Vietnam Consolidates Medical Device Rules Under Decree 98 Framework

On March 6, 2026, Vietnam’s Ministry of Health issued “Consolidated Document No. 08/VBHN-BYT,” bringing together the current regulations governing medical device management in Vietnam into a single legal reference. The document integrates the provisions of “Decree No. 98/2021/NĐ-CP” and its amendments — including “Decree No. 07/2023/NĐ-CP” — presenting the latest Vietnam medical device regulatory framework in one consolidated text.

For companies involved in Vietnam medical device registration, import, or distribution, the consolidated document provides a clearer reference point for understanding the current regulatory requirements.

Vietnam Publishes Consolidated Medical Device Regulation

Vietnam’s medical device regulatory system has evolved through multiple decrees and amendments in recent years. Until now, companies often needed to review separate legal instruments to determine the current requirements.

“Consolidated Document No. 08/VBHN-BYT” addresses this issue by compiling the current provisions into a single reference document. The consolidated text does not introduce new regulatory requirements. Instead, it integrates the existing provisions of “Decree No. 98/2021/NĐ-CP,” Vietnam’s core medical device regulation, together with the amendments introduced by “Decree No. 07/2023/NĐ-CP.”

For regulatory affairs teams, this consolidation simplifies regulatory interpretation and compliance planning when preparing submissions or reviewing the applicable rules for placing medical devices on the Vietnamese market.

Key Regulatory Areas Covered Under the Consolidated Framework

The consolidated document reflects the full lifecycle regulatory system governing medical devices in Vietnam, from classification and registration through post-market oversight.

The framework consolidates provisions covering:

• Medical device classification and risk-based categorization
• Vietnam medical device registration and market authorization procedures
• Import licensing requirements for medical devices
• Distribution and supply chain obligations
• Post-market surveillance and compliance requirements
• Responsibilities of manufacturers, importers, and distributors

For foreign manufacturers and authorized representatives, the document simplifies regulatory research when preparing product registrations, import applications, and compliance strategies for the Vietnamese market.

Advertising Regulation Changes Introduced Under Decree No. 342/2025/NĐ-CP

In parallel with the consolidated medical device regulation, Vietnam has also updated certain rules governing medical device advertising and promotional activities.

“Decree No. 342/2025/NĐ-CP,” issued to implement provisions of the Law on Advertising, modifies aspects of advertising oversight that previously intersected with Vietnam’s medical device regulation under Decree No. 98/2021/NĐ-CP.

Under earlier provisions, advertising information was required to be publicly disclosed on the Medical Device Management Portal. Under the updated approach, this disclosure requirement has been removed. Instead, organizations and individuals remain responsible for ensuring that advertising activities comply with the Law on Advertising and other applicable regulations.

This adjustment simplifies administrative procedures while maintaining regulatory oversight over promotional activities related to healthcare products. Companies must still ensure that advertising content remains accurate, compliant, and consistent with approved product information.

A Clearer Regulatory Reference for Vietnam’s Medical Device Market

“Consolidated Document No. 08/VBHN-BYT (2026)” provides a single authoritative reference for Vietnam’s medical device regulatory framework under “Decree No. 98/2021/NĐ-CP” and its amendments. While the document does not introduce new requirements, it streamlines how companies review the current rules governing medical device registration, importation, and post-market compliance in Vietnam.

Regulatory teams responsible for Vietnam’s market access and product registration should ensure their internal regulatory references reflect the consolidated framework to avoid relying on outdated decree versions.

For organizations navigating Vietnam medical device registration and broader Asian regulatory requirements, get in touch with Cisema today. With an on-the-ground presence in Vietnam, Cisema provides regulatory intelligence and compliance support to help manufacturers understand and respond to evolving healthcare regulations across the region.

Further Information

• Explore Cisema’s services for medical device registration in Vietnam.
• Read our guide: Vietnam Medical Device Registration — A Complete Dossier Guide for Foreign Manufacturers.

References

• Consolidated Document No. 08/VBHN-BYT on the Management of Medical Devices — Ministry of Health of Vietnam
• Decree No. 98/2021/NĐ-CP on the Management of Medical Devices — Government of Vietnam
• Decree No. 07/2023/NĐ-CP Amending and Supplementing Certain Provisions of Decree No. 98/2021/NĐ-CP on the Management of Medical Devices — Government of Vietnam
• Decree No. 342/2025/NĐ-CP Detailing Certain Provisions of the Law on Advertising — Government of Vietnam