Vietnam's medical device regulatory landscape underwent significant changes in 2023 and 2024 to improve efficiency and ensure patient safety. Two key updates, Circular 10/2023/TT-BY and Decree #07, introduced by the Ministry of Health (MoH), streamline processes, clarify requirements, and promote transparency.

Simplified Registration Process for Most Devices

• Circular 10/2023/TT-BY simplifies pre-market requirements for many medical devices. Effective January 2025, a standardized Common Submission Dossier Template (CSDT) will streamline the application process. Additionally, Class B devices are no longer required to submit Clinical Evaluation Reports (CERs), reducing hurdles for these products.

Targeted Registration for High-Risk Devices

• Decree #07, replacing Decree #98, focuses registration requirements on high-risk devices. Only Class C and D devices listed in a May 2022 circular require full registration. This allows for quicker import of lower-risk devices, with existing import licenses for these categories remaining valid until December 31, 2024. However, a backlog of applications for higher-risk devices persists, requiring MoH attention.

Enhanced Transparency and Pricing Regulations

• Decree #07 introduces new measures to stabilize device prices and optimize import procedures. Manufacturers and traders must now list prices on designated platforms like the Vietnam medical device portal, promoting transparency for consumers. Price listings are mandatory for specific devices, not all, as outlined in the decree.

Extended Deadline for ASEAN CSDT Compliance

• The deadline for adhering to the ASEAN CSDT, a standardized template for regional device registration, has been extended. This allows manufacturers more time to comply and reduces costs associated with obtaining approvals across the ten ASEAN member countries.
• The 2024 Vietnam medical device regulations aim to strike a balance between streamlined efficiency and robust safety measures. These updates simplify processes for most devices, focus registration on high-risk categories, and enhance transparency in pricing and procedures. While challenges remain with application backlogs, the overall shift reflects Vietnam's commitment to a modern and effective medical device regulatory framework.

Source: Tran Doan – Director, Pacific Bridge Medical (PBM)

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