Overview

Vietnam’s Medical Device market is picking up over the years and is currently one of the booming sectors in the country. Medical Devices in the country are regulated by Department of Medical Equipment and Health Works (DMEHW) under Ministry of Health. The devices are classified into 4 classes (A, B, C and D) which are also categorized into two groups, group 1 (Class A) and group 2 (Class B, C and D). Appointment of reliable and capable Vietnamese agent for foreign manufacturers is crucial as they must undertake the warranty services offered by manufacturer as part of the device sale. Translation to Vietnamese is a must to enter the region, which indeed can be challenging in actual practice.

Freyr offers Regulatory support extending the complete range of activities such as procuring Free-sale Recognition Number involved in medical device approval from authorities. We also provide linguistic expert support to maintain the Regulatory perspective of the translation intact. We cater to the post-approval needs of clients to maintain compliance throughout product lifecycle in Vietnam. 

Vietnam Market Entry for Medical Devices - Process Flow