Certificate of Free Sale (medical devices)

In the medical-device context, CFS denotes the Certificate of Free Sale required for imports of Class C/D devices into Vietnam. Foreign-issued CFS (typically two-year validity) plus the device-specific regulatory approval (FDA, CE, PMDA, TGA, Health Canada, NMPA, MFDS) and an ISO 13485 quality-system certificate form the standard foreign dossier. From 11 September 2026, apostille replaces consular legalisation for CFS originating from 1961 Convention member states. For Vietnamese exports, IMDA issues a Vietnamese CFS with three-year validity.

• IMDA portal: https://imda.moh.gov.vn
• Legal basis: Nghị định 98/2021/NĐ-CP + Nghị định 07/2023 + Nghị định 04/2025.