Medical Device Registration in
Laos
Ministry of Health:
Regulatory Authority:
The Food and Drug Department (FDD)
Medical Device Regulation:
ASEAN Medical Device Directives
Official Language:
Lao
Classification:
A, B, C, D
Medical Device Registration in Laos:
- 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