Association of Southeast Asian Nations, or ASEAN, is a political and economic union of 10 members states in Southeast Asia, which are Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam.
As part of its commitment to harmonizing risk classifications across the Association of Southeast Asian Nations (ASEAN), Malaysia's Medical Device Authority (MDA) has published a list of risk classifications for medical devices, including in-vitro diagnostics (IVDs).
The ASEAN Medical Device Directive (AMDD) aims to harmonize medical device regulations among ASEAN countries. On 23 April 2020, Malaysia signed this Agreement, which entered into force on 1 January 2015.
The purpose of this document is to provide guidance to manufacturers and authorised representatives regarding the risk classification of medical devices, including in-vitro diagnostic (IVD) medical devices which have been harmonised in ASEAN.
Based on their intended use/purpose, this guidance document provides the harmonised list of risk classifications for medical devices, including in-vitro diagnostic (IVD) medical devices.
Click on this LINK to know more about the list of harmonised risk classification of identified medical devices that are listed in Annex A of this guidance.