Medical Device Post-Market Surveillance in Southeast Asia

Manufacturers and their locally appointed dealers (aka economic operators) are required to carry out Post-Market Surveillance (PMS) of their medical devices in the ASEAN market to ensure the quality and evaluate the safety, performance, and effectiveness of medical devices. This means manufacturers and appointed dealers shall actively monitor those medical devices placed on the market in order to protect users and the final consumer (patient) of the medical device.

Medical Device Post-Market Surveillance in Southeast Asia

Indonesia, Malaysia, Vietnam, Thailand, Philippines, Singapore , Cambodia, and are all signatories to the ASEAN Medical Device Directive (AMDD), which was created to harmonise medical device legislation throughout Southeast Asia. Article 12 of the AMDD calls for member states (10 countries in total) to take all necessary steps to appropriately record and evaluate information regarding incidents involving a medical device placed on the market in their respective country, such as malfunction, deterioration, or inadequacy which may lead to or may have led to the death or serious deterioration of the health of a patient or user. This includes post-market surveillance activities to monitor the ongoing safety and effectiveness of the devices.

To do this member countries are required to set up a PMAS (Post Marketing Alert System) which should cover at least:

  • Importation and/or distribution records
  • Complaint records
  • Adverse Events (AE) reporting criteria and reporting format
  • Field Safety Corrective Action (FCSA) reporting format.
However, each ASEAN member is at liberty to legislate for a PMAS to suit their local requirements. To find out more about PMS requirements for manufacturers and locally appointed dealers in Singapore, Malaysia, Indonesia, the Philippines, Thailand and Vietnam click on the relevant country page below.

How Andaman Medical can help with your medical device post-market surveillance

With eight local offices throughout Southeast Asia, Andaman Medical provides support for post-market surveillance activities including adverse events and FSCA mandatory reporting. Our local, in-house staff liaise with the local medical device authorities to help you maintain compliance once your medical device is placed on the market.

Medical device post-market surveillance in Southeast Asian countries in the AMDD are predominantly reactive reporting as opposed to proactive customer surveys and Post Market Clinical Follow-up (PMCF) studies.

As part of good business practice as well as regulatory compliance elsewhere in the world, all manufacturers and their dealers shall develop, implement and maintain systematic procedures to proactively collect and review data gained from medical devices placed on the market in order to identify needs for Corrective and Preventive Actions (CAPA).

Our services include

Support for your mandatory reporting of Adverse Events and Field Safety Corrective Actions

Identify Southeast Asian requirements in medical device directives, standards, and guidance documents to ensure effective implementation of a post-market surveillance system

Evaluate your PMS data to ensure that existing processes and outputs are fully compliant

Monitor and report on any regulatory changes to ensure ongoing compliance

Why Choose Andaman Medical?

Get Expert Help Today

Contact us today to discuss how Andaman Medical can be your trusted partner for Medical Device Post Market Surveillance in Southeast Asia. Our experienced team is ready to help you achieve your commercial goals in this dynamic, fast-growing region.
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