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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
L01BB05 FLUDARABINE PHOSPHATE NEAPOLIS G Fludarabine Dihydrogenophosphate - 50mg/2ml 50mg/2ml Injectable solution 4,031,528 L.L
L01FC01 DARZALEX BioTech Daratumumab - 1800mg 1800mg Injectable solution 514,508,654 L.L
L04AB01 ALTEBREL BioTech Etanercept - 25mg/0.5ml 25mg/0.5ml Injectable solution 27,383,989 L.L
A04AA01 ONDANSETRON HIKMA G Ondansetron (HCl dihydrate) - 4mg/2ml 4mg/2ml Injectable solution 2,228,091 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.9% G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 198,578 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
L04AB01 ENBREL BioTech Etanercept - 25mg 25mg Injectable solution 28,768,353 L.L
A04AA01 ONDANSETRON MEDIS G Ondansetron - 4mg/2ml 4mg/2ml Injectable solution 978,317 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.9% G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 226,036 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
L04AB01 ERELZI BioTech Etanercept - 25mg 25mg Injectable solution 25,751,867 L.L
A04AA01 ONDANSETRON RENAUDIN G Ondansetron (HCl dihydrate) - 4mg/2ml 4mg/2ml Injectable solution 1,791,342 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 194,211 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
L01BC01 ALEXAN G Cytarabine - 100mg/5ml 100mg/5ml Injectable solution 388,370 L.L
L04AB01 ETANERREL BioTech Etanercept - 25mg/0.5ml 25mg/0.5ml Injectable solution 5,085,100 L.L
A04AA01 ONDANSETRON VIANEX G Ondansetron (HCl) - 4mg/2ml 4mg/2ml Injectable solution 197,545 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 180,421 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE A G Hemodialytics, concentrates - Injectable solution L.L
L01BC01 ALEXAN G Cytarabine - 1,000mg/20ml 1,000mg/20ml Injectable solution 2,848,946 L.L
L04AB01 ETANERREL BioTech Etanercept - 50mg/ml 50mg/ml Injectable solution 9,756,719 L.L
A04AA01 TRONDAMET G Ondansetron (HCl) - 4mg/2ml 4mg/2ml Injectable solution 2,027,858 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 186,167 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE B+ G Hemodialytics, concentrates - Injectable solution L.L
L01BC01 CYTU G Cytarabine - 1000mg/10ml 1000mg/10ml Injectable solution 2,230,779 L.L
A04AA01 ZOFRAN INJECTION B Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 9,752,244 L.L
B05BB02 MIXTE SIMPLE (2) G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 182,720 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE J G Hemodialytics, concentrates - Injectable solution L.L
A04AA01 ODNATRON G Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 952,784 L.L
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