Lebanon Medical Device Regulations

Medical Device Definition

Medical Devices: any instrument, device, equipment, material, product, except products of human origin, or other item used alone or in combination, including accessories and software involved in its
operation, intended by the manufacturer to be used in humans for medical purposes and whose desired main action is not obtained by pharmacological or immunological means or by metabolism, but whose function can be assisted by such means.

Active Medical Device: means any medical device, the operation of which depends on a source of electrical energy or any source of energy other than that generated directly by the human body or gravity and
acting by conversion of this energy. This category does not include medical devices intended to transmit energy, substances, or other elements between an active medical device and the patient without significant modification.

Active Therapeutic Device: means any active medical device used either alone or in combination with other medical devices to support, modify, replace, or restore biological functions or structures for the treatment or mitigation of disease, injury, or disability

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

Regulatory Approval Process

Additional Information