不良事件报告与 FSCA：48 小时／10 天／30 天三档口径

1. Key takeaway

Under the post-market surveillance requirements of Annex 5 of the AMDD, adverse event (AE) reporting follows three timelines:

In addition: all adverse events should be reported as soon as possible; a Field Safety Corrective Action (FSCA) is initiated when the product owner needs to take action, including a recall, to eliminate or reduce the risk of an identified hazard — even if a device has left the market or been withdrawn, an FSCA may still be necessary as long as it may still be in use (for example, an implant).

One caveat: whether Cambodia has formally adopted these timelines in a domestic instrument could not be confirmed from official, publicly readable texts. This article follows the AMDD Annex 5 standard; in practice, the current requirements of the DDF prevail.

GRZAN note: AE reporting timelines fall into 3 tiers (48 hours/10 days/30 days); an FSCA may still be necessary for a device that has been withdrawn but may still be in use; the circulating claim of ”reporting within 15 days” has no official source and should not be relied on.

2. Regulatory basis

3. Expert commentary

1. The 48-hour tier is the one companies most often miss. It targets events ”posing a serious threat to public health”; the test points to population-level risk rather than individual outcomes. A single patient death falls into the 10-day tier; a batch defect capable of causing harm across a population falls into the 48-hour tier. Companies whose internal grading only asks ”whether anyone died” will systematically misjudge.

1. The scope of FSCA extends beyond products on sale. The AMDD wording is explicit: where a device has left the market or been withdrawn but may still be in use (for example, an implant), an FSCA may still be necessary. This is critical for implantable and long-life devices — a company cannot assume that the recall obligation ends when sales stop.

1. Neither the circulating claims of “annual update reports” nor of ”15-day reporting” could be located in official texts. When designing internal SLAs, companies should work from the three AMDD Annex 5 timelines and confirm with the DDF whether any additional local requirement exists, rather than adopting timelines that cannot be traced to a source.

4. Practical recommendations

1. Build the three tiers into a decision tree embedded in the quality system documentation. The first branch of the tree should be ”is this a serious threat to public health”, not ”has a death occurred”.
2. Maintain a long-term traceability ledger for implantable products. Record implanted batches and the facilities that can be contacted, so that an FSCA remains executable after the product has been withdrawn.
3. Agree reporting SLAs in the contract with the local authorised representative. Set internal turnaround times for each of the three tiers (for example, no more than 24 hours internally for the 48-hour tier) and make them auditable items.

5. Verification checklist

• □ Internal SLAs are set on the 48-hour/10-day/30-day three-tier basis
• □ The first branch of the severity test is ”is this a serious threat to public health”
• □ A long-term traceability ledger is in place for implantable products
• □ The FSCA process covers the ”withdrawn from the market but still in use” scenario
• □ Reporting SLAs are agreed in the contract with the local authorised representative
• □ No unattributed requirements such as ”15-day reporting” or ”annual update reports” have been adopted

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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