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 |