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 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
L01FF03	IMFINZI	BioTech	Durvalumab - 120mg/2.4ml	120mg/2.4ml	Injectable solution	59,776,110 L.L
L04AC05	STELARA	BioTech	Ustekinumab - 45mg	45mg	Injectable solution	157,788,141 L.L
L01FG02	CYRAMZA	BioTech	Ramucirumab - 500mg/50ml	500mg/50ml	Injectable solution	L.L
B01AB05	ENOXAMED	BioTech	Enoxaparin sodium - 2000IU Anti-XA/0.2ml	2000IU Anti-XA/0.2ml	Injectable solution	388,370 L.L
B05BB01	R-SOL	G	Calcium chloride, 2H2O - 0.033%, Potassium chloride - 0.03%, Sodium chloride - 0.86%		Injectable solution	205,933 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
L04AC05	STELARA	BioTech	Ustekinumab - 45mg	45mg	Injectable solution	157,788,141 L.L
B01AB05	LOVENOX	BioTech	Enoxaparin sodium - 2,000UI (20mg)/0.2ml	2,000UI (20mg)/0.2ml	Injectable solution	467,657 L.L
B05BB01	SERUFLEX RINGER'S INJECTION, USP	G	Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l		Injectable solution	204,554 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	FLUCTOBAR	G	Fluconazole - 100mg/50ml	100mg/50ml	Injectable solution	522,755 L.L
L04AC05	USTEKIREL	BioTech	Ustekinumab - 45mg	45mg	Injectable solution	62,284,555 L.L
N05AF05	CLOPIXOL DEPOT	B	Zuclopenthixol decanoate - 200mg/ml	200mg/ml	Injectable solution	512,004 L.L
B01AB05	PARINOX 20	BioTech	Enoxaparin sodium - 2000IU (20mg)/0.2ml	2000IU (20mg)/0.2ml	Injectable solution	188,138 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	STELARA	BioTech	Ustekinumab - 90mg	90mg	Injectable solution	157,788,141 L.L
N05AF05	CLOPIXOL ACUPHASE	B	Zuclopenthixol acetate - 100mg/2ml	100mg/2ml	Injectable solution	857,372 L.L
L04AC05	STELARA	BioTech	Ustekinumab - 90mg	90mg	Injectable solution	L.L
B01AB05	ENOXAMED	BioTech	Enoxaparin sodium - 10000IU Anti-XA/1ml	10000IU Anti-XA/1ml	Injectable solution	1,209,458 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
L01FF05	TECENTRIQ	BioTech	Atezolizumab - 1875mg/15ml	1875mg/15ml	Injectable solution	375,054,619 L.L
L04AC05	STELARA	BioTech	Ustekinumab - 90mg	90mg	Injectable solution	157,788,141 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
L04AC05	USTEKIREL	BioTech	Ustekinumab - 90mg	90mg	Injectable solution	94,672,508 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

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