Device Description and Intended Use: CSDT Module C

1. Key takeaways

CSDT Module C (Device Description) requires full disclosure of the device itself and its intended use, covering at least 12 items: device description and characteristics, intended use, indications for use, instructions for use, contraindications, warnings, precautions, potential adverse effects, alternative therapies, materials, other relevant specifications, and other descriptive information.

This module links directly to the classification discussed in article 08 of this series — intended use is the classification criterion, so the intended-use wording in Module C must be exactly consistent with the labelling, the instructions for use and the promotional material.

The 12-item list also functions as a completeness contract for the rest of the dossier. Several items — contraindications, warnings, precautions, potential adverse effects — reappear in later modules in evaluated form, and the instructions-for-use item is the carrier through which the same information reaches the user. Writing Module C first, as the single controlled source of these statements, and deriving the later modules from it, is the cleanest way to keep the wording identical everywhere; drafting each module independently is the surest way to accumulate small divergences that reviewers then have to reconcile.

GRZAN note: Module C covers at least 12 items; intended use is the classification criterion under Article 4(4) of the AMDD and must keep the same text across 3 carriers (Module C, labelling and instructions for use).

2. Legal basis

3. Expert insights

1. Intended use is a legal variable in Cambodia, not marketing copy. AMDD Article 4(4) places the classification of a multi-purpose device on the ‘most critical intended use’, and the source of intended use is ‘the data provided by the product owner in the instructions for use’ together with ‘the functional capability of the device’. Every word written in Module C can therefore determine the class, the depth of clinical evidence and the review duration. The wider use the marketing team wants and the narrower use the regulatory team wants must converge into a single version here.

1. Contraindications, warnings, precautions and potential adverse effects are the device version of product safety information. These four items correspond to the safety section of a pharmaceutical package leaflet. Having brought devices into pharmaceutical-style regulation, Cambodia gives these four items noticeably more weight in review than purely device-focused markets. Missing any one of them may trigger a deficiency request.

1. The ‘materials’ item is especially critical for implantable and body-contacting products. The materials statement should close the loop with the subsequent biocompatibility evaluation (article 26 of this series): Module C lists the material inventory, and Module D and the supporting documents provide the corresponding biological evaluation evidence. Material names and grades must be written identically in both places.

1. Alternative therapies is an item many device teams leave thin, and it deserves more care. The item asks what a clinician would use if this device were not available, and answering it honestly does two things at once: it situates the device in the existing treatment landscape, and it implicitly defines the population for whom the claimed benefit matters. A generic answer suggests the intended-use statement was not thought through, and reviewers who find the alternatives description vague tend to re-read the intended-use wording with more suspicion — which matters because intended use is the classification criterion.

1. The interaction between Module C wording and review duration deserves explicit planning. Because intended use drives the class, any wording that can be read as broader than the evidence supports creates a choice for the reviewer: either treat the broader reading as intended and ask for deeper evidence, or ask the applicant to narrow the wording. Both outcomes cost time, and the second one additionally touches the labelling, the instructions for use and the promotional material, all of which must then be re-aligned to the narrowed text. Drafting the intended use at the narrowest commercially defensible scope, and widening it only where evidence already exists, avoids this loop.

4. Practical recommendations

1. Make the intended-use text a controlled document under numbered management. Every change must pass regulatory review and be updated simultaneously in Module C, the labelling, the instructions for use and the promotional material.
2. Give each of the 12 items its own sub-heading and leave none blank. For items that do not apply, state ‘not applicable’ with the reason, so the dossier is not judged as having missing items; an absent heading looks like an omission, while a stated reason shows the item was considered.
3. Cross-reference the material list with the biocompatibility report. Under the materials item, note ‘biological evaluation: see report XX’ to create a traceable chain.

5. Verification checklist

• □ All 12 items of Module C completed (non-applicable items state the reason)
• □ Intended-use text aligned with the labelling, instructions for use and promotional material
• □ Class A/B/C/D outcome re-checked against the intended use
• □ Contraindications, warnings, precautions and potential adverse effects all present
• □ Material list cross-referenced with the biocompatibility report
• □ Intended-use text managed as a numbered controlled document

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 Act; the current rules are pieced together from three layers: the registration-number legal basis provided by the Law on Drug Management 1996 and its 2007 amendment, the classification and procedures provided by Prakas No. 1258 (2012), and the technical framework provided by the ASEAN Medical Device Directive, so compliance certainty is 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, handling registration submissions, regulatory communication and post-market reporting obligations, and assisting with the practical arrangements for a Cambodian registered pharmacist and the licence for pharmaceutical import and export enterprises. Third, quality-system and testing support: GRZAN assists in establishing a quality management system conforming to ISO 13485 and in organising the technical dossier under the ASEAN Common Submission Dossier Template (CSDT).

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