List of medical device must to be granted import permit 

(According to Article 6. Circular 05/2022/TT-BYT: Elaborating Decree No. 98/2021/ND-CP dated November 8, 2021 of The Government on Management of Medical Devices)

List of medical device to be granted import permit: 

  1. X-ray imaging devices.
  2. Magnetic resonance systems.
  3. Diagnostic ultrasound equipment.
  4. Diagnostic endoscopy system.
  5. Cyclotron system.
  6. Diagnostic devices using radioactive isotopes (PET, PET/CT, SPECT, SPECT/CT, iodine concentration measuring instrument for I130, I131).
  7. Autorefractors, ophthalmometry.
  8. Electrophysiology equipment (EEG, ECG, EMG machines).
  9. Electroretinography machines.
  10. Bone densitometer.
  11. Optical coherence tomography (OCT) machine; Non-mydriatic retinal camera.
  12. Doppler fetal monitors.
  13. Spirometry.
  14. Biochemistry analyzers; Blood gas and electrolyte analyzers.
  15. Hematology analyzers; Blood type analysis instruments.
  16. Coagulation analyzers; Erythrocyte sedimentation rate analyzers.
  17. ELISA test system.
  18. Cellular extraction system.
  19. Platelet aggregation and platelet function analyzers.
  20. Microbial identification instruments.
  21. Immunoassay analyzers.
  22. In vitro reagents, calibrators, and controlled materials.
  23. Treatment devices using X-ray.
  24. Endoscopic surgical system.
  25. Radiotherapy equipment (Cobalt machine, Linear accelerator for cancer treatment, Gamma Knife, Brachytherapy equipment of all kinds).
  26. Patient monitors.
  27. Infusion pump; Electric syringe pump.
  28. Scalpel (high voltage current, laser, ultrasound).
  29. Surgical microscopes.
  30. Prostatectomy surgery set.
  31. Heart–lung machines.
  32. Surgical navigation equipment.
  33. Cryosurgery devices.
  34. Infant incubators; Heaters for infants.
  35. Anesthetic machines.
  36. Ventilators.
  37. Implantable cardioverter-defibrillators.
  38. Hyperbaric oxygen therapy chambers.
  39. Extracorporeal/intracorporeal shock wave lithotripsy.
  40. High Intensity Focused Ultrasound (HIFU) system.
  41. Hemofiltration devices.
  42. Ophthalmology surgical system (Laser Excimer, Phemtosecond Laser, Phaco, Vitreous cutter, Microkeratomes).
  43. Glasses, contact lenses (myopia, hyperopia, mixed astigmatism) and contact lens solutions.
  44. Laser devices for treatment in ophthalmology.
  45. Long-term implantable devices and instruments (more than 30 days).
  46. Invasive devices and instruments in cardiology and cranial nerves.

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