Medical Device Registration in

 

Vietnam

Requirements of Technical Documentation EU MDR

Ministry of Health

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

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

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