Procedures and rules for the classification of medical devices

Legal Basis

• Decree No. 98/2021/ND-CP issued on November 8, 2021: On the management of medical devices.
• Circular No. 05/2022/TT-BYT issued on August 1, 2022: Detailed regulations for implementing certain provisions of Decree No. 98/2021/ND-CP issued on November 8, 2021, by the Government on the Management of Medical Devices.

Types of Medical Devices

(According to Article 4, Decree No. 98/2021/ND-CP issued on November 8, 2021, on the management of medical devices)

Medical devices are categorized into 4 types based on the level of potential risks related to the technical design and production of those medical devices:

• Class A medical devices with low risk levels: nasal 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,…

Procedures for Classifying Medical Devices

Document Components

• Letter for Requesting medical device classification.
• Use instructions for the medical device (in Vietnamese).
• Catalogue of products (Original catalogue in English).
• Technical description document in Vietnamese along with the technical documentation describing the functions of the medical device.
• ISO 13485 Certification.
• Certificate of Free Sale (CFS).

Procedure for Classifying Medical Devices at Medgate

• Customer Information Reception: A specialist receives customer information and engages in preliminary discussions, providing initial information about the documents needed for the classification of medical devices as outlined in section 1 of Part III.
• 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.

Timeframe for Results Delivery

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

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