List Of Registered Implantable Medical Devices At MOPH

List of Registered Implantable Medical Devices at MOPH

The Ministry of Health (MoPH), in cooperation with the “Agence Française de sécurité du médicament et des produits de santé (Ansm)” is implementing aregulatory system for the importation and use of medical devices; this project is conducted in a context where the health authorities give priority to the optimum use of resources, market assessment and the exercise of a post-marketing surveillance that will respond to any sanitary measures according to the latest international guidelines.

Based on the Decision No.455/1 Dated 16/04/2013, rules and procedures have been established for:

The import of medical devices in Lebanon including the qualification of suppliers.
The registration of medical devices in the MoPH.
The post-market surveillance of medical devices placed on the market.

The procedure sets the requirements and conditions for the import and registration of medical devices as well as the qualifications of suppliers.

In summary,

A medical device supplier must declare beforehand to the Ministry of Public Health.

Before its first commissioning, all implantable medical devices must be registered on the National List of Implantable Medical Devices to MoPH using a harmonized coding systemat national level.

Suppliers and users (public and private hospitals) must keep records to monitor post-marketing and traceability of medical devices placed on the market.

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ATC	Name	B/G	Ingredients	Dosage	Form	Price
M09AX01	HYALGAN	B	Hyaluronic acid (sodium) - 20mg/2ml	20mg/2ml	Injectable solution	3,407,985 L.L
N03AB02	? PHENYTOIN SODIUM 5% USP	G	Phenytoin (sodium) - 250mg/5ml	5ml	Injectable solution	276,448 L.L
S01JA01	FLUORESCEIN SODIUM USP IV	G	Fluorescein sodium - 10%	10%	Injectable solution	1,198,595 L.L
V03AF03	EUROFOLIC	G	Folic acid as Calcium Folinate Hydrate - 100mg/10ml	10mg/ml	Injectable solution	L.L
B05DB	DIANEAL PD4 1.36% GLUCOSE	B	Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 13.6g/l	1.36%	Injectable solution	1,163,270 L.L
J06BB02	TETAGAM P	BioHuman	Human Tetanus Immunoglobulin - 250IU/ml	250IU/ml	Injectable solution	3,075,475 L.L
M01AB05	ALMIRAL	G	Diclofenac sodium - 75mg/3ml	75mg/3ml	Injectable solution	415,247 L.L
S01JA01	FLUORESCEIN SODIUM USP IV	G	Fluorescein sodium - 10%	10%	Injectable solution	10,787,353 L.L
B05DB	DIANEAL PD4 CYCLER 1.36% GLUCOSE	B	Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 13.6g/l		Injectable solution	1,150,329 L.L
J06BB02	TETANUS GAMMA	BioHuman	Human Tetanus Immunoglobulin - 250IU/ml	250IU/ml	Injectable solution	3,077,399 L.L
M01AB05	CLOFEN	G	Diclofenac sodium - 75mg/3ml	75mg/3ml	Injectable solution	299,677 L.L
S01LA04	LUCENTIS	BioTech	Ranibizumab - 10mg/ml	10mg/ml	Injectable solution	51,255,093 L.L
D11AH05	DUPIXENT	BioTech	Dupilumab - 300mg	300mg	Injectable solution	L.L
A10AE04	BASAGLAR KWIKPEN	BioTech	Insulin glargine - 100U/ml	100U/ml	Injectable solution	4,114,846 L.L
B05DB	DIANEAL PD4 CYCLER 1.36% GLUCOSE	B	Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 13.6g/l		Injectable solution	1,150,329 L.L
J06BB04	IMMUNOGLOBULINE HUMAINE DE L'HEPATITE B LFB	BioHuman	Hepatitis B immunoglobulin (human) - 100UI/ml	100UI/ml	Injectable solution	6,853,730 L.L
M01AB05	DICLOCELL	G	Diclofenac sodium - 75mg/3ml	75mg/3ml	Injectable solution	945,809 L.L
S01LA05	EYLEA	BioTech	Aflibercept - 40mg/ml	40mg/ml	Injectable solution	65,161,855 L.L
A10AE04	GLARTUS	BioTech	Insulin glargine - 100U/ml	100U/ml	Injectable solution	1,346,530 L.L
B05DB	DIANEAL PD4 2.27% GLUCOSE	B	Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 22.7g/l		Injectable solution	1,162,424 L.L
J06BB04	IMMUNOGLOBULINE HUMAINE DE L'HEPATITE B LFB	BioHuman	Hepatitis B immunoglobulin (human) - 500UI/5ml	500UI/5ml	Injectable solution	26,599,935 L.L
M01AB05	DICLO-DENK 75 INJECTION	G	Diclofenac sodium - 75mg/3ml	75mg/3ml	Injectable solution	716,268 L.L
S01LA05	EYLEA	BioTech	Aflibercept - 8mg/0.07ml	114.3mg/ml	Injectable solution	78,332,038 L.L
A10AE04	LANTUS SOLOSTAR	BioTech	Insulin glargine - 100IU/ml	100IU/ml	Injectable solution	4,992,375 L.L
A11CC05	DIBASE	G	Vitamin D3 - 100,000IU/ml	100,000IU/ml	Injectable solution	354,774 L.L
B05DB	DIANEAL PD4 2.27% GLUCOSE	B	Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 22.7g/l		Injectable solution	1,163,270 L.L
M01AB05	DIKLORON	G	Diclofenac sodium - 75mg/3ml	75mg/3ml	Injectable solution	491,846 L.L
S01LA06	BEOVU	BioTech	Brolucizumab - 120mg/ml	120mg/ml	Injectable solution	42,752,178 L.L
A10AE04	LANTUS	BioTech	Insulin glargine - 100IU/ml	100IU/ml	Injectable solution	3,327,354 L.L
B05DB	DIANEAL PD4 CYCLER 2.27% GLUCOSE	B	Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 22.7g/l		Injectable solution	1,150,329 L.L

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