1. Identification sheet of a medical device printed by the supplier after entering the product into the computerized system of the MSP (identification by code sheet) (LNDM)
2. The registration request must be accompanied by at least one of the following documents:
3. Approval from the American FDA (certificate 510 (k) or PMA)
4. Certificate for foreign governments from the American FDA.
5. CE marking certificate issued by a notified body (name and number of the notified body must be clearly stated) as well as the declaration of conformity made by the manufacturer.
6. Certificate guaranteeing the safety of the device issued by one of the competent authorities of the following countries: Australia, Canada, or Japan and other member countries of the IMDRF.
7. Certificate of conformity with Lebanese standards issued by the Industrial Research Institute (IRI) if applicable
8. A certificate of conformity to the ISO 13485 standard of the quality management system of the manufacturer for products whose countries of origin are other than the European Union, USA, Canada, Australia, and Japan.
9. A certificate from the manufacturer authorizing the distributor to market the products in the Lebanese market.
10. The label affixed to the packaging showing the country of origin, the name and address of the manufacturer (in Arabic, English, or French),
11. The user manual of the device
12. The invoice from the manufacturer showing the unit price of the product

Labels should include the net weight of the product, the manufacturer, production and expiry date, ingredients, and the country of origin.  Labels should be printed on the imported goods in Arabic, English, or French.  Products with labels in Hebrew are not accepted. 

Lebanon Clinical Trials Registry (LBCTR)

List of Medical Device Recalls

The Ministry of Public Health issues the registration certificate, valid for 5 years, renewable at the request of the beneficiary