Tiếng Việt
Medical equipment plays an important role in improving the quality of health care for all people and supporting medical activities. Vietnam’s Ministry of Health has issued many regulations and lists of medical equipment to ensure the effective and safe use of circulating products. In this article, Medgate will present in detail the Ministry of Health’s medical equipment list, emphasizing popular and important medical devices, along with the management and inspection process.
What is medical equipment and what does it include?
Medical equipment is equipment, tools, supplies, software and systems used to diagnose, treat, monitor or prevent diseases, specifically:
- Diagnose, prevent, monitor, relieve symptoms or treat diseases or compensate for damage and injury.
- Check, replace, and support anatomy and physiological functions for the body.
- Supports and maintains life and function.
- Control conception and fertility problems.
- Disinfect other medical equipment.
These devices can range from simple tools such as syringes and stethoscopes to complex systems such as magnetic resonance imaging (MRI) machines, ultrasound machines, and hospital information management systems. .
Classification of medical equipment
- Class A medical devices are low-risk medical devices.
- Class B medical devices are medical devices with a low-medium risk level.
- Class C medical devices are medical devices with a medium-high level of risk.
- Class D medical equipment and drugs are medical equipment with a high level of risk.
List of medical equipment under the management of the Ministry of Health
This list is determined by product code according to the list of Vietnamese export and import goods and clearly stipulated in Circular 14/2018/TT-BYT issued on May 15, 2018, approved by the Minister of Medical.
See here:
As for equipment considered as normal goods, Circular 46/2017/TT-BYT issued in 2017 clearly stipulates the regulations for these equipment with a list. For this category, accordingly, declaration of eligibility to purchase and sell medical equipment is not required.
See here:
Classification of medical equipment
According to the provisions of Decree 36/2016/ND-CP issued in 2016 and Decree 169/2018/ND-CP issued in 2018, the classification of medical equipment must be performed by a qualified facility. classify.
The condition for a facility to classify medical equipment is to have at least 1 person with a certificate of practice in classifying medical equipment.
From 2022, the regulations in Decree 98/2021/ND-CP apply, accordingly, the classification of medical equipment must be performed by the classification facility that is the facility that holds the registration declaration. circulate or publish applicable standards (see medical equipment classification service HERE ) .
Principles must be followed when classifying medical equipment
According to the provisions of Decree 98/2021/ND-CP issued in 2021, the classification of medical equipment must be based on classification rules on the risk level of specific medical equipment.
Medical equipment has only one purpose of use, but that purpose of use can be classified into two or more different risk levels, the classification according to the highest risk level shall apply.
Medical equipment has many uses and for each purpose there is a different level of risk, the classification will apply according to the highest level of risk.
In case a medical device is designed in combination with another medical device, a separate risk classification is applied to each medical device.
In the case of in vitro diagnostic medical equipment, it is medical equipment, equipment systems involved in performing tests and reagents, controls, calibrators and control materials. separate risk level classification. However, the results of classifying necessary medical equipment must be based on the highest level of intended use for the overall medical equipment with that combination. Medical devices used for in vitro diagnosis are other products that participate in and support the performance of tests that are classified separately for risk levels.
The Minister of Health stipulates in detail the classification of medical equipment in accordance with international treaties regulating the classification of medical equipment of the Association of Southeast Asian Nations (ASEAN). which Vietnam is a member.
Above is the list of medical equipment under the specialized management of the Ministry of Health through commodity codes according to Vietnam’s import-export list and the classification of medical equipment. For advice on services related to medical equipment, call Hotline: 098.546.1894. or send to Email: medgatevn@gmail.com for Medgate to receive advice.