Classification as per the Medical device guideline-2015 of Bangladesh
| Device name | Alternate name | Class |
|---|---|---|
| Alginate wound dressing | Alginate dressing | B |
| Alcohol Pad | Alcohol Pad | A |
| 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 |
| BiPAP machine | BiPAP & BiPAP 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 |
| Cochlear Implant | Implant | C |
| 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 |
| Fertility test kit | Kit for fertility test | 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 |
| Menstrual cup | Cup for Menstrual fluid | B |
| 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 |
| Uroflowmeter | Uro flow meter | B |
| 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 |
| X-Ray Tube | Tube for X Ray | C |
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
