Glossary
A reference list of key terms used in Vietnamese medical device regulation. Vietnamese equivalents are provided where commonly encountered in official documents and the DMEC portal.
AMDD — ASEAN Medical Device Directive The ASEAN regulatory framework for medical devices, setting harmonised classification rules, dossier templates, and post-market obligations across ASEAN member states.
Authorised Representative (Đơn vị bảo lãnh) A legal entity registered in Vietnam appointed by a foreign manufacturer to act on its behalf for all regulatory activities, including submissions to DAV and post-market obligations.
CFS — Certificate of Free Sale A document issued by a national regulatory authority confirming that a medical device is legally marketed in the country of manufacture. Required as part of the registration dossier for Type C/D devices and Type B declarations.
Circular (Thông tư) A regulatory instrument issued by the Minister of Health providing detailed procedural rules implementing the principles set out in Government Decrees.
CSDT — Common Submission Dossier Template The ASEAN-harmonised template for organising a medical device registration dossier, adopted by Vietnam for Type C/D marketing authorisation applications.
DAV — Drug Administration of Vietnam (Cục Quản lý Dược) The national regulatory authority under MOH responsible for medical device regulation, including receiving registrations, conducting post-market surveillance, and enforcement.
Declaration (Công bố) The market access route for Type A and Type B medical devices — a self-certification process completed via the DMEC portal without a pre-market DAV technical review.
Decree (Nghị định) A legislative instrument issued by the Government of Vietnam. Decree 98/2021/ND-CP is the primary decree governing medical devices.
DMEC — National Medical Device Information System The national online portal (dmec.gov.vn) for all medical device regulatory submissions in Vietnam, including declarations, registrations, import permits, and post-market reporting.
FSCA — Field Safety Corrective Action Any action taken by a manufacturer to reduce the risk of death or serious injury associated with a medical device already on the market. Communicated through a Field Safety Notice (FSN).
FSN — Field Safety Notice (Thông báo an toàn trang thiết bị y tế) The communication sent to users and healthcare facilities detailing an FSCA — describing the problem, risk, and required user action.
GDP — Good Distribution Practice The set of standards ensuring medical devices are stored, transported, and distributed under conditions that maintain their quality and safety throughout the supply chain.
GMP — Good Manufacturing Practice The manufacturing quality standards required of medical device manufacturers. Evidenced in Vietnam through ISO 13485 certification or MDSAP.
IFU — Instructions for Use The document provided with a medical device explaining its intended purpose, correct use, contraindications, warnings, and maintenance. Must be in Vietnamese for devices sold in Vietnam.
IVD — In-Vitro Diagnostic device A medical device used to examine specimens derived from the human body (blood, tissue, urine, etc.) to provide diagnostic, monitoring, or screening information.
LoA — Letter of Authorisation The formal document by which a foreign manufacturer appoints a Vietnamese Authorised Representative, defining the scope of authority granted.
Marketing Authorisation (Đăng ký lưu hành) The registration pathway for Type C and D medical devices, requiring submission of a full technical dossier to DAV and a pre-market technical review before an authorisation number is issued. Valid for 5 years.
MDSAP — Medical Device Single Audit Program An international QMS audit program covering Australia, Brazil, Canada, Japan, and USA regulatory requirements. Recognised by DAV as equivalent to ISO 13485 certification for registration dossiers.
MOH — Ministry of Health (Bộ Y tế) The Vietnamese government ministry responsible for health policy, including issuing decrees and circulars on medical device regulation and overseeing DAV.
Nhãn phụ — Supplementary Label An additional Vietnamese-language label applied to imported medical devices or their packaging to meet the Vietnamese labelling requirement alongside the original foreign-language label.
Provincial Health Department (Sở Y tế) The health authority at provincial/municipal level in Vietnam. Receives notifications for Type A/B declarations, conducts local market surveillance, and coordinates with DAV on enforcement and FSCA activities.
PMS — Post-Market Surveillance The systematic collection and analysis of data on a device's safety and performance after it has been placed on the market.
PRISM The online registration portal used by Singapore's HSA — referenced for comparison; Vietnam's equivalent is DMEC.
SaMD — Software as a Medical Device Software that meets the definition of a medical device and is intended to be used for a medical purpose without being part of a hardware medical device.
Type A / B / C / D Vietnam's four-class risk-based device classification system, aligned with the ASEAN AMDD. Type A is lowest risk; Type D is highest risk.
UDI — Unique Device Identification A system of unique identifiers for medical devices enabling traceability through the supply chain. Vietnam is working towards UDI adoption in alignment with IMDRF guidance; implementation timelines are to be confirmed.