Medical Device Registration in Vietnam


Ministry of Health

Ministry of Health

Regulatory Authority

Department of Medical Equipment and Construction (DMEC)

Medical Device Regulation

Decree No. 98/2021

Official Language



Class A, B, C & D

Registration Process

  • 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

Want to know more about this registration process?