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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