lebanon.
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