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
L04AB01	ALTEBREL	BioTech	Etanercept - 50mg/1ml	50mg/1ml	Injectable solution	14,833,767 L.L
N03AX18	VIMPAT	B	Lacosamide - 10mg/ml	10mg/ml	Injectable solution	13,225,715 L.L
B05BB02	DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP	G	Sodium chloride - 0.9%, Glucose - 5%		Injectable solution	186,167 L.L
B05ZA	CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE SG	G	Potassium chloride - 3.92g/l, Magnesium chloride, 6H2O - 5.32g/l, Calcium chloride, 2H2O - 8.99g/l, Sodium acetate, 3H2O - 166.7g/l, Sodium chloride - 214.76g/l		Injectable solution	L.L
L04AB01	ENBREL	BioTech	Etanercept - 50mg	50mg	Injectable solution	52,197,598 L.L
N03AX18	TREPADIO	G	Lacosamide - 200mg/20ml	200mg/20ml	Injectable solution	9,569,390 L.L
B05BB02	MIXTE SIMPLE (2)	G	Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml		Injectable solution	182,720 L.L
B05ZA	CONCENTRATE SOLUTION FOR HEMODIALYSIS L	G	Potassium chloride - K+:1.5 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.75 mmol/l, Sodium acetate - Cl-:106.5 mmol/l, Sodium chloride - Na+:135 mmol/l		Injectable solution	L.L
L04AB01	ENBREL	BioTech	Etanercept - 50mg	50mg	Injectable solution	52,197,598 L.L
B05BB02	MIXTE SIMPLE (2)	G	Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml		Injectable solution	207,894 L.L
B05ZA	CONCENTRATE SOLUTION FOR HEMODIALYSIS LM	G	Potassium chloride - K+:2.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.75 mmol/l, Sodium acetate - Cl-:112 mmol/l, Sodium chloride - Na+:140 mmol/l		Injectable solution	L.L
J02AC01	FLUCONAZOLE PANPHARMA	G	Fluconazole - 200mg/100ml	200mg/100ml	Injectable solution	11,256,652 L.L
L01BB04	LITAK 10	B	Cladribine - 2mg/ml	2mg/ml	Injectable solution	134,514,787 L.L
L04AB01	ERELZI	BioTech	Etanercept - 50mg	50mg	Injectable solution	59,029,176 L.L
B05BB02	SERUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP	G	Sodium chloride - 0.9%, Glucose - 5%		Injectable solution	194,211 L.L
B05ZA	CONCENTRATE SOLUTION FOR HEMODIALYSIS LS	G	Potassium chloride - K+:1.5 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.75 mmol/l, Sodium acetate - Cl-:111.5 mmol/l, Sodium chloride - Na+:140 mmol/l		Injectable solution	L.L
J02AC01	STABILANOL	G	Fluconazole - 2mg/ml	2mg/ml	Injectable solution	1,291,789 L.L
L01BB04	LITAK 10	B	Cladribine - 10mg/5ml	10mg/5ml	Injectable solution	70,638,937 L.L
L04AB01	ERELZI	BioTech	Etanercept - 50mg	50mg	Injectable solution	26,491,346 L.L
B05BB02	SERUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP	G	Sodium chloride - 0.9%, Glucose - 5%		Injectable solution	180,421 L.L
B05ZA	CONCENTRATE SOLUTION FOR HEMODIALYSIS LS2	G	Potassium chloride - K+:1.5 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.5 mmol/l, Sodium acetate - Cl-:111 mmol/l, Sodium chloride - Na+:140 mmol/l		Injectable solution	L.L
G02CX01	TRACTOCILE	B	Atosiban acetate - 7.5mg/ml	7.5mg/ml	Injectable solution	2,592,272 L.L
J02AC01	UNIZOL MS	G	Fluconazole - 200mg/100ml	200mg/100ml	Injectable solution	1,419,098 L.L
L04AB01	ALTEBREL	BioTech	Etanercept - 25mg/0.5ml	25mg/0.5ml	Injectable solution	27,383,989 L.L
B05BB02	SOLUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP	G	Sodium chloride - 0.9%, Glucose - 5%		Injectable solution	222,941 L.L
B05ZA	CONCENTRATE SOLUTION FOR HEMODIALYSIS LS3	G	Potassium chloride - K+:2.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.60 mmol/l, Sodium acetate - Cl-:112 mmol/l, Sodium chloride - Na+:140 mmol/l		Injectable solution	L.L
G02CX01	TRACTOCILE	B	Atosiban acetate - 7.5mg/ml	7.5mg/ml	Injectable solution	8,282,804 L.L
L01BB05	FLUDARABIN EBEWE	G	Fludarabine Dihydrogenophosphate - 50mg/2ml	50mg/2ml	Injectable solution	3,567,902 L.L
L04AB01	ENBREL	BioTech	Etanercept - 25mg	25mg	Injectable solution	28,768,353 L.L
B05BB02	SOLUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP	G	Sodium chloride - 0.9%, Glucose - 5%		Injectable solution	158,587 L.L

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