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
J06BB01	RHESONATIV	BioHuman	Human anti-D (rh) immunoglobulin - 625IU/ml	625IU/ml	Injectable solution	12,281,758 L.L
N01BB03	SCANDONEST 3% sans vasoconstricteur	B	Mepivacaine - 54mg/1.8ml	3%	Injectable solution	1,670,396 L.L
B05CX01	DEXTROSE 5% INJECTION USP	G	Glucose - 5%	5%	Injectable solution	171,228 L.L
J01GB06	MIACIN	G	Amikacin (sulfate) - 500mg/2ml	500mg/2ml	Injectable solution	2,015,764 L.L
J06BB02	TETAGAM P	BioHuman	Human Tetanus Immunoglobulin - 250IU/ml	250IU/ml	Injectable solution	3,075,475 L.L
M01AB55	DIOXAFLEX B12	G	Diclofenac sodium - 75mg, Betamethasone (sodium phosphate) - 2mg, Hydroxocobalamin sulphate - 10mg		Injectable solution	1,104,639 L.L
N01BB03	MEDICAINE 3% SANS VASOCONSTRICTEUR	G	Mepivacaine HCl - 3%	3%	Injectable solution	954,128 L.L
N05CM18	PRECEDEX (DEXMEDETOMIDINE)	B	Dexmedetomidine HCl - 200mcg/2ml	200mcg/2ml	Injectable solution	19,441,512 L.L
B05CX01	DEXTROSE 5% INJECTION, USP	G	Glucose - 5%	5%	Injectable solution	193,062 L.L
J01GB06	ORLOBIN	G	Amikacin (sulfate) - 500mg/2ml	500mg/2ml	Injectable solution	329,241 L.L
J06BB02	TETANUS GAMMA	BioHuman	Human Tetanus Immunoglobulin - 250IU/ml	250IU/ml	Injectable solution	3,077,399 L.L
M01AB55	DIOXAFLEX B12	G	Diclofenac sodium - 75mg, Betamethasone (sodium phosphate) - 2mg, Hydroxocobalamin sulphate - 10mg		Injectable solution	620,855 L.L
N01BB03	SCANDINIBSA	G	Mepivacaine HCl - 3%	3%	Injectable solution	1,191,988 L.L
A02BC01	OMEPRAZOLE-ORBUCELL	G	Omeprazole (sodium) - 40mg	40mg	Injectable solution	3,839,550 L.L
B05CX01	DEXTROSE 5% INJECTION, USP	G	Glucose - 5%	5%	Injectable solution	171,228 L.L
J06BB04	IMMUNOGLOBULINE HUMAINE DE L'HEPATITE B LFB	BioHuman	Hepatitis B immunoglobulin (human) - 100UI/ml	100UI/ml	Injectable solution	6,853,730 L.L
M01AB55	PANCLO B12	G	Diclofenac sodium - 75mg, Betamethasone disodium phosphate - 2mg, Hydroxocobalamin sulphate - 10mg		Injectable solution	1,158,392 L.L
N01BB09	ROPIVACAINA MOLTENI	G	Ropivacaine HCl - 75mg/10ml	7.5mg/ml	Injectable solution	2,332,911 L.L
B05CX01	DEXTROSE 5% INJECTION, USP	G	Glucose - 5%	5%	Injectable solution	158,587 L.L
J06BB04	IMMUNOGLOBULINE HUMAINE DE L'HEPATITE B LFB	BioHuman	Hepatitis B immunoglobulin (human) - 500UI/5ml	500UI/5ml	Injectable solution	26,599,935 L.L
M01AB55	DIFEN B12	G	Diclofenac sodium - 75mg, Prednisolone sodium phosphate - 10.08mg, Hydroxocobalamin acetate - 10.44mg		Injectable solution	978,317 L.L
N01BB09	ROPIVACAINE B. BRAUN	G	Ropivacaine HCl - 75mg/10ml	7.5mg/ml	Injectable solution	4,831,114 L.L
B05CX01	DEXTROSE INJECTION 5%	G	Dextrose, H2O - 5g/100ml		Injectable solution	212,797 L.L
N01BB52	DILOCAIN 2%	G	Lidocaine HCl - 20mg/1.7ml, Epinephrine (bitartrate) - 0.0125mg/1.7ml		Injectable solution	2,768,316 L.L
A10BX16	MOUNJARO KWIKPEN	B	Tirzepatide - 2.5mg/dose	2.5mg/dose	Injectable solution	39,601,065 L.L
B05CX01	SERUFLEX DEXTROSE 5% INJECTION USP	G	Glucose - 5%	5%	Injectable solution	171,228 L.L
J06BD01	SYNAGIS	BioTech	Palivizumab - 100mg/ml	100mg/ml	Injectable solution	57,429,464 L.L
M01AC01	INFLACAM	G	Piroxicam - 20mg/ml	20mg/ml	Injectable solution	193,513 L.L
N01BB53	MEDICAINE 2% WITH ADRENALINE	G	Mepivacaine HCl - 36mg/1.8ml, Epinephrine (tartrate) - 0.032mg/1.8ml		Injectable solution	1,652,926 L.L
A10BX16	MOUNJARO KWIKPEN	B	Tirzepatide - 5mg/dose	5mg/dose	Injectable solution	39,601,065 L.L

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