Medical Device Registration in Vietnam
Ministry of Health
Regulatory Authority
Department of Medical Equipment and Construction (DMEC)
Medical Device Regulation
Decree No. 98/2021
Official Language
Vietnamese
Classification
Class A, B, C & D
Medical Device Registration in Vietnam
- Determine the device classification
- The Authorised Representative, known as Registration Holder, must file for Market Authorization (MA) License
- For Class A, B – Review of technical documents by the DMEC. Once approved, a registration number will be issued.
- For Class C, D
- Countries without prior approval from either USA, Canada, Europe, Japan, China, Korea or Australia will be subjected to Technical Review. A country with prior marketing authorization may not be subjected to Technical Review
Documents Required
- Application Form
- Registration Dossier in Common Submission Dossier format
- Letter of Authorization
- Power of Attorney
- Technical Documents
- Prior marketing authorizations (if any)
- Labels, IFUs or User Manual
Post-market Requirements
Decree 36, Article 30 – 36
Decree 169, Article 1
Legalized/Notarised Documents (if any)
Letter of Authorization
Applicable QMS
ISO 13485
Registration Timeline
Class A, B – 60 days
Class C, D – 90 days
Authorized Representative
Yes. Registration Holder
License Validity
MA License does not expire
Special Notes
- IFUs or Labels should be in Vietnamese or English
- Complaint labelling may be affixed after Customs clearance