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
L03AA02	NIVESTIM	BioTech	Filgrastim - 30MIU/0.5ml	30MIU/0.5ml	Injectable solution	17,110,745 L.L
B05D	CAPD/DPCA 19Solution for peritoneal dialysis stay safe	G	Sodium chloride - 5.786g/l, Sodium-(S)-lactate - 3.925g/l, Calcium chloride 2H2O - 0.1838g/l, Magnesium chloride, 6H2O - 0.1017g/l, Anhydrous glucose - 22.73g/l, Fructose , - up to 1.1g/l		Injectable solution	769,337 L.L
C05BB02	AETHOXYSKLEROL	B	Polidocanol (Lauromacrogol 400) - 0.5%	0.50%	Injectable solution	1,441,943 L.L
J01MA02	CIPROFLOXACINE PANPHARMA	G	Ciprofloxacine (HCl) - 400mg/200ml	400mg/200ml	Injectable solution	9,908,924 L.L
L03AA02	ZARZIO	BioTech	Filgrastim - 300mcg/0.5ml	30MU/0.5ml	Injectable solution	13,053,190 L.L
N02AB02	PETHIDIN PANPHARMA	G	Pethidine HCl - 50mg/ml	50mg/ml	Injectable solution	862,747 L.L
L04AB01	ALTEBREL	BioTech	Etanercept - 50mg/1ml	50mg/1ml	Injectable solution	L.L
B05D	CAPD/DPCA 2Solution for peritoneal dialysis stay safe	G	Sodium chloride - 5.786g/l, Sodium-(S)-lactate - 3.925g/l, Calcium chloride 2H2O - 0.2573g/l, Magnesium chloride, 6H2O - 0.1017g/l, Anhydrous glucose - 15g/l, Glucose monohydrate - 16.5g/l		Injectable solution	735,741 L.L
C05BB02	AETHOXYSKLEROL	B	Polidocanol (Lauromacrogol 400) - 1%	1%	Injectable solution	1,732,213 L.L
L03AA02	ZARZIO	BioTech	Filgrastim - 300mcg/0.5ml	30MU/0.5ml	Injectable solution	13,053,190 L.L
B05D	CAPD/DPCA 3Solution for peritoneal dialysis	G	Sodium chloride - 5.786g/l, Sodium-(S)-lactate - 3.925g/l, Calcium chloride 2H2O - 0.2573g/l, Magnesium chloride, 6H2O - 0.1017g/l, Anhydrous glucose - 42.50g/l, Glucose monohydrate - 46.75g/l		Injectable solution	769,337 L.L
C05BB02	AETHOXYSKLEROL	B	Polidocanol (Lauromacrogol 400) - 3%	3%	Injectable solution	2,576,146 L.L
J01MA12	TAVANIC 500MG	B	Levofloxacin - 500mg/100ml	500mg/100ml	Injectable solution	1,988,887 L.L
L03AA13	NEULASTIM	BioTech	Pegfilgrastim - 6mg/0.6ml	6mg/0.6ml	Injectable solution	56,925,965 L.L
B05D	CAPD/DPCA 17Solution for peritoneal dialysis sleep safe	G	Sodium chloride - 5.786g/l, Sodium-(S)-lactate - 3.925g/l, Calcium chloride 2H2O - 0.1838g/l, Magnesium chloride, 6H2O - 0.1017g/l, Anhydrous glucose - 15g/l, Fructose , - up to 0.75g/l		Injectable solution	744,140 L.L
J01MA12	EVOXIL HELLAS	G	Levofloxacin - 500mg/100ml	500mg/100ml	Injectable solution	959,504 L.L
L03AA13	ZIEXTENZO	BioTech	Pegfilgrastim - 6mg	6mg	Injectable solution	42,676,168 L.L
B05D	CAPD/DPCA 19Solution for peritoneal dialysis sleep safe	G	Sodium chloride - 5.786g/l, Sodium-(S)-lactate - 3.925g/l, Calcium chloride 2H2O - 0.1838g/l, Magnesium chloride, 6H2O - 0.1017g/l, Anhydrous glucose - 22.73g/l, Fructose , - up to 1.1g/l		Injectable solution	744,140 L.L
J01MA12	LEVOFLOXACIN COOPER	G	Levofloxacin (hemihydrate) - 500mg/100ml	500mg/100ml	Injectable solution	959,504 L.L
B05DA	EXTRANEAL (ICODEXTRIN 7.5%) TWIN BAG	B	Sodium lactate - 4.5g/l, Magnesium Chloride - 0.051g/l, Calcium chloride - 0.257g/l, Sodium chloride - 5.4g/l, Icodextrin - 75.0 g/l		Injectable solution	1,998,025 L.L
J01MA12	LEVOFLOXACIN- HAMELN	G	Levofloxacin - 500mg/100ml	5mg/ml	Injectable solution	1,632,769 L.L
L03AB07	BLASTOFERON	BioTech	Interferon beta-1a - 44mcg	44mcg	Injectable solution	55,847,685 L.L
M01AE01	IBUPROFEN B. BRAUN	G	Ibuprofen - 400mg/100ml	400mg/100ml	Injectable solution	231,141 L.L
B05DA	EXTRANEAL (ICODEXTRIN 7.5%) SINGLE BAG	B	Sodium lactate - 4.5g/l, Magnesium Chloride - 0.051g/l, Calcium chloride - 0.257g/l, Sodium chloride - 5.4g/l, Icodextrin - 75.0 g/l		Injectable solution	1,998,025 L.L
J01DB04	HIKMA CEFAZOLIN	G	Cefazolin (sodium) - 1g	1,000mg	Injectable solution	215,015 L.L
J01MA12	LEVOFLOXACIN NORMON	G	Levofloxacin - 500mg/100ml	5mg/ml	Injectable solution	27,147,388 L.L
L03AB07	REBIF	BioTech	Interferon beta-1a - 44mcg/0.5ml	12MIU	Injectable solution	82,479,505 L.L
M01AE01	? IBUPROFEN	G	Ibuprofen - 400mg/100ml	400mg/100ml	Injectable solution	383,955 L.L
B03AC	FER PANPHARMA	G	Iron (sucrose) - 100mg/5ml	100mg/5ml	Injectable solution	2,315,441 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

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