Safety and technical features inspection for medical equipment

Main content:

1. What is Safety and technical features inspection for medical equipment?
2. Legal documents on Safety and technical features inspection for medical equipment.
3. Which medical equipment must be tested for safety and technical features?
4. Vinacontrol's services for medical equipment.
5. Which establishments should pay attention to Decree 98/2021/ND-CP on management of medical equipment?
6. Customers have used the safety and technical features inspection service for medical equipment of Vinacontrol.

1. What is Safety and technical features inspection for medical equipment?

Safety and technical features inspection of medical equipment is a technical activity according to an inspection process to evaluate and confirm the conformity of the safety status and technical features of medical equipment, specified in the relevant technical regulations or technical standards.

2. Legal documents on Safety and technical features inspection for medical equipment.

The Government has issued many circulars and decrees to help managers, hospitals, medical units and businesses understand the regulations, clearly define their rights, responsibilities and obligations when participating in activities in the field of medical equipment: ensuring the quality and efficiency of investment and strengthening the management, exploitation and use of medical equipment, contributing to improving the quality of medical services, improving the quality of care, protect people's health.

Legal documents to control the quality of medical equipment include:

• Decree 98/2021/ND-CP issued on November 8, 2021 on the management of medical equipment
• Circular 19/2021/TT-BYT issued on November 16, 2021
• Circular 05/2022/TT-BYT issued on August 1, 2022 

3. Which medical equipment must be tested for safety and technical features?

According to Decree 98/2021/ND-CP issued on November 16, 2021 and Circular 05/2022/TT-BYT issued on August 1, 2022, there are very clear regulations on the List of medical equipment that must be inspected for safety and technical features, including:

• Breathing Machine.
• Anesthesia machine with breathing apparatus.
• Electric scalpel.
• Newborn incubator.
• Defibrillators.
• Artificial kidney machine

4. Vinacontrol's services for medical equipment: 

With a team of highly qualified inspectors, always dedicated to their work, knowledgeable in the medical field and always putting accuracy and safety first, Vinacontrol Group provide safety inspection services and technical features of medical equipment according to Decree 98/2021/ND-CP. In addition, in order to provide customers with a comprehensive and effective service package, Vinacontrol also provides other related services such as:

INSPECTION

• Quantity and type.
• Manufacturer, origin.
• Safety and technical features.
• Checking the synchronicity.
• Others.

MEDICAL DEVICE INSPECTION & Calibration

• According to the provisions of Decree 98/2021/ND-CP.
• As designated by the Ministry of Labour, War Invalids and Social Affairs; and the Ministry of Science and Technology.

INSTALLATION SUPERVISION OF MEDICAL DEVICES

• Inspect, supervise and determine the volume and quality of work during the construction and installation of medical equipment.

VALUATION

5. Customers have used the safety and technical features inspection service for medical equipment of Vinacontrol? 

• Hospitals,
• Medical facilities,
• Importers of medical equipment,
• Medical equipment manufacturing facilities and factories,
• Medical equipment trading establishments. 

6. Customers have used the safety and technical features inspection service for medical equipment of Vinacontrol.

Learn more about our Medical Equipment Inspection services: here

Contact Vinacontrol immediately for advice: (+84) 24 3943 3840