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Medical devices that need registration are:

Medical devices to be classified as para-pharmaceuticals or “similar to drugs” by the MOH
Implantable medical devices

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:

Legalized Original Free sale certificate showing the classification of the product in the Country of Origin of the manufacturer; the document to be legalized by the Health Authorities (HA) (or Chamber of Commerce if the previous option is not feasible), then the Ministry of Foreign Affairs and the Lebanese Consulate in the country of origin.
Legalized original GMP (or ISO 13485) of the manufacturer by the HA, then the Ministry of Foreign Affairs and the Lebanese Consulate
Legalized plant profile or the manufacturer. The legalization is required by the Chamber of Commerce, Ministry of Foreign Affairs and the Lebanese Consulate
2 original samples + corresponding original COA signed and stamped by the manufacturer
Original Certificate of Analysis for the Active and Inactive Materials, signed and stamped
Method of analysis
Full Shelf Life Stability Data on 3 commercial batches
Storage Conditions Statement
Certificate from the manufacturer showing the product composition and shelf life
List of countries where the product is marketed
Summary of Products Characteristics
Letter of Origin of the raw material
Certificate of Sterilization
FDA / CE certificates

Dossier requirements for implantable medical devices are as following:

Descriptive form as per attached template (filled online by the local distributor) including Sterilization method and the ISO certificate of the sterilization site,
Instructions for use
Labels
GMDN Code
Copy of an invoice from the manufacturer mentioning the manufacturer name and origin, name of the agent, product name, pack size and quantity
FDA approval (CFG) or CE certificate or conformity certificate from Australia, Japan, Canada or Australia. In case none of these certificates are available, a certificate of conformity issued by the Lebanese Industrial Research Institute will be required.
Free Sale Certificate from one of the countries belonging to the International Medical Devices Regulator Forum
Soft copy of the above documents on a CD / DVD + 2 hard copies of all documents
Product price information (CIF or FOB to distributor) is being requested for implantable devices although this will not be considered a price registration by the MOH. This information is being requested for statistics and general country economical data.

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.