Market access & licensing

Under Decree 98/2021/NĐ-CP, all Class B, C, and D devices on the Vietnam market must hold a valid Marketing Authorisation Certificate (số lưu hành — MAC). Class A devices undergo a published-declaration process that is lighter than full MAC. The MAC issued under Decree 98 (and many issued under predecessor Decree 36/2016) has no fixed expiration. Pathways: • **Class A** — published declaration at the provincial Department of Health. Manufacturer or importer self-classifies, posts the technical declaration, and obtains a published-declaration receipt. Faster, lighter dossier. • **Class B, C, D** — application to IMDA (MOH) for a MAC. Dossier evaluation by IMDA. Dossier format: • From 1 January 2024, Class C and D dossiers must be submitted in the ASEAN Common Submission Dossier Template (CSDT). • Class B dossiers may follow a national format; ASEAN CSDT is encouraged. Reference-country fast track: • Products holding a valid marketing approval from a reference regulator — US FDA, Health Canada, EU notified-body CE mark, Japan PMDA, Australia TGA, China NMPA, or Korea MFDS — qualify for a technical-review waiver. The IMDA review time can drop from ~60 working days to ~10 working days. The remaining review focuses on labelling, importer documentation, and Vietnam-specific safety information. Import permits: Legacy import permits issued from 1 January 2018 to 31 December 2021, and IVD registration numbers issued from 1 January 2014 to 31 December 2019, were auto-extended to 31 December 2024 by Decree 07/2023/NĐ-CP. Holders should monitor whether further extensions are issued.

Core framework: • Decree 98/2021/NĐ-CP — issued 8 November 2021, effective 1 January 2022. Chapters on classification, registration, MAC issuance, and import. • Decree 07/2023/NĐ-CP — issued 3 March 2023. Amends Decree 98/2021 with transitional rules and the reference-country fast-track mechanism. • Circular 05/2022/TT-BYT — issued 1 August 2022. Detailed dossier and evaluation procedures. Fees: • Circular 43/2024/TT-BTC — effective 1 July to 31 December 2024. 30% discount on medical-device evaluation fees during this window. Cross-references: • Examination and Treatment Law 15/2023/QH15 — sets standards for the clinical use of medical devices in healthcare facilities (effective 1 January 2024). • Risk Classification — see the Risk Classification page for the rule set determining the licensing pathway.

2024 — Mandatory ASEAN CSDT for Class C/D + 30% fee discount: CSDT format mandatory from 1 January 2024. Circular 43/2024/TT-BTC reduced evaluation fees by 30% during the second half of 2024 to ease the transition. 2024 — Examination and Treatment Law in force: Law 15/2023/QH15 took effect on 1 January 2024, setting clinical-use standards for medical devices that complement Decree 98/2021's market-access regime. 2023 — Decree 07/2023 fast track and transitional fixes: Introduced the reference-country waiver (review time ~10 working days) and the automatic extension of legacy import permits and IVD numbers to 31 December 2024. 2022 — Decree 98/2021 and Circular 05/2022 took effect: Replaced Decree 36/2016 and Decree 169/2018; introduced the no-expiry MAC and the four-tier risk classification.