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 F	G	Potassium chloride - 3.914g/l, Magnesium chloride, 6H2O - 3.558g/l, Calcium chloride, 2H2O - 7.719g/l, Acetic acid 100% - 6.010ml/l, Sodium chloride - 208.631g/l		Injectable solution	L.L
L01BC02	5-FROTU	G	Fluorouracil - 1000mg/20ml	1000mg/20ml	Injectable solution	577,852 L.L
L04AB02	REMSIMA SC	BioTech	Infliximab - 120mg/ml	120mg/ml	Injectable solution	125,560,051 L.L
L04AB01	ETANERREL	BioTech	Etanercept - 25mg/0.5ml	25mg/0.5ml	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	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 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
L04AB02	REMSIMA SC	BioTech	Infliximab - 120mg/ml	120mg/ml	Injectable solution	36,881,038 L.L
N04BC07	DACEPTON	G	Apomorphine HCl - 30mg/3ml	30mg/3ml	Injectable solution	13,404,432 L.L
B01AB05	LOVENOX	BioTech	Enoxaparin sodium - 2,000UI (20mg)/0.2ml	2,000UI (20mg)/0.2ml	Injectable solution	467,657 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 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
L04AB02	REMSIMA SC	BioTech	Infliximab - 120mg/ml	120mg/ml	Injectable solution	125,560,051 L.L
N04BC07	DACEPTON	G	Apomorphine HCl Hemihydrate - 100mg/20ml	100mg/20ml	Injectable solution	12,678,532 L.L
B01AB05	PARINOX 20	BioTech	Enoxaparin sodium - 2000IU (20mg)/0.2ml	2000IU (20mg)/0.2ml	Injectable solution	188,138 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 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
L04AB02	REMSIMA SC	BioTech	Infliximab - 120mg/ml	120mg/ml	Injectable solution	70,073,519 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	226,388 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
G02CX01	TRACTOCILE	B	Atosiban acetate - 7.5mg/ml	7.5mg/ml	Injectable solution	2,592,272 L.L
L04AB02	REMSIMA SC	BioTech	Infliximab - 120mg/ml	120mg/ml	Injectable solution	36,881,038 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 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	8,282,804 L.L
L04AB04	ABRILADA	BioTech	Adalimumab - 40mg	40mg	Injectable solution	40,259,574 L.L
L03AB07	REBIF	BioTech	Interferon beta-1a - 44mcg/0.5ml	12MIU	Injectable solution	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 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

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