Medical devices that need registration are:
The Ministry of Health will check the composition and the class of the medical device in the country of origin to decide if the medical device in question will require registration. No guidelines or regulations are available in this regard, but usually medical devices having a medical claim are considered para-pharmaceutical medical devices (similar to drugs) in Lebanon. The MOH has released a note mentioning that the following devices and supplements (not exhaustive list) are considered as para-pharmaceuticals (similar to drugs) in Lebanon: Drug Eluting stents, cements with antibiotics or other drug, embolization particles, breast implants, premature infant formulas, condoms with drugs.
The dossier requirements for medical devices considered as para-pharmaceuticals are as follows:
Dossier requirements for implantable medical devices are as following:
For medical devices not classified as para-pharmaceuticals or implantable medical devices, no registration is needed. An import permit is only required for each shipment (based on certificate of sterility (if applicable), invoice, CE/DOC or CFG) to enter the Lebanese market.