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Laos

Medical Device Registration in Laos

Ministry of Health: 

Ministry of Health

Regulatory Authority:       

The Food and Drug Department (FDD)

Medical Device Regulation:

ASEAN Medical Device Directives

Drug and Medical Product Law

Official Language:   

Lao

Classification:        

A, B, C, D

Registration Process:       

  • Determine the device classification
  • Appoint authorized representative
  • Prepare the Technical Documents
  • Submit the application form and technical documents to the FDD
  • Once approved, the device can be marketed in Laos

Documents Required:      

  • Application Form
  • Common Submission Dossier
  • Product Information
  • Commercial marketing history
  • Labelling and Package Insert
  • List of Regulatory Approvals
  • Safety and performance-related information
  • Clinical Studies
  • Risk Analysis
  • Manufacturing Process
  • Post Marketing Alerts System (PMAS)
  • Declaration of Conformity

Post-market surveillance: 

  • Serious Threat to public health – 48 hours
  • Death or serious deterioration in the state of health – 10 days
  • Adverse event reoccurrence which may lead to death or serious deterioration – 30 days

Applicable QMS:    

GMP or ISO 13485

Authorized Representative:        

Yes

Want to know more about this registration process?