Consulting process for product registration/announcement

DRUG REGISTRATION

Receiving authority: Drug Administration of Vietnam – Ministry of Health

Dossier requirements:

  • Part I: Administrative dossier
  • Part II: Quality dossier (ACTD or CTD format)
  • Part III: Preclinical dossier (if necessary)
  • Part IV: Clinical dossier (if necessary)

HEALTH SUPPLEMENT FOOD DECLARATION

Receiving authority: Food Safety Administration – Ministry of Health

Dossier requirements:

  • Product declaration form
  • Certificate of Free Sale
  • GMP certificate (or equivalent)
  • Product standard specification
  • Test result sheet
  • Product sample

MEDICAL DEVICE REGISTRATION

Receiving authority: Department of Health, Medical Equipment and Infrastructure Management Department – Ministry of Health

Categorization:

  • Group 1: Medical devices Type A, B – Standard compliance publication
  • Group 2: Medical devices Type C, D – Product circulation registration

COSMETIC PRODUCT DECLARATION

Receiving authority: Drug Administration – Ministry of Health

Dossier requirements:

  • Business registration certificate
  • Power of Attorney
  • Certificate of Free Sale (CFS)