What is AMDD?
The ASEAN Medical Device Directive (AMDD) is a harmonized medical device regulation applicable across the ASEAN countries.
The Association of Southeast Asian Nations (ASEAN) has signed the ASEAN agreement on medical device directive accepting the AMDD.
The ASEAN countries includes, Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam.
In Which Countries is the AMDD Valid?
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Singapore, Malaysia, and Indonesia are in advance stages and have fully complied with the AMDD
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The Philippines, Thailand, and Cambodia have revised their national regulations to comply with certain requirements of the directives. More changes are yet to be made to fully comply with the AMDD
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Laos and Myanmar are in the process of establishing new regulations
Compliance | Countries |
|---|---|
Fully Compliant | Singapore, Malaysia, Indonesia |
Largely Compliant | Brunei Darussalam, Vietnam |
Partially Compliant | The Philippines, Cambodia, Thailand |
In Development | Laos, Myanmar |
How are Medical Devices Classified under the AMDD?
The medical devices are classified into four (4) classes by the AMDD based on their risk levels. The risk levels increase from Class A to Class D.
Class | Risk Level |
|---|---|
A | Low Risk |
B | Low – Moderate Risk |
C | Moderate – High Risk |
D | High Risk |