Classification Under the AMDD Incorporating elements from the European Union’s Medical Device

Classification Under the AMDD
Incorporating elements from the European Union’s Medical Device Directives (MDD 93/42/EEC) and Global Harmonization Task Force (GHTF) recommendations, the AMDD would set up a four-tier classification system for medical devices and in-vitro diagnostic devices for all 10 ASEAN member states:

• Class A: low-risk devices;
• Class B: low-moderate-risk devices;
• Class C: moderate-high-risk devices; and
• Class D: high-risk devices.

The in-vitro diagnostic devices classification is based on the GHTF guidance. The AMDD would give member states’ regulatory agencies the authority to issue final classification rulings on devices in instances where disputes regarding proper classification arise. Any member state’s medical device market regulator that applies AMDD classification rules differently than prescribed will be required to explain its actions to the ASEAN Medical Device Committee.