Lebanon medical device regulations

The national procedure for the regulation of medical devices in Lebanon, version 1 of November 2013, published by the Ministry of Public Health. Seven numbered sections and three annexes. Sections 1 to 5 set the ground: the lexicon (which adopts the device definition of article L.5211-1 of the French public health code), the introduction, the purpose and principles of the regulatory system, the objective and scope, and the actors — the Ministry's pharmacy and sanitary-engineering departments, the National Council for Scientific Research, the dentists' order, the Customs administration and the importers' syndicate, with LIBNOR having adopted European device standards as national ones. Sections 6 and 7 are the operative parts: Part 1 on importation, supplier declaration and registration on the national list, and Part 2 on how declaration and registration files are submitted and processed, including the documents to be provided (7.2.1) and how the files are handled (7.2.2), and then the transitional provisions and the conclusion. Annexe 1 is the supplier's undertaking, Annexe 2 the information collection sheet and Annexe 3 the receipt form for a device registration file. This is the instrument a Lebanese importer or supplier works through end to end, and it is the only national device procedure the Ministry publishes. It carries no decree or decision number of its own — the version and month are the only identification the document states — so the row records the published version rather than inventing a legal reference, and the procedure is recorded as guidance because it is an administrative procedure rather than a legislative instrument.