Classification of Medical Devices a b c d

According to Decree No. 98/2021/ND-CP issued on November 8, 2021, on the management of medical devices, medical devices are categorized into four types based on the level of potential risks related to technical design and manufacturing processes, including:

• Class A medical devices with low risk levels: inhalers,…
• Class B medical devices with medium-low risk levels:  fluid transfer lines,…
• Class C medical devices with medium-high risk levels:  ventilators,…
• Class D medical devices with high risk levels:  artificial heart valves,…

Why is the classification of medical devices necessary?

Currently, there are numerous types of medical devices on the market with different purposes and varying levels of risk. According to Decree No. 98/2021/ND-CP on the management of medical devices, the entity responsible for declaring standards or registering for circulation must classify medical devices and publicly disclose this classification on the Ministry of Health’s online public service website.

This classification affects the process of obtaining import licenses, declaring standards for Class A and B medical devices, and registering circulation for Class C and D medical devices. Therefore, accurate classification is essential to avoid potential risks in the future.

According to Decree No. 98/2021/ND-CP, the entity declaring standards or registering for circulation is responsible for the classification process. Therefore, the results of the classification must be accurate to prevent misclassification issues that may impact the entity during subsequent post-market surveillance

Principles of Medical Device Classification

– If a medical device has only one intended use, but that intended use can be classified into two or more different risk levels, the classification is applied based on the highest risk level.

– If a medical device has multiple intended uses, and each intended use has different risk levels, the classification is applied based on the highest risk level.

– If a medical device is designed for use in combination with another medical device, each medical device must be classified with a separate risk level.

(In the case of in vitro diagnostic medical devices participating in the testing process and test drugs, reference substances, standard substances, control materials, they are classified with separate risk levels. However, the classification results must be based on the highest risk level of the ultimate intended use of the overall combined medical device. In vitro diagnostic medical devices are separate products that participate in or support the testing process and are classified with separate risk levels.)

Procedure and Process for Medical Device Classification Consultation at Medgate

Understanding the concerns of customers in finding a reputable service provider for the registration of medical devices, avoiding future risks, Medgate provides professional, efficient, and reputable services for the classification, declaration of class A and B medical devices; registration of circulation for Class C and D medical devices.

– The process of implementing classification consulting is as follows:

+ Customer Information Reception: A specialist receives customer information and engages in preliminary discussions

+ Service Consultation: A specialist discusses the service process with the customer, presents cost estimates, negotiates terms, and finalizes the contract.

+ Service Implementation: The specialist checks whether the documentation is complete and complies with the regulations of the Ministry of Health. If any issues related to the documentation arise, the specialist informs the customer promptly, allowing them to supplement or amend the documents in a timely manner to avoid unnecessary delays. Subsequently, the specialist proceeds with the classification of medical devices.

+ Results Delivery: Customers receive the results of the medical device classification within 2-3 working days after the completion of the process.

To receive advice on document services, procedural processes, and registration of medical device, customers can contact the Hotline at: 098.546.1894