Vietnam medical device and IVD regulatory framework
Medical devices and IVDs sold in Vietnam are regulated by the Infrastructure and Medical Device Administration (IMDA) under the Ministry of Health (MOH). Current regulations governing the medical device registration were issued in 2021, namely Decree No. 98/2021 (link in Vietnamese), Circular No. 05/2022, and the revised Decree No. 07/2023/ND-CP, which revised Decree No. 98/2021/ND-CP. Vietnam’s medical device regulatory scheme is informed by the ASEAN Coordination Guidelines and the ASEAN Medical Devices Directive.
Regulatory pathways for medical devices and IVDs in Vietnam
IMDA has established two registration pathways to obtain a Marketing Authorization (MA) license based on classification. Medical devices and IVDs are categorized into four tiers based on increasing risk: Class A, B, C, and D.
Low-risk products that are Class A or B follow a notification process that requires a Declaration of Applied Standards application, which is reviewed by your MAH’s provincial MOH office. Class C and D devices must undergo a full technical review of a Marketing Authorization Registration application under the MOH.
While reference market approval is not required, it can fast track your application. Acceptable reference markets include GHTF member countries (USA, Canada, Europe, Japan, or Australia) as well as China, South Korea, and Switzerland. Class A and B notifications are also expedited with reference market approvals, with many authorizations processed in less than one week.
Additional medical device and IVD regulatory requirements in Vietnam
All devices imported by foreign manufacturers must appoint a local representative, known as a Marketing Authorization Holder or MAH. Your MAH is responsible for submitting the MA application to IMDA online system, acting as your liaison with IMDA during the application review, issuing Letters of Authorization for distributors and importers.
