Ministry of Health and Sports, Union of Myanmar

Food and Drug Administration, Myanmar

Quality, Safety and Protection

  
FDA Myanmar Website is officially launched at 10:26 AM September 18, 2015.

Exemption List for Medical Device

 

အစားအသောက်နှင့်ဆေးဝါးကွပ်ကဲရေးဦးစီးဌာန၏

တင်သွင်းခွင့်ထောက်ခံချက်လတ်တလောမလိုအပ်သေးသောဆေးပစ္စည်းများစာရင်း 

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

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 Sterilize

 

မှတ်ချက်။     အစားအသောက်နှင့်ဆေးဝါးကွပ်ကဲရေးဦးစီးဌာန၏တင်သွင်းခွင့်ထောက်ခံချက်မလိုအပ်သေးသော  ဆေးပစ္စည်းအမျိုးအစားများအားအပြောင်းအလဲ ရှိပါကအချိန်နှင့်တပြေးညီဆက်လက်ထုတ်ပြန်ကြေညာအသိပေးသွားမည်ဖြစ်ပါသည်။