Excemption List of Medical Device
Exemption List for Medical Devices
| 1. | Adhesive tape |
| 2. | Ambu bag |
| 3. | Apron |
| 4. | Airway exchange guide |
| 5. | Articulating paper (dental used) |
| 6. | Simple Bandage |
| 7. | Binders; abdominal, ankle, breast, chest, sternum, wrist |
| 8. | Camera (dental/ intra-oral – no diagnostic software) |
| 9. | Cast cutter |
| 10. | Charger and battery |
| 11. | Chart (eye; amsler grid, colour discrimination, visual acuity) |
| 12. | Corrective back brace |
| 13. | Cotton ball & roll (general-purpose) |
| 14. | Thermometer (Mercury) |
| 15. | Dental dam |
| 16. | Dental impression material |
| 17. | Dental impression tray |
| 18. | Dental placers |
| 19. | Dental ring |
| 20. | Dental scaler (manual) |
| 21. | Dental sectional matrix band |
| 22. | Dental teeth protector |
| 23. | Dental liner/dental cushion |
| 24. | Tongue Depressor |
| 25. | Face barrier, resuscitation shield |
| 26. | Gel (ultrasound, ECG) |
| 27. | Gingival retraction cord |
| 28. | Hot/Cold pack |
| 29. | Immobiliser (wrist, ankle, elbow, arm, knee, shoulder, whole body) |
| 30. | Inhaler spacer |
| 31. | Marker (skin) |
| 32. | Mask and Goggle (Except N95 Mask) |
| 33. | Medical display screen (LCD monitor, television monitor, etc.) |
| 34. | Medical film processor |
| 35. | Microscope instrument set |
| 36. | Mirror (dental, hand-held , ENT, headband, ophthalmic, mouth, general & plastic surgery) |
| 37. | Orthosis (shoulder, elbow, wrist, hand, hip, knee, ankle, foot, finger, footwear insert, spine) |
| 38. | Orthotic footwear |
| 39. | Patient restraint |
| 40. | Percussion hammer, palpator |
| 41. | Pressure relieving mattress/pads |
| 42. | Projector, visual acuity |
| 43. | Radiation shield (apron, bib, blanket, eye, thyroid) |
| 44. | Retinal camera |
| 45. | Self-exam pad, breast |
| 46. | Shield (eye, face, hip, wound) |
| 47. | Sizer templates |
| 48. | Software, image viewing and recording only |
| 49. | Spirometer (manual) |
| 50. | Splint |
| 51. | Stretcher (ambulance, portable, bathroom) |
| 52. | Swab |
| 53. | Tournique Strap |
| 54. | Traction unit, non-invasive component |
| 55. | Walking aids; crutch, frame, table, stick |
| 56. | X-ray cassette; digital imaging, manual |
| 57. | X-ray film |
| 58. | Hospital Bed |
| 59. | Serum Tube Holder |
| 60. | Stool & Seat |
| 61. | Oxygen Generator / Plant / Cylinder |
| 62. | Wheel Chair |
| 63. | Examination Couch |
| 64. | Table & Chair (Examination, OT, etc.) |
| 65. | OT Lamp, Examination Lamp & Light |
| 66. | Microscope |
| 67. | Incubator |
| 68. | Water Bath/ Wax Bath / Sitz Bath |
| 69. | Dental Chair |
| 70. | Active – Passive Trainer |
| 71. | Body Exerciser |
| 72. | Support Boots |
| 73. | Rotation device |
| 74. | Bariatric Seat |
| 75. | Bike Ergometer |
| 76. | Parallel Bars |
| 77. | Wedges |
| 78. | Rolls |
| 79. | Tri stander |
| 80. | Vertical Stander |
| 81. | Sitter & Walker |
| 82. | Gait Trainer |
| 83. | Paraffin Wax |
| 84. | Stainer |
| 85. | Glass Jar |
| 86. | Cabinet |
| 87. | Trial Len Set + Frame |
| 88. | Binomag (Opthalmic Surgery) |
| 89. | Audiometers |
| 90. | Glass Slides |
| 91. | Petri Dishes |
| 92. | Loops |
| 93. | Pipettes & Tips |
| 94. | Specimen Containers (Urine/Stool) |
| 95. | Patient Trolley |
| 96. | Furnace |
| 97. | Plate Bender (Orthopedic Instrument) |
| 98. | Drip Stand |
| 99. | Weighing Machine |
| 100. | Lead Apron |
| 101. | Film Dryer |
| 102. | Stethoscope |
| 103. | Surgical Drape (not contained antiseptic) |
| 104. | External prosthesis |
| 105. | Autoclave |
| 106. | Stream Sterilizer |
Department of Food and Drug Administration
Exemption List for Medical Devices (Additional)
(Do not need to apply for Import Recommendation for the time being.)
| No. | Item Name |
|---|---|
| 1. | Agar / Culture Media |
| 2. | Adhesive Traction Kit |
| 3. | Body Composition Monitor |
| 4. | Binomag / Binocular Loupes |
| 5. | Blood Bag Tube Sealer |
| 6. | ECG Paper |
| 7. | General Laboratory Used Equipments |
| 8. | Hot Air Oven |
| 9. | Lubricant or Gel Used with Condoms |
| 10. | Medical Devices that are intended for Educational Purpose & Research Use Only |
| 11. | Microtome |
| 12. | Pneumatic Walker |
| 13. | Plasma Extractor |
| 14. | Reverse Osmosis System for Hemodialysis Machine |
| 15. | Stainer |
| 16. | Spare Parts that are not accessories of Medical Devices |
| 17. | Sphygmomanometer (BP cuff manual) |
| 18. | Surgical Gowns |
| 19. | Blood Collection Tube (Glass Tubes) |
| 20. | Centrifuge |
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