ABSTRACT
The regulatory body in Vietnam is the Department of Medical Equipment and Construction (DMEC), under the Ministry of Health. The classification of medical devices based on the risk level is being developed in Vietnam. It mainly follows the Association of Southeast Asian Nations (ASEAN) Medical Device Directives (AMDD)/Global Harmonization Task Force (GHTF) recommendations. The Classification Guidance is stipulated in Circular 39/2016/ TT-BYT dated 28 October 2016. The content of Circular 39 follows the AMDD guidance for classification. The Medical Device Administration Control System is divided into two parts: notification for MD Class A; and pre-market Approval for MD Class B, C, and D. Vietnam follows International Organization for Standardization (ISO) 9001, ISO 13485:2003 and Vietnam's National Standards (TCVN). It is voluntary to follow and not compulsory. Medical device labeling should comply with the regulations of Decree No. 89/2006/ND-CP of the Government on labeling of goods. The requirements on local manufacturing have been developed based on ISO 9001 and ISO 13485.
