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:

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.

Registration Timeline: Anywhere between 3-6 months depending on conformity of documents with requirements

License Validity: 5 years

Special Labelling Requirements:

Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

• Act as your Authorized representative

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]