Lebanon medical device registration timeline

Planning steps and estimates; these are not regulator deadlines.

• File the device entry/import approval on form MPH12-26 with the Ministry's Health Engineering Service, with the invoice naming the device and its specifications (new and unused, or renewed) and the exporting company, the device specification catalogue and the letter of the beneficiary; the invoice must bear the Atomic Energy stamp (service record 4).
• Obtain the Lebanese Atomic Energy Authority's approval for import or export where the request calls for it, and expect the Authority's stamp to be a condition on the invoice (service record 4).
• Obtain the Industrial Research Institute's conformity certificate: Decision 455/1 Arts. One and Three impose a conformity certificate on all imported equipment, instruments and supplies, verify it through the mechanism of Decree No. 5305 of 28 October 2010, and accredit the Institute to issue every certificate under Art. One; Art. Four withholds the entry permit and the customs stamping until it is produced.
• Where no mandatory Lebanese specification exists, demonstrate conformity with the European Union's requirements or those of the United States, Canada, Japan or Australia (Decision 455/1 Art. One).
• For an implantable device, file the registration request with the Department of Programs and Projects before the entry declaration, with the DMI-01 identification card, the user manual, the labels on the implant packaging, a copy of the manufacturer's invoice and a conformity certificate from a reference authority (or the Institute's certificate for locally made or non-reference-origin goods) (Decision 455/1 Art. Six).
• Add the free-sale certificate issued by a country belonging to the GHTF/IMDRF group, showing the device is sold in one of those countries whatever its origin (Decision 1506/1 Art. Four).
• Classify and code the device under the GMDN nomenclature and assign its level from the Decision 1506/1 Art. Three table (Low risk, Low-To-Moderate, Moderate-To-High, High), accepting the European-system conformity documents named in Annex 1 according to that level.
• Declare as a supplier with a commercial-register number, the manufacturer's authorisation for the products, the traceability undertakings and the evidence documents, and use the credentials the Ministry issues to work in the online device registration system (November 2013 procedure §6.2 items 15-17); the Ministry's authorisation is given for one renewable year (§6.2 item 18).
• Keep the conformity certificates of devices recorded in the registration system up to date, and upload the import invoices of implanted devices through the computerised system; the Pharmacy Service's import department and the Health Engineering Service stop stamping invoices that are not uploaded (Decision 1704/1 Arts. Two, Six, from 1 December 2017; Decision 181/1 Art. Three, from 16 March 2018).
• Pay the LBP 1,000 fiscal stamp due on the application, and settle the charge imposed by Law No. 193 of 18 November 2011 in favour of the Beirut and Tripoli physicians' syndicate under the joint decision of the Ministers of Public Health and Finance No. 180/1 of 15 February 2012, which Decision 455/1 Art. Four makes a condition of the entry permit.
• For a device that is also radio or telecommunications terminal equipment, obtain the TRA's type approval, filing the Ministry of Telecommunications' import licence for importers, a Technical Compliance Folder (frequency and maximum EIRP, drawings, photographs, specification list, ISO/IEC 17025- or ILAC-accredited test reports) and a Declaration of Conformity (TRA Type Approval Regulation).
• Report any withdrawal of a product's marketing authorisation to the Ministry, and report the newly authorised supplier (November 2013 procedure §6.2 item 19); the Ministry may refuse, suspend or withdraw a registration certificate, with 60 days from notification to regularise (§7.2.2).

Reviewed 2026-09-16. End-to-end totals remain planning estimates.