Medical Device Registration in
Ministry of Health:
Department of Drugs and Food (DDF)
Medical Device Regulation:
ASEAN Medical Device Directive (AMDD)
Class A, B, C and D
- Determine the classification of the device
- Appoint a local representative
- Prepare application and Technical File
- Make the fee payment.
- Once approved, the manufacturer may market your device.
- Executive Summary
- Relevant Essential Principles
- Declaration of Conformity
- Device Description
- Summary of Design Verification and Validation
- Device Labelling
Serious threat to public health – 48 hours
Death or serious deterioration in health – 10 days
An event where recurrence might lead to death – 30 days
Legalized/Notarised Documents (if any)
Declaration of Conformity (DoC)
6 – 12 months
Yes. Local Representative.
Labelling should be in local language, Khymer.