On August 3, the Hanoi Department of Health announced the results of inspection of compliance with legal regulations for medical equipment manufacturing and trading establishments of type B in the area.
From the beginning of 2026 to now, the Hanoi Department of Health has organized 4 thematic inspections. Among the 80 establishments on the list, functional forces have actually inspected 74 establishments. Six establishments cannot be inspected because their names do not coincide with the list at the actual address, coincide with the inspection schedule, or have closed or stopped operating.
Through inspection, 33/74 establishments were administratively sanctioned, accounting for 44.6%. The total amount of sanctions is 1.35 billion VND.
The main violations are related to the announcement and classification of medical equipment; not maintaining full operating conditions after announcement; dossiers have not been updated according to regulations.
Some facilities have not ensured technical personnel, warehouse storage conditions are not suitable, or the quality management system does not meet requirements.
In addition to fines, the Hanoi Department of Health suspended operations related to violations for 2 months for 7 establishments. One establishment was forced to recall, destroy or recycle medical equipment related to violations.
Notably, the dossier of a facility has been transferred to the Internal Political Security Department - Hanoi City Police for further verification and clarification.
According to initial inspection results, this facility has not been certified with ISO 13485 quality management system, and has not carried out procedures to declare eligibility for manufacturing medical equipment.
The facility has also not presented invoices and documents proving the origin of dental materials. Notably, although it does not have a medical examination and treatment operating license, the facility still shows signs of performing activities related to medical examination and treatment.
Hanoi Department of Health assessed that the rate of violating establishments is still high at 44.6%. Part of the reason is that many establishments are small and medium-sized, with limited legal capacity.
After inspection, many establishments have proactively reviewed and supplemented legal documents, technical personnel and improved the quality management system.
In the coming time, the Hanoi Department of Health will continue to conduct specialized inspections and surprise inspections in high-risk areas; strengthen post-inspection of published dossiers and the maintenance of operating conditions.
The Health sector will also coordinate with the City Police, Department of Industry and Trade, tax authorities and local authorities in managing, inspecting, and handling violations; and at the same time promote propaganda and guidance for establishments to comply with regulations on medical equipment.
