Placing a device on the market in Southeast Asia carries ongoing regulatory responsibility. Post-market surveillance (PMS) is a formal requirement for manufacturers and their appointed local dealers (economic operators), providing a framework to monitor safety, evaluate incidents, and maintain compliance throughout the product lifecycle.

Indonesia, Malaysia, Vietnam, Thailand, the Philippines, Singapore, Cambodia, and other ASEAN member states are signatories to the ASEAN Medical Device Directive (AMDD), established to harmonize medical device legislation across the region.

Article 12 of the AMDD requires all ten member states to record and evaluate incidents involving devices placed on their markets, including malfunctions, performance deterioration, labeling or instruction inadequacies, or other issues that have led or could lead to death or serious deterioration of a patient’s or user’s health. These obligations form the basis of post-market surveillance activities regionally.

To comply, each member state must implement a Post Marketing Alert System (PMAS) to monitor ongoing safety and effectiveness.

At Andaman Medical, we manage structured PMS activities across ASEAN markets, from complaint handling and incident evaluation to adverse event reporting and Field Safety Corrective Action coordination, ensuring your post-market obligations are fulfilled in accordance with national requirements.