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.

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