临床证据：B/C/D 类的差异化深度要求

1. Key takeaways

CSDT Module D (summary of design verification and validation documents) contains preclinical studies and clinical evidence, and states expressly that the level of detail of clinical evidence depends on the device class (Class B, C or D). Cambodia therefore treats clinical evidence on a risk-escalating basis rather than one size fits all.

Following the general risk-escalation logic and consistent practitioner reporting:

GRZAN note: clinical evidence depth escalates across 4 classes; Module D’s 2 components are preclinical studies and clinical evidence; Cambodia’s position within ASEAN is to reference the classification outcomes of other ASEAN jurisdictions, but DDF retains the right to re-classify.

2. Legal basis

3. Expert insights

1. Cambodia has published no tiered clinical evidence thresholds; this is a gap that must be filled with other evidence. Markets such as Thailand and Malaysia specify in which cases local clinical investigations are needed; Cambodia has no published rules of this kind. The workable practical route is to use registration outcomes in other ASEAN jurisdictions and review documentation from reference markets (FDA, EMA, TGA and others) as the main sources of clinical evidence; the feasibility of running local clinical investigations in Cambodia is usually very low.

1. Leveraging other countries’ approvals is valuable in Cambodia, but it is not an exemption. Consistent practitioner reporting indicates that where a product already holds registration in core ASEAN members such as Thailand, Malaysia, Singapore or Indonesia, and that registration was based on review of the ASEAN common dossier, some documents may be accepted by DDF, shortening local review. Note, however, that this is a review facilitation, not a statutory exemption channel; DDF retains full review and re-classification powers.

1. The quality of reference-market evidence determines the number of deficiency rounds. Translating the clinical evaluation sections of an FDA 510(k) or an EU CE technical file and submitting them as they stand often fails to match the Module D structure. The correct approach is to reorganise the material to Module D: list preclinical studies first, then clinical evidence, and explain how each maps to the device’s intended use.

4. Practical recommendations

1. Prefer the combined route of “equivalence comparison + reference-market review documentation”. First build the equivalence argument with comparable devices already on the market, then add reference-market approval documents and published review reports. This combination enjoys higher acceptance in Cambodia than a single source.
2. Budget time and money for clinical data for Class D implantable products. Although Cambodia imposes no written requirement for local clinical investigations, high-risk implantable products are in practice often asked for more complete clinical data; budget on a “may be required” basis.
3. Keep clinical evidence strictly aligned with the intended use. The “most critical intended use” highlighted in article 08 determines the class, and therefore the depth of clinical evidence. If the intended use in the instructions for use is written more broadly than the clinical evidence supports, the review will inevitably require narrowing or supplementary data.

5. Verification checklist

• □ Depth of clinical evidence confirmed for Class A/B/C/D
• □ Module D lists preclinical studies and clinical evidence separately
• □ Equivalence argument with comparable devices on the market established (where applicable)
• □ Reference-market approval documents and review documentation collected
• □ Intended use covered by the clinical evidence consistent with the instructions-for-use wording
• □ Budget and time reserved for supplementary clinical data for Class D implantable products

Regulatory information verified as of 29 October 2026.

In Southeast Asian markets, GRZAN’s core capabilities concentrate on three points. First, distinguishing 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 registration-number legal basis provided by the 1996 Law on Drug Management 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. Compliance certainty is therefore markedly 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 submission, regulatory communication and post-market reporting obligations, and assisting with the practical requirements for a Cambodian registered pharmacist and a drug import-export enterprise licence. Third, quality system and testing support: helping establish a quality management system that meets ISO 13485 requirements and organising the technical dossier under the ASEAN Common Submission Dossier Template (CSDT).

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