2024 Vietnam Medical Device Regulations

In an effort to streamline and modernize its medical device regulations, Vietnam has recently implemented significant updates, aiming to enhance efficiency while ensuring the safety and efficacy of medical devices. Two key developments, Circular 10/2023/TT-BY and Decree #07 mark, substantial shifts in Vietnam’s medical device regulatory landscape.

Medical Device Registration

Released by Vietnam’s Ministry of Health (MoH), Circular 10/2023/TT-BY introduces several noteworthy changes to pre-market requirements for medical devices. Effective January 2025, device dossier applications will be required to utilize the Common Submission Dossier Template (CSDT) format, streamlining the submission process. Class B devices are no longer mandated to submit Clinical Evaluation Reports (CERs), making the registration process simpler for these products.

Under the updated regulations, only select Class C and D devices listed in Circular May 2022 need to obtain full registration. High-risk devices such as MRIs and ventilators fall under this category, while others can be imported without registration until the end of 2024. Moreover, revisions have been made to various templates, including declaration letters for Applicable Standards and application forms, to ensure alignment  with international standards. Nevertheless, difficulties remain, especially with higher-risk devices, as there is still a significant backlog of medical device applications that the Vietnamese MoH needs to review.

Medical Device Pricing and Import Procedures

Issued to replace Decree #98, Decree #07 introduces new regulations aimed at stabilizing device prices and optimizing import procedures. Notably, device traders or manufacturers are now required to list prices on the Vietnam medical device portal and other designated platforms to ensure transparency and help consumers make informed decisions.

Unlike its predecessor, Decree #07 does not require price listings for all medical devices. Instead, it outlines specific devices for which price listing is mandatory. Another noteworthy change is that import licenses obtained between January 1, 2018, and December 31, 2021, now remain valid until December 31, 2024. Additionally, Class C and Class D devices exempt from import licenses can be imported without restrictions on quantities until the end of 2024.

Moreover, Vietnam has extended the deadline for adhering to the ASEAN CSDT. CSDT is a standardized set of requirements enabling device manufacturers to submit a uniform package of product registration documentation across the regulatory bodies of ASEAN member countries. By using the CSDT, manufacturing companies can cut down on costs associated with obtaining device approvals in any of the ten ASEAN countries. This change offers businesses more time to comply with regional standards.