Ministry of Health: 

Ministry of Health

Regulatory Authority:       

Department of Drugs and Food (DDF)

Medical Device Regulation:

ASEAN Medical Device Directive (AMDD)

Official Language:   

Khmer

Classification:        

Class A, B, C and D

Registration Process:     

• 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.

Documents Required:      

• Executive Summary
• Relevant Essential Principles
• Declaration of Conformity
• Device Description
• Summary of Design Verification and Validation
• Device Labelling

Post-market surveillance: 

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)

Applicable QMS:   

ISO 13485

Registration Timeline:      

6 – 12 months

Authorized Representative:        

Yes. Local Representative.

License Validity:     

3 years

Special Notes:       

Labelling should be in local language, Khymer.