(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:
- X-ray imaging devices.
- Magnetic resonance systems.
- Diagnostic ultrasound equipment.
- Diagnostic endoscopy system.
- Cyclotron system.
- Diagnostic devices using radioactive isotopes (PET, PET/CT, SPECT, SPECT/CT, iodine concentration measuring instrument for I130, I131).
- Autorefractors, ophthalmometry.
- Electrophysiology equipment (EEG, ECG, EMG machines).
- Electroretinography machines.
- Bone densitometer.
- Optical coherence tomography (OCT) machine; Non-mydriatic retinal camera.
- Doppler fetal monitors.
- Spirometry.
- Biochemistry analyzers; Blood gas and electrolyte analyzers.
- Hematology analyzers; Blood type analysis instruments.
- Coagulation analyzers; Erythrocyte sedimentation rate analyzers.
- ELISA test system.
- Cellular extraction system.
- Platelet aggregation and platelet function analyzers.
- Microbial identification instruments.
- Immunoassay analyzers.
- In vitro reagents, calibrators, and controlled materials.
- Treatment devices using X-ray.
- Endoscopic surgical system.
- Radiotherapy equipment (Cobalt machine, Linear accelerator for cancer treatment, Gamma Knife, Brachytherapy equipment of all kinds).
- Patient monitors.
- Infusion pump; Electric syringe pump.
- Scalpel (high voltage current, laser, ultrasound).
- Surgical microscopes.
- Prostatectomy surgery set.
- Heart–lung machines.
- Surgical navigation equipment.
- Cryosurgery devices.
- Infant incubators; Heaters for infants.
- Anesthetic machines.
- Ventilators.
- Implantable cardioverter-defibrillators.
- Hyperbaric oxygen therapy chambers.
- Extracorporeal/intracorporeal shock wave lithotripsy.
- High Intensity Focused Ultrasound (HIFU) system.
- Hemofiltration devices.
- Ophthalmology surgical system (Laser Excimer, Phemtosecond Laser, Phaco, Vitreous cutter, Microkeratomes).
- Glasses, contact lenses (myopia, hyperopia, mixed astigmatism) and contact lens solutions.
- Laser devices for treatment in ophthalmology.
- Long-term implantable devices and instruments (more than 30 days).
- Invasive devices and instruments in cardiology and cranial nerves.
For consultation on document services and the registration process for medical devices, please contact the Hotline: 098.546.1894