Classification-Medical device

Classification as per the Medical device guideline-2015 of Bangladesh

Device name	Alternate name	Class
Alginate wound dressing	Alginate dressing	B
Adhesive Dressing	Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver	C
Adhesive Hydrocellular Sacrum Dressing	Hydrocellular Sacrum Dressing/Silicone Gel Hydrocellular Foam Dressing	C
Absorbent, Waterproof and Bacteria Proof Film Dressing	Absorbent, Waterproof and Bacteria Proof Film Dressing	B
Ablation device	THERMAL, ENDOMETRIAL ablation device	C
Antimicrobial Clear Silicone Adhesive Securement Dressing	Antimicrobial Clear Silicone Adhesive Securement Dressing	C
Barricade Coil System	Barricade Coil System	C
Bilirubin Perfusion Adsorption Column	Plasma Bilirubin adsorption column	C
Bioprosthesis	Bioprosthesis, Aortic, Mitral	D
Blood Glucose Monitoring system	Glucometer / Diabetes test machine	C
Blood Glucose test strip	Test strip	C
Blood line	Blood line	B
Blood bag	Single/Double/Triple	B
Blood bag with anti-coagulant	Blood bag with CPD	C
Blood Collection Tube	Blood Collection Tube	B
Blood Pressure Monitor	Digital BP Machine	B
Blood Lancet	Lancet/Lancing device	B
Blood transfusion set	Blood transfusion set	B
Brachytherapy System	Electronic Brachytherapy System	C
Bone screw/Bone plate/General spine system	Bone screw and plate (orthopedic implants)	C
BPAP machine	BiPAP & BPAP Mask	B
CPAP machine	CPAP & CPAP Mask	B
Catgut Suture	Suture	C
Cathlab System	Cathlab System	C
Casting Tape	Orthopedic Casting Tape	A
Capillary High Flux Dialyzer	Dialyzer	C
Capillary Low Flux Dialyzer	Dialyzer	C
Central Venous Catheter	CVC	C
Cervical Collar Soft with Support	Cervical Collar Soft with Support / Cervical pillow	A
Cementless and Cemented Stem System	Cementless and Cemented Stem System	D
Cement, DENTAL	Dental cement, Dental implants, Dental connectors	C
Clot Activator Tubes	Clot Activator Tubes	B
Condom, Natural rubber condom	Male Latex condom	B
Condom with NONOXYNOL-9	Condom with NONOXYNOL-9	B
Collagen Matrix Dressing	Collagen Matrix Dressing	C
Cotton Crepe Bandage	Cotton Crepe Bandage	A
Diagnostic Catheter	Ultrasound Catheter	C
Disposable Anesthesia Breathing Circuits	Disposable Anesthesia Breathing Circuits	B
Diagnostic Guidewire	Percutaneous Introduction of Catheter	C
Detachable Coil System	Detachable Coil System	C
Dental Chair	Dental/wheel chair	A
Dental water unit	Dental equipment	A
Dental adhesive system	ETCHANT, PRIMER, ADHESIVE	C
ECG machine	Electrocardiogram device	B
ECG electrode	ECG Electrode	B
Embolic Coil System	Embolic Coil for aneurysm	D
Endotracheal tube	ET Tube	B
Endoscopic Ligator	Endoscopic Ligator	B
ENT Blades	ENT Blades	B
Extracorporeal blood circuit	tubing set for haemodialysis	B
Examination Gloves	Vinyl/Latex Examination Gloves	A
Fistula needle	Disposable Fistula Needle	B
Feeding tube	Feeding tube	B
Foley Tempsensor	Foley Tempsensor	C
Endoscopic gastrostomy (PEG) Kit	Gastrostomy Kit	B
Guiding Catheter	Coronary Guiding Catheter	C
Guide Sheath	Guide Sheath	C
Gastrostomy (PEG) Kit	Gastrostomy Kit	B
Glue for surgical tissue	Glue for tissue	C
Hemorrhoid Stapler	Stapler/Cutter	C
Hemodialysis catheter	Hemodialysis catheter	C
Heart lung machine	Heart lung machine	C
Heart Lung pack	Heart Lung pack tube	C
Hearing aid	Hearing aid machine	B
Hemoperfusion Cartridge	Cartridge	C
Haemodialyser	Disposable Haemodialyser	C
Haemodialysis machine	Kidney Dialysis Machine	C
Hemoglobin Analyzer	Hemoglobin Analyzer	C
HIV test kit	HIV rapid test kit	C
Heat Disinfection of Haemodialysis Machine	Disinfectant for machine cleaning	B
Hyaluronic Acid	hyaluronic acid implant for Orthopedics	C
Hydrogel Wound Dressing	Hydrogel Wound Dressing	B
Injection Site adapter	Injection Site adapter	B
IV Cannula	Disposable IV Cannula	B
IV Catheter with connector	IV Catheter with injection stopper/with Injection valve/with Dressing	B
IVUS Catheter	IVUS Catheter	C
Introducer Sheath	Introducer Sheath	B
Infusion set	IV Infusion set	B
Infusion pump	Pump, Infusion	C
Insulin Pen Needle	Insulin Pen Needle	B
Intramedullary Nails	Intramedullary Nails	C
Intrauterine Contraceptive Device	Cupper T, IUD	C
Intraocular Lens	Lens, intraocular / multifocal	C
Intraoral scanner	Intraoral/extraoral camera	A
Injection stopper	Injection stopper	A
Image guided therapy	Image guided therapy	C
Immunoassay Analyzer	Immunoassay Analyzer	C
Lithium Heparin Tubes	Lithium Heparin Tubes	B
Liquid Embolic System	Embolic System	C
Low Adherent Absorbent Dressing	Low Adherent Absorbent Dressing	B
Magnetic resonance system	MRI Machine	C
Manifolds	Manifold	C
Microporous Surgical Tape	Surgical tape	A
Moisture Responsive Cannula Dressing	Moisture Responsive Cannula Dressing	B
Nasal Oxygen Cannula	Nasal Oxygen Cannula	B
Needle	Blood collection/Dental/Angiographic/hypodermic/Spinal/Fistula needle	B
Needle Free Injector	Needle Free Injector	B
Nebulizer/Nebulizer mask	Nebulizer for oxygen/Oxygen mask	B
Non-Woven Adhesive Wound Dressing	Adhesive Wound Dressing	B
Non-Woven Face Mask	Non-Woven Face Mask	A
Non-Adhesive Hydrocellular Antimicrobial Heel Dressing	Non-Adhesive Hydrocellular Antimicrobial Heel Dressing	C
Non-Adhesive Hydrocellular Polyurethane Heel Dressing	Non-Adhesive Hydrocellular Polyurethane Heel Dressing	C
Non-Adhesive Hydrocellular Polyurethane Dressing	Non-Adhesive Hydrocellular Polyurethane Dressing	C
Oximeter	Pulse/Ear/Finger Oximeter	C
Operating Light	Spot light/headlight/Dental OT light	A
OT Table	Operation table	A
OTW balloon catheter	PTA (over the wire) balloon dilatation catheter	C
Oxygen concentrator	Portable Oxygen concentrator system	B
Pacemaker Cardiac	Implantable cardiac pulse Generator	D
Pacemaker lead	Implantable lead for pacemaker	D
Pressure transducer	Pressure transducer	B
Polypropylene mesh	Mesh (Surgical)	C
Plaster of Paris	Plaster of Paris bandage	A
Pregnancy test kit	hCG Pregnancy rapid test kit	B
Peripheral stent	Peripheral stent	C
PTCA Balloon Catheter	Percutaneous transluminal coronary angioplasty balloon catheter	C
Renal Replacement Therapy Machine	Dialysis machine	C
Revascularization Device	Revascularization Device	C
Respiratory Exerciser	Exerciser for respiration	A
Surgical Suture	Suture	C
Surgical Gloves	Sterile latex surgical gloves	B
Surgical Cap	Surgical Cap	A
Skin Stapler	Stapler	B
Silicone Foley Catheter	Foley Catheter	B
Silicone Scar Sheet	Scar Silicone Sheet	B
Silicon Gel Adhesive Antimicrobial Hydrocellular Foam Dressing	Hydrocellular Foam Dressing	C
Stethoscope, Electronic	Electronic Stethoscope	B
Stethoscope, Manual	Manual stethoscope	A
Sphygmomanometer	Sphygmomanometer/manual BP machine	A
Suction set	Suction set	B
Syringe	any type of syringe	B
Stent / Coronary stent system	Cardiovascular stent	D
Stent Graft System	Stent Graft System	C
Sodium Hyaluronate	Sodium Hyaluronate 1.6% & 2%	C
Software for X-ray angiographic image analysis	X-ray software
Transcatheter Heart Valve	Heart Valve	D
Thermometer	Digital/Electronic/Chemical color change/Infrared	B
Thermometer (Mercury)	Mercury Thermometer for clinical use	A
Thoracic drainage catheter	Thoracic drainage catheter	B
Trocar	for abdominal/antrum/thoracic/Gastro/ENT/Ovarian/Gall Bladder	B
Ultrasonic surgical system	Ultrasonic surgery	C
Ultrasound System	Ultrasound machine	B
Umbilical cotton tape	Umbilical cord tape	A
Urine Bag	Urine bag	A
Urine Test Strips	Urine Test Strip	B
Ureteral Stent	Ureteral Stent	D
Varicose Vein Stockings	Stockings	A
Ventilator machine	Ventilator device	C
X-Ray System	Diagnostic X Ray machine	C
X-Ray film	X Ray film, MRI Film	A

Govt. fees for Class A = BDT 0 and Govt. Fees for Class B, C & D = BDT 63,250/product

Class A = Low risk, Class B = Low-Moderate risk, Class C = Moderate-high risk, Class D = High risk

PHARMA DRA

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Classification as per the Medical device guideline-2015 of Bangladesh

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