Iran's Capabilities in the field of Medical Equipment. Dr.Mahmoud Biglar. General Director Medical Devices Department Food and Drug Organization
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1 Iran's Capabilities in the field of Medical Equipment Dr.Mahmoud Biglar General Director Medical Devices Department Food and Drug Organization
2 Overview: Medical Equipment Department, Aims & Mission Imports, exports and domestic production Size Iran Domestic products The number of available hospital beds and investment opportunities The number of existing capital equipment and investment opportunities Potential opportunities for production and development of medical equipment
3 Medical Equipment Department Aims & Mission: Monitoring and evaluation of medical, dental and laboratory equipment by issuing certificate of activity to manufacturer, dealer and distributor by legislation, defining criteria and.. Planning for real-time evaluation of activists of this area. Constant supervision on entry, release and clearance of medical equipment.
4 Planning for export of medical device by cooperation with other related organization Brand Ranking, goods Pricing and market control Legally fine of abuse and infractions Monitoring and evaluation of medical sciences universities IRC
5 Imports, exports and domestic production Size Title No (Million USD) Importer > Domestic Producer > Exporter >80 90 Local Distributor >5800
6 Iran Domestic products Patient Care Monitor Infant Incubator Hospital Beds Anesthesia Machine Electrocardiograph (ECG) Surgical Lights (LED) Surgical Gloves Electroencephalograph Surgical Suction
7 Iran Domestic products Ventilators PACS (software) Medical Gas Outlets Ceiling Pendant Elisa Kits (for in vitro Diagnostics) Clinical Chemistry Kits (for in vitro Diagnostics) Surgical Sutures with and without needle Intens Pulsed Lights(IPL) Orthopedic Implants
8 Iran Domestic products Orthoses Dental Units Syrings Allograft Hemodialysis Filter Gauzes and Bandages Patient Disposable Dressing Infant Phototherapy Fistula Needle Hemodialysis Blood Line
9 Priorities for production (Devices) Lasers, Carbon Dioxide, Surgical/Dermatologic Lasers, Diode, Dermatologic Sterilizing Units (Plasma) Dental Extraoral Radiographic Units Hemodialysis Units Clinical Chemistry, Automated Analyzers Cell Counting Automated Analyzers CT X-Ray Tubes Radiographic/Fluoroscopic Units, Mobile Intracorporeal Lithotripters Cataract Extraction Units, Phacoemulsification Radiographic Systems, Digital, Mammographic Ultrasonic Probes Scanning Systems, Gamma Camera, Single Photon Emission Tomography Radiographic Systems, Digital Extracorporeal Lithotripters Densitometers, Bone, X-Ray, Dual-Energy Absorptiometry Defibrillators, External Scanning Systems, Ultrasonic
10 Priorities for production (Single Use) Vacutainer Tubes Electronic Thermometers Wound Dressing for Professional-use Biological Cardiac Valve Intravenous Administration Sets Ostomy Collection Bags Inflators, Angioplasty Balloon Staplers Sport Medicine Implants Laryngeal-Tracheal Kits, Sutures For Professional-use Dental Composite Restorative Materials Dental Porcelains Grafts, Bone, Synthetic Angioplasty Balloons Guide Wires Coronary Artery Catheters Artificial Cardiac Valve Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting Extracorporeal Membrane Oxygenators
11 The number of available hospital beds and investment opportunities
12 The number of existing capital equipment and investment opportunities
13 Potential opportunities for production and development of medical equipment 65 Incubator Centers 2600 Knowledge-based companies 650 specialized Knowledge-based companies in the field of healthcare Specialized reference laboratories for quality control of medical equipment
14 Medical Devices Registration Scoring Phase Safety and Effectiveness Evaluation Phase Pricing Phase Post Market Evaluation
15 Registration for Import Medical Equipment 1. Manufacturing Facility Registration 2. Safety & Effectiveness Evaluation & Scoring 3. GMP Evaluation 4. Experts Committee 5. Sample Test 6. Committee Approval CE & FDA Declaration of conformity Certification of sales in country of origin Market History in USA, Europe, Japan Conformity of Technical & Essential Standards Global Market Share Label & related documents 15
16 Ministry of Health Heyat Omana Arzi (HOA) IRAN FOOD AND DRUG ADMINISTRATION Medical Equipment Procurement Process Allocating The Budget Allocating the Budget Medical Equipment Department Supervision Sellers Supply of Medical Equipment Medical Science Universities (>55) Supervision over Transactions Public Hospitals (>580)
17
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