There is no expiration date for the listing number issued for Class B medical devices — it remains valid as long as there are no major changes to:he device's technical specifications

Class B medical device registration with the Vietnam MOH refers to the official notification and approval process required for legally marketing low to moderate-risk medical devices in Vietnam. This process is regulated by the Ministry of Health (MOH) under Decree 98/2021/ND-CP, which governs the management of medical devices.

To register and apply for Class B medical device registration with the Vietnam Ministry of Health (MOH), you must follow a simplified notification-based process (not full evaluation) governed by Decree 98/2021/ND-CP.

The procedures for applying for Class B medical device registration with the Vietnam Ministry of Health (MOH) follow a streamlined product listing (notification) process under Decree 98/2021/ND-CP, which came into effect on January 1, 2022.

To handle Class B medical device registration with the Vietnam Ministry of Health (MOH), you must follow a structured process defined by Decree 98/2021/ND-CP and supporting regulations. Class B devices (low-moderate risk) follow a notification (listing) process, not a full evaluation, making it more straightforward than Class C/D registration.

Processing Time for Class B Medical Devices (Vietnam MOH)

The registration process for Class B medical devices with the Vietnam Ministry of Health (MOH) is governed by Decree 98/2021/ND-CP and Circular 05/2022/TT-BYT. Class B devices are considered low-moderate risk and require a product listing (notification) before they can be imported or sold in Vietnam.

For Class B medical devices registered with the Vietnam Ministry of Health (MOH), while the listing number does not expire, there are still procedures and standards for making periodic updates or changes to ensure regulatory compliance under Decree 98/2021/ND-CP and related guidelines.