Vietnam: New Draft Guidelines for Declaring Prices and Safety Inspection Procedures and Technical Features for Medical Devices in Vietnam
The Vietnam Ministry of Health is currently drafting a Circular to issue a list and provide guidelines for declaring the prices of medical devices. Simultaneously, the Ministry of Health has sent a letter requesting input from various organizations on the draft Circular regarding the list and guidelines for declaring prices of medical devices.
In this draft Circular, The Ministry of Health has specified the criteria for determining the price declaration of medical devices and provided a detailed list of medical devices that must declare prices, including:
- Various types and sizes of artificial intraocular lenses (IOLs, toric IOLs), including rigid, soft, and foldable.
- Drug-eluting stents for coronary arteries of various types and sizes.
- Dual-chamber pacemakers.
- Total hip joint replacements of various types and sizes.
- Partial hip joint replacements of various types and sizes.
- Knee joint replacements of various types and sizes.
Artificial spinal discs.
- Spinal fusion implants and intervertebral discs used in spinal surgery of various types and sizes.
- Surgical blades, scalpels, cartilage cutting knives, and cautery blades of various types and sizes (including scalpel handles).
- Magnetic Resonance Imaging (MRI) systems with a strength of ≥ 1.5T.
- Computed Tomography (CT) scanners with ≥ 128 slice imaging capability.
- Positron Emission Tomography (PET), PET/CT, Single-Photon Emission Computed Tomography (SPECT), and SPECT/CT scanners.
- Biochemistry analyzers (≥ 400 biochemistry tests/hour) and immunology analyzers (≥ 100 tests/hour).
- Invasive ventilators.
- The circular will be effective on 1 Jan 2024. For more details on the regulation please refer to this link.
The Ministry of Health of Vietnam is also in the process of drafting 3 (three) safety inspection procedures and technical features for medical devices. These procedures are:
- Safety inspection and technical features for cardiac defibrillator devices.
- Safety inspection and technical features for artificial kidney machines.
- Safety inspection and technical features for neonatal incubators.
The draft procedure in Vietnamese can be accessed here:
- Draft safety inspection and technical features for artificial kidney machines.
- Draft safety inspection and technical features for cardiac defibrillator.
- Draft safety inspection and technical features for neonatal incubators.
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