What are A Class medical devices and What are they included?

The classification of medical devices is crucial for obtaining import licenses and declaring standards for the circulation of these devices in the market. So, what are Class A medical devices, and what types does it encompass? In this article, Medgate will provide readers with valuable information to answer these questions.

What are Class A Medical Devices?

According to Article 4 of Decree 98/2021/ND-CP, the Ministry of Health classifies medical devices into four types based on the risk level associated with the technical design and production of these devices.

– Class A medical devices are those with the lowest level of risk.

Entities responsible for standard declaration for Class A Medical Devices include

a) Owners of medical devices are Vietnamese enterprises, cooperatives, or individual businesses.

b) Owners authorized to Vietnamese enterprises, cooperatives, or individual businesses (units with appropriate business codes for the registered product circulation).

c) Foreign traders who own medical devices with representative offices in Vietnam or units/businesses authorized by the medical device owner.

(All the above entities must have a warranty facility in Vietnam or have a contract with a capable entity to warranty medical devices, except for one-time-use medical devices or those with documented evidence of no warranty policy).

What is included in Class A Medical Devices?

Currently, the list of Class A medical devices is determined as the group with the lowest risk. This list includes various components such as devices, materials, grafting supplies, medical test drugs, and in vitro standard substances, etc. These types can be used independently or in combination according to the medical device owner’s instructions for various healthcare purposes:

• Diagnosis, prevention, monitoring, treatment, and alleviation of diseases or injuries
• Birth control
• Support in checking, replacing, adjusting, or aiding in anatomical and physiological processes, as well as maintaining life
• Life support/maintenance
• Disinfection of medical devices

Why is the Classification of Class A Medical Devices Necessary?

In the current market, there are various types of medical devices with different purposes and levels of risk. According to Decree 98/2021/ND-CP on the management of medical devices, owners of medical devices are required to classify and publicly announce the classification on the Ministry of Health’s online public service portal.

This classification process significantly impacts obtaining import licenses and the standard declaration for Class A and Class B medical devices. Therefore, accurate classification is essential to avoid potential risks in the future.

As per Decree 98/2021/ND-CP, the classification is carried out by the entity responsible for declaring standards or registering the circulation, and this entity take the responsibility.

Handling Incorrect Classifications of Class A Medical Devices

1. If a medical device is in the process of applying for a circulation number and uses an incorrect classification result, the circulation permit will not be granted.

2. If a medical device has been issued a circulation number but uses an incorrect classification result and has not completed customs clearance procedures, the customs clearance process will be halted.

3. If a medical device has been issued a circulation number, uses an incorrect classification result, has completed customs clearance, but has not been sold to end-users:

– Circulation of the medical device will be halted. Measures to retrieve the medical devices will be implemented.

– Customs will be notified not to clear subsequent batches.

– A written report will be submitted to the issuing authority, specifying the quantity of devices cleared and any purchase contracts (if applicable).

– A new circulation number must be applied for.

4. If the medical device has been sold to healthcare facilities:

a) The owner of the circulation number must report in writing to the issuing authority, specifying the quantity sold to healthcare facilities, and inform the healthcare facilities in writing.

b) If the medical device with an incorrect classification does not pose a risk to health, healthcare facilities can continue using it. The owner of the circulation number must complete the documentation after obtaining a new circulation number.

c) If the medical device with an incorrect classification poses a risk to health, healthcare facilities cannot continue using it. The owner of the circulation number is responsible for taking corrective measures to ensure the normal operation of healthcare facilities.

Timeframe for Classification and Standard Declaration of Class A Medical Devices

– The classification and standard declaration of Class A medical devices typically take 5-10 working days (excluding Saturdays and Sundays).

For consultation on document services and the registration process for medical devices, please contact the Hotline: 098.546.1894