A/B/C/D 四档分级：附件 2 与附件 3 该怎么选

1. Key Takeaway

Under Article 4 of the AMDD, Cambodia classifies medical devices into four classes: Class A (low risk), Class B (low-to-moderate risk), Class C (moderate-to-high risk) and Class D (high risk). The classification rules are not in the body of the Directive but in the annexes — Annex 2 governs non-in vitro diagnostic devices and Annex 3 governs in vitro diagnostic (IVD) devices.

The typical distribution across the four classes:

GRZAN note: Cambodia’s classification is A, B, C and D — 4 classes in total, with the rules spread over 2 annexes; it is not the Class I/II/III scheme and not the I/IIa/IIb/III scheme.

2. Regulatory Basis

3. Expert Commentary

1. Choose the annex first, then apply the rules — this is the step where errors are most likely. IVDs and non-IVDs follow two entirely different classification logics. Classifying an IVD under Annex 2, or treating a device with testing functions under Annex 3, both produce a wrong class. The decision sequence is: is the product an IVD (providing information by in vitro examination of human specimens) → select the annex → apply the rules → obtain the class.

1. Cambodia does not accept group registration of products; classification granularity must reach model level. Devices with different trademarks, different artwork, different sizes or different manufacturing sites must be registered separately in Cambodia. This means every SKU in one product family may need its own classification and its own dossier — a workload not comparable with markets where “one dossier covers the whole family”.

1. The DDF retains the power to reclassify. Although Cambodia generally follows the classification outcomes of other ASEAN jurisdictions, the DDF has the power to reclassify during review. The classification conclusion therefore cannot stay in internal documents; it must be submitted as part of the technical dossier, stating the intended purpose relied on and the rule entries applied.

4. Practical Recommendations

1. Write the classification conclusion as a stand-alone document. Include: product name and model, the original wording of the intended purpose, the applicable annex (2 or 3), the specific rule entries applied, and the final class. This document is both part of the dossier and the baseline for later change comparisons.
2. Size the workload by model count at the quotation stage. Because grouping is not allowed, a product family of 20 SKUs represents a workload in Cambodia close to 20 separate registrations. Decision-makers must be told this clearly at project initiation.
3. Keep one class of headroom in the documentation. If the product sits on a class boundary (for example between B and C), prepare the technical documentation to the higher class to avoid deficiencies if the DDF reclassifies.

5. Verification Checklist

• □ Determined whether the product is an IVD or non-IVD and selected Annex 2 or Annex 3
• □ Derived the A/B/C/D class from the rule entries of the selected annex
• □ Classification conclusion issued as a stand-alone document and included in the technical dossier
• □ SKUs requiring registration listed model by model, with no grouping assumption
• □ Possibility of DDF reclassification assessed and documentation depth reserved at the higher class
• □ Project quotation sized by model count rather than product family count

Regulatory information verified as of 29 October 2026.

In Southeast Asia, GRZAN’s core capabilities concentrate on three areas. First, distinguishing the legislative progress of dedicated medical device laws across member states — Singapore, Malaysia, Thailand, Indonesia, the Philippines and Vietnam have each established a written device regulatory framework, whereas Cambodia still has no dedicated Medical Device Law; its current rules are assembled from three layers — the registration-number legal basis 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 provided by the ASEAN Medical Device Directive — leaving regulatory certainty materially lower than in markets that have completed legislation. Second, local authorised representative services: GRZAN can act as the manufacturer’s statutory representative in Cambodia, undertaking registration submissions, regulatory communication and post-market reporting obligations, and assisting with the practical implementation of the Cambodian registered pharmacist requirement and the pharmaceutical import and export enterprise licence. Third, quality system and testing support: helping establish a quality management system meeting ISO 13485 requirements and organising the technical dossier according to the ASEAN Common Submission Dossier Template (CSDT).

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