Lebanon Medical Device Registration

Regulatory Authority

Ministry of Public Health

The Ministry of Public Health is concerned with preserving public health and raising its level by ensuring the prevention of diseases, treating patients in need, and supervising private health institutions in accordance with the provisions of their laws. It also prepares proposals for legislation and amendments to laws and regulations related to all fields of public health.

Link for Regulatory Authority

https://www.moph.gov.lb/

Local Regulation

Decision 455/1

Classification of Medical Devices

Medical devices classified into 16 categories according to GMDN agency

Active implantable devices
Anesthetic and respiratory devices
Dental devices
Electromechanical medical devices
Hospital hardware
In vitro diagnostic devices
Non-active implantable devices
Ophthalmic and optical devices
Reusable devices
Single-use devices
Assistive products for persons with disability
Diagnostic and therapeutic radiation devices
Complementary therapy devices
Biologically derived devices
Healthcare facility products and adaptations
Laboratory equipment

Listing or Registration Requirements

Submission of Registration application of the medical device
The technical dossier must be submitted
A technical committee will study the submitted file and either approve or request additional documentation in writing
Validation of the registration after listing in Medical Device Registration Software (MDRS) within the Projects & Health Systems Unit (MoPH)
Registration certificate issued for 5 years
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

Documents Required for Registration

Non – Implanted Medical Devices Registration Requirements:

Identification Card (DMI-01) (print out of MDRS)
Copy of the manufacturer invoice showing the manufacturer’s name, country of origin, name and address of the importer, commercial name, quantities, and dimensions for each product.

Implanted Medical Devices Registration Requirements:

Identification Card (DMI-01) related to the Implanted Medical Device (MDRS printout).
Instruction for use of the Implanted Medical Device.
Labels placed on the Implanted Medical Device package.
Copy of the manufacturer invoice.
Copy of a Certificate of Conformity to the international requirements (issued by the FDA, EC or IRI…)
Soft copies of all documents included in the Registration file.