投诉处理与进出口记录：经销商的四项法定义务

1. Key takeaway

Companies distributing medical devices and IVDs in Cambodia bear four statutory obligations:

1. Keep complete import and export records;
2. Hold valid product registration certificates;
3. Keep complaint records;
4. Report adverse events (AEs) and Field Safety Corrective Actions (FSCAs) to the DDF and to the local authorised representative (LAR), and comply with Good Distribution Practice (GDP).

These four obligations connect to the PMAS requirement of AMDD Article 12: import and export records underpin traceability, complaint records underpin event identification, and AE/FSCA reporting underpins notification obligations.

GRZAN note: there are 4 distributor obligations in total; reporting runs in both directions to 2 recipients (the DDF and the local authorised representative); there are 2 types of records (import/export records and complaint records).

2. Regulatory basis

3. Expert commentary

1. “Dual reporting to the DDF and the local authorised representative” is an action that is easily missed. Companies usually engage only the party they know best. But the LAR is the in-country legal channel of the product owner, while the DDF is the regulator, and their information needs differ — the LAR needs prompt escalation to meet its obligations under Article 1, paragraph 2, and the DDF needs prompt awareness to launch the assessment and notification under Article 12. Missing either direction breaks the chain.

1. Import and export records are the technical foundation of traceability in Cambodia. Because Cambodia does not allow product grouping and every model must be registered separately, import and export records must be able to pinpoint the specific model and batch. A ledger that records only product names and quantities cannot support a targeted recall when an event occurs.

1. Making the pharmacist responsible for “storage and distribution” gives records management an internal owner. Article 4 (new) of the amendment law places the responsibility for storage and distribution on a Cambodian registered pharmacist. Designating import/export records, temperature and humidity logs and batch traceability records as pharmacist sign-off documents both satisfies the regulator and keeps the chain of responsibility clear.

4. Practical recommendations

1. Write the four obligations into distribution agreements and make them auditable items. In particular, dual AE/FSCA reporting should carry agreed reporting timelines (following the three tiers in article 42) and contractual liability for failure to report.
2. Design import and export records around five elements: model + batch + quantity + counterparty + date. This ensures that a targeted recall can be supported.
3. Connect the complaint handling process to the vigilance process. Complaints are the main entry point for event identification; define clear escalation criteria — which complaints must move into the AE assessment process.

5. Verification checklist

• □ The four statutory obligations are written into distribution agreements
• □ Import and export records follow the five-element design: model + batch + quantity + counterparty + date
• □ Complaint records are established, with escalation criteria towards AE assessment
• □ Dual AE/FSCA reporting (DDF + LAR) processes are in place
• □ GDP compliance requirements are included in distributor management
• □ Records are within the pharmacist’s sign-off scope

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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