上市后监督：AMDD 第 12 条与上市后警报系统（PMAS）

1. Key takeaway

Article 12 of the AMDD requires member states to establish a Post-Market Alert System (PMAS). The events to be recorded are: device malfunction, performance degradation, and defects in labelling or instructions for use. The trigger is that these problems have caused or may cause death, or serious deterioration in health. Once recorded, the events must be assessed and notified between member states.

For Cambodia, this provision is both a regional harmonisation obligation and the technical framework for companies’ post-market duties. It makes one point clear: the obligations only begin on the day the registration certificate is obtained.

GRZAN note: PMAS covers 3 categories of recordable events (device malfunction, performance degradation, defects in labelling or instructions for use); the trigger has 2 conditions (has caused or may cause death, serious deterioration in health); and 2 follow-up steps (assessment, notification between member states).

2. Regulatory basis

3. Expert commentary

1. The trigger is phrased as ”may cause” — a forward-looking standard, not a retrospective one. Many quality management systems are built around ”reporting only after something happens”, but the wording of Article 12 is ”has caused or may cause death, or serious deterioration in health”. This means potential risks also fall within the reporting scope; a company cannot wait until harm has actually occurred before activating the process.

1. “Defects in labelling or instructions for use” are listed as a separate category alongside device malfunction. This point is often overlooked. Translation errors in the instructions for use, missing key warnings on labels, and inconsistencies between the Khmer and English versions are high-frequency problems in Cambodia’s multilingual environment and fall squarely within the PMAS recording scope.

1. ”Notification between member states” means that problems arising in Cambodia spill over. Once a notifiable event occurs in Cambodia, the information will be exchanged among ASEAN member states. For companies, this means a single local event can affect compliance status in other ASEAN markets, and vice versa. Companies operating in several countries should establish a unified ASEAN-level vigilance process rather than running one process per country.

4. Practical recommendations

1. Establish a single PMAS process document covering every ASEAN country of operation. The process should define: event identification → severity assessment → timeline control → reporting recipients (the DDF and the local authorised representative) → investigation and correction → record retention.
2. Write ”labelling and instructions-for-use defects” explicitly into the event identification checklist. In a multilingual market, this category occurs more often than pure device malfunction.
3. Appoint a single accountable owner and interface with the local authorised representative. The post-market chain is the longest and the one most easily broken — teams that only handle one-off imports and arrange no follow-up monitoring tend to fail here.

5. Verification checklist

• □ PMAS process documents covering ASEAN have been established
• □ The event identification checklist includes all three categories: device malfunction, performance degradation, and defects in labelling or instructions for use
• □ The severity criteria adopt the forward-looking ”has caused or may cause” standard
• □ Reporting recipients are clearly defined as the DDF and the local authorised representative
• □ A single accountable owner has been appointed
• □ Record retention and traceability mechanisms are in place

Regulatory information verified as of 29 October 2026.

In Southeast Asia, GRZAN’s core capabilities focus on three areas. First, tracking the legislative progress of dedicated medical device laws across member states — Singapore, Malaysia, Thailand, Indonesia, the Philippines and Vietnam have each established written device regulatory frameworks, whereas Cambodia still has no dedicated Medical Device Law. The current rules are assembled from three layers: the legal basis for registration numbers provided by the 1996 Law on the Management of Pharmaceuticals and its 2007 amendment, the classification and procedures provided by Prakas No. 1258 of 2012, and the technical framework of the ASEAN Medical Device Directive. Regulatory certainty is therefore markedly lower than in markets that have completed legislation. Second, local authorised representative services: GRZAN may act as the manufacturer’s statutory representative in Cambodia, carrying registration submissions, regulatory communication and post-market reporting obligations, and assisting with the practical implementation of the Cambodian registered pharmacist and pharmaceutical import/export enterprise licence requirements. Third, quality system and testing support: assisting with the establishment of a quality management system meeting ISO 13485 requirements, and organising the technical dossier in accordance with the ASEAN Common Submission Dossier Template (CSDT).

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