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
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
L04AC05	STELARA	BioTech	Ustekinumab - 90mg	90mg	Injectable solution	157,788,141 L.L
N02BE01	MAKOACHE	G	Paracetamol - 1000mg/100ml	10mg/ml	Injectable solution	1,403,867 L.L
B01AB05	ENOMEX	BioTech	Enoxaparin sodium - 2000U Anti-Xa/0.2ml	2000U Anti-Xa/0.2ml	Injectable solution	396,754 L.L
B05BB01	SOLUFLEX RINGER'S INJECTION, USP	G	Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l		Injectable solution	221,792 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
L04AC05	USTEKIREL	BioTech	Ustekinumab - 90mg	90mg	Injectable solution	94,672,508 L.L
N02BE01	PARACETAMOL S.A.L.F	G	Paracetamol - 1000mg/100ml	10mg/ml	Injectable solution	5,542,006 L.L
B01AB05	ENOXA MEDIS	BioTech	Enoxaparin sodium - 2,000U Anti-Xa/0.2ml	2,000U Anti-Xa/0.2ml	Injectable solution	388,370 L.L
B05BB02	5% DEXTROSE 0.9% SODIUM CHLORIDE INJECTION	G	Dextrose,H2O - 5g/100ml, Sodium chloride - 0.9g/100ml		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
L01FG01	BEVACIREL	BioTech	Bevacizumab - 400mg/16ml	400mg/16ml	Injectable solution	49,744,595 L.L
N02BE01	STOPALGIC	G	Paracetamol - 1g/100ml	1g/100ml	Injectable solution	1,536,012 L.L
L04AB04	HUMIRA	BioTech	Adalimumab - 40mg/0.4ml	40mg/0.4ml	Injectable solution	L.L
B01AB05	ENOXAMED	BioTech	Enoxaparin sodium - 2000IU Anti-XA/0.2ml	2000IU Anti-XA/0.2ml	Injectable solution	1,105,982 L.L
B05BB02	5% DEXTROSE 0.9% SODIUM CHLORIDE INJECTION	G	Dextrose,H2O - 5g/100ml, Sodium chloride - 0.9g/100ml		Injectable solution	226,388 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
N02BE01	PARACETAMOL B.BRAUN	G	Paracetamol - 1000mg/100ml	1000mg/100ml	Injectable solution	129,009 L.L
B01AB05	ENOXAMED	BioTech	Enoxaparin sodium - 2000IU Anti-XA/0.2ml	2000IU Anti-XA/0.2ml	Injectable solution	388,370 L.L
B05BB02	5% DEXTROSE 0.9% SODIUM CHLORIDE INJECTION	G	Dextrose,H2O - 5g/100ml, Sodium chloride - 0.9g/100ml		Injectable solution	153,990 L.L
B05ZA	CONCENTRATE SOLUTION FOR HEMODIALYSIS R	G	Potassium chloride - K+:1.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.40 mmol/l, Sodium acetate - Cl-:105.8 mmol/l, Sodium chloride - Na+:140.5 mmol/l		Injectable solution	L.L
L04AC07	ACTEMRA	BioTech	Tocilizumab - 162mg/0.9ml	162mg/0.9ml	Injectable solution	79,959,812 L.L
N02BE01	PARACETAMOL MACOPHARMA	G	Paracetamol - 1000mg/100ml	10mg/ml	Injectable solution	9,350,840 L.L
B01AB05	LOVENOX	BioTech	Enoxaparin sodium - 2,000UI (20mg)/0.2ml	2,000UI (20mg)/0.2ml	Injectable solution	467,657 L.L
B05BB02	DEXTROSE 5% & SODIUM CHLORIDE 0.9%	G	Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml		Injectable solution	189,262 L.L
B05ZA	CONCENTRATE SOLUTIONFOR HEMODIALYSIS TYPE A	G	Hemodialytics, concentrates -		Injectable solution	L.L
N02BE01	PARACETAMOL NORMON	G	Paracetamol - 1000mg/100ml	10mg/ml	Injectable solution	9,633,134 L.L
B01AB05	PARINOX 20	BioTech	Enoxaparin sodium - 2000IU (20mg)/0.2ml	2000IU (20mg)/0.2ml	Injectable solution	188,138 L.L
B05BB02	DEXTROSE 5% & SODIUM CHLORIDE 0.9%	G	Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml		Injectable solution	182,720 L.L
B05ZA	CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE B+	G	Hemodialytics, concentrates -		Injectable solution	L.L

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