Learning Marketplace

ASEAN Medical Device Directive (AMDD) A brief Overview

Southeast Asian markets have been attracting more attention of foreign medical device manufacturers for its developing economy and increased demands on healthcare.

Recently The Association of Southeast Asian Nations (ASEAN) - a regional trade group encompassing Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam - has developed the ASEAN Medical Device Directive (AMDD) in order to create a more predictable and consistent path to market.

By setting up a harmonised system for medical device registration throughout Southeast Asia, it potentially creates a compelling new medical device market with a geographic area with 600 million people.

This webinar will cover:

  • Background of ASEAN Medical Device Directive;
  • Key elements of the ASEAN AMDD;
  • Impact on current registration system;
  • Steps foreign manufacturers can take now to prepare for compliance.

Presenter

Dr Liang Qian is the Head of Medical Device, APAC at BSI. She is responsible for the BSI Medical device stream in the Asia Pacific Region.

Dr Liang Qian was a fully qualified Technical file reviewer for reviewing design dossier and technical file for orthopaedic implants and instruments to European Medical Device Directive.