Medical Device Regulatory Requirements in Vietnam
| Regulatory Authority |
Department of Medical Equipment and Health Works (DMEHW) |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
A,B,C,D |
| Medical Device Regulations |
No: 98/2021/ND-CP Decree on Medical Equipment
| Click Here
|
| IVD Classification |
A,B,C,D |
| Registration Process |
Medical Device Registration
| Click Here
|
| Registration Timeline |
For class A and B, it takes 1 to 2 weeks and for class C and D, it takes 6 to 10 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in English & Vietnamese Or
French & Vietnamese Language |
| Additional Information |
Medical equipment with a circulation number in Vietnam can be exported and imported according to need, without quantity restriction and without approval from the Ministry of Health. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025