State Management of Medical Equipment

To ensure that all Vietnamese citizens have access to quality healthcare services, the Vietnamese Government has issued the National Strategy for Protection, Care, and Enhancement of People's Health with a vision towards 2030. In this strategy, the effectiveness and quality of community healthcare depend on three crucial factors: doctors, medicines, and medical equipment.

Practice has proven that medical equipment is increasingly playing a crucial role in diagnosis, treatment, and disease prevention. It has become an essential tool, providing positive support to healthcare professionals in their specialized work and is a decisive factor in the effectiveness and quality of healthcare services.

Recognizing the importance of state management of medical equipment, the Government has entrusted this task to the Ministry of Health, along with relevant ministries such as the Ministry of Science and Technology and the Ministry of Labor, Invalids and Social Affairs.

1. State management of medical equipment

1.1. State management of medical equipment by the Ministry of Health

With the responsibility of state management, the Ministry of Health has issued Circular No. 05/2022/TT-BYT on the management of medical equipment. According to this circular, inspection and calibration of medical equipment are mandatory for healthcare facilities and traders involved in importing and trading medical equipment in Vietnam.

The list of medical equipment subject to mandatory inspection as prescribed by the Ministry of Health includes:

• Ventilators
• Anesthesia machines with ventilators
• Electric surgical scalpels
• Neonatal incubators
• Defibrillators
• Hemodialysis machines...

1.2. State management of medical equipment by the Ministry of Science and Technology and the Ministry of Labor, Invalids and Social Affairs

The Ministry of Science and Technology and the Ministry of Labor, Invalids and Social Affairs have also defined a list of medical equipment that must undergo inspection.

Medical equipment requiring inspection and calibration within the scope of management by the Ministry of Science and Technology includes:

• X-ray machines
• Eye refractometers
• Eye keratometers
• Blood pressure monitors
• Medical gases
• Electrocardiogram devices
• Electroencephalogram devices...

Medical equipment requiring inspection and calibration within the scope of management by the Ministry of Labor, Invalids and Social Affairs includes:

• Medical sterilizers
• Double-layer liquid oxygen tanks
• Medical gas pipelines
• Systems for preparation, storage, and supply of medical gases...

2. Inspection activities of medical equipment

With over 65 years of establishment and development in the field of inspection, and the mission of promoting a safe and quality life for the community, Vinacontrol has been proactive in investing in human resources and modern equipment for the inspection of medical equipment. Currently, Vinacontrol has the full capacity and is designated to conduct inspections of medical equipment according to the management list of the Ministry of Health, the Ministry of Science and Technology, and the Ministry of Labor, Invalids and Social Affairs.

In 2019, in collaboration with the Ministry of Health, Vinacontrol participated in organizing workshops to disseminate the government's regulations on the management of medical equipment to healthcare facilities and businesses involved in the production, import, and supply of medical equipment.

2.1. Vinacontrol's process of inspecting medical equipment:

The inspection of medical equipment is carried out according to procedures issued by the relevant ministries, combined with a solid technical foundation and Vinacontrol's ISO 9001 quality management system.

The inspection process includes the following steps:

Step 1: Receiving requests; reviewing documents; consulting and scheduling inspections

The registration documents for inspection include:

• Inspection registration certificate
• Certificate of Origin (C/O); Certificate of Quality (C/Q)
• Circulation record/import license
• Equipment tracking and management records
• User manuals
• Other documents as required by the corresponding inspection process

Step 2: Conducting the inspection of medical equipment

• Visual inspection
• Electrical safety inspection
• Radiation safety inspection
• Other technical feature inspections as required by the corresponding inspection process
• Preparation of the inspection report

Step 3: Issuing inspection results

Medical equipment that meets the requirements after inspection will be issued a Certificate of Inspection and affixed with an inspection label indicating the serial number, inspection date, and validity.

In case the medical equipment does not meet the requirements after inspection, an Inspection Report will be issued as a basis for repair and calibration.

2.2. Commitment of Vinacontrol, the leading and pioneering organization in medical device inspection

Vinacontrol is committed to being a pioneering and leading organization in the inspection of medical equipment. They strive to fulfill their role as a mutually beneficial partner for healthcare facilities and businesses involved in the medical equipment industry, aligning with the Vietnamese Government's National Strategy for Protecting, Caring for, and Improving People's Health. The team of inspectors at Vinacontrol is carefully selected, extensively trained, highly skilled, experienced, and knowledgeable about medical equipment based on years of accumulated expertise in commercial inspection and classification of medical equipment in various maintenance, upgrade, procurement projects, and medical supply projects nationwide.

Vinacontrol's inspection services provide confidence to healthcare facilities and businesses by:

• Ensuring compliance with legal requirements and regulations set by governmental authorities.
• Ensuring the accuracy, reliability, and stable operation of medical equipment.
• Timely detection of non-compliant equipment that requires repair or replacement.
• Enhancing credibility and prioritizing the selection of healthcare facilities by patients when the equipment is inspected by a reputable organization like Vinacontrol.

With the trust of a wide range of hospitals, district-level and provincial-level healthcare facilities, as well as central-level institutions across the country, Vinacontrol will continue to make relentless efforts to further develop. Looking towards the future, their goal is to maintain their position as the leading organization for the inspection of medical equipment in Vietnam and the region.

Learn more about our Medical Equipment Inspection services: here

For consultation, you can contact them at: 0243.943.3840