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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
B05BA01 AMINOPLASMAL B. BRAUN B Amino acids - 10% 10% Injectable solution 1,036,103 L.L
B05BA01 AMINOVEN INFANT B L-Leucine - 13g/l, L-Isoleucine - 8g/l, L-Lysine Acetate - 12g/l, L-Methionine - 3.12g/l, L-Phenylalanine - 3.75g/l, L-Threonine - 4.40g/l, L-Tryptophan - 2.01g/l, L-Valine - 9g/l, Arginine - 7.5g/l, L-Histidine - 4.76g/l, Glycine - 4.15g/l, L-Taurine - 0.40g/l, L-Serine - 7.67g/l, L-Alanine - 9.3g/l, L-Proline - 9.71g/l, N-Acetyl-L-Tyrosine - 5.176g/l, N-Acetyl-L-Cysteine - 0.70g/l, L-Malic Acid - 2.62g/l 10% Injectable solution 880,217 L.L
B05BA01 AMINOVEN 10% B Glacial Acetic Acid 99% - 5.297g/l, L-Proline - 15.0g/l, L-Alanine - 15.0g/l, Glycine - 14.0g/l, L-Histidine - 3.00g/l, L-Arginine - 12.0g/l, L-Valine - 6.20g/l, L-Tryptophan - 2.00g/l, L-Threonine - 4.40g/l, L-Phenylalanine - 5.10g/l, L-Methionine - 4.30g/l, L-Lysine (monoacetate) - 6.60g/l, L-Leucine - 7.40g/l, L-Isoleucine - 5.00g/l Injectable solution 951,440 L.L
B05AA07 VOLUVEN B Starch poly(O-2-Hydroxyethyl) - 6% 6% Injectable solution 987,724 L.L
B05AA06 GELASPAN B Gelatine, succinylated - 4% 4% Injectable solution 9,107,572 L.L
B05AA01 YDRALBUM 200G/L BioHuman Albumin human - 10g/50ml Injectable solution 3,417,391 L.L
B05AA01 VIALEBEX BioHuman Albumin human - 200g/L 200g/L Injectable solution 3,417,391 L.L
B05AA01 UMAN ALBUMIN BioHuman Albumin human - 20g/100ml 10g/50ml Injectable solution 3,598,810 L.L
B05AA01 PLASBUMIN-20 ALBUMIN (HUMAN) BioHuman Albumin human - 20% 20% Injectable solution 3,641,813 L.L
B05AA01 HUMAN ALBUMIN BEHRING 20%, LOW SALT BioHuman Albumin human - 20% 20% Injectable solution 4,177,896 L.L
B05AA01 HUMAN ALBUMIN 20% SOLUTION BioHuman Albumin human - 20% 20% Injectable solution 4,177,896 L.L
B05AA01 HUMAN ALBUMIN "OCTAPHARMA" 20% BioHuman Albumin human - 20% 20% Injectable solution 4,863,366 L.L
B05AA01 ALBUTEIN BioHuman Human Albumin - 20% Injectable solution 4,031,528 L.L
B05AA01 ALBUTEIN BioHuman Human Albumin - 20% 20% Injectable solution 7,154,928 L.L
B05 SOLUFLEX POTASSIUM CHLORIDE 20meq/l SODIUM CHLORIDE 0.9% INJECTION USP G Sodium chloride - 0.9%, Potassium chloride - 20meq/l Injectable solution 232,134 L.L
B05 SOLUFLEX POTASSIUM CHLORIDE 40meq/l SODIUM CHLORIDE 0.9% INJECTION USP G Sodium chloride - 0.9%, Potassium chloride - 40meq/l Injectable solution 293,041 L.L
B05 20 MEQ POTASSIUM OF 0.9% SODIUM CHLORIDE INJECTION USP B Sodium chloride - 0.9%, Potassium chloride - 20mEq Injectable solution 229,959 L.L
B05 20 MEQ POTASSIUM OF 0.9% SODIUM CHLORIDE INJECTION USP B Sodium chloride - 0.9%, Potassium chloride - 20meq Injectable solution 278,102 L.L
B05 20 MEQ POTASSIUM OF 5% DEXTROSE AND 0.45% SODIUM CHLORIDE INJECTION USP B Dextrose, H2O - 5%, Sodium chloride - 0.45%, Potassium chloride - 20meq Injectable solution 229,959 L.L
B03XA06 REBLOZYL BioTech Luspatercept - 75mg 75mg Injectable powder for solution 377,881,318 L.L
B03XA06 REBLOZYL BioTech Luspatarcept - 25mg 25mg Injectable powder for solution 125,960,784 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 40,000IU 40,000IU Injectable freeze dried powder + diluent 6,316,060 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 40,000IU 40,000IU Injectable solution 11,210,836 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 20,000IU 20,000IU Injectable freeze dried powder + diluent 5,438,531 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 10,000IU 10,000IU Injectable freeze dried substance+diluent 2,490,140 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 4,000IU 4,000IU Injectable freeze dried substance+diluent 33,852,747 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 4,000IU 4,000IU Injectable freeze dried substance+diluent 940,690 L.L
B03XA01 EPOTIN BioTech Erythropoietin recombinant human (Epoetin alfa) - 4,000IU/ml 4,000IU/ml Injectable solution 11,317,795 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 4000IU 4000IU Injectable solution 4,748,244 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 4000IU 4000IU Injectable solution 1,127,036 L.L
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