Design Verification and Validation Summary: CSDT Module D

1. Key takeaways

CSDT Module D is the summary of design verification and validation documentation and contains 2 parts: preclinical (non-clinical) studies and clinical evidence. The text states explicitly: the level of detail required for the clinical evidence depends on the device class (Class B, C or D).

Module D is positioned as a ‘summary’, not the full record — it requires the verification and validation work to be condensed into conclusive documents fit for review, pointing to the detailed, traceable reports elsewhere in the dossier.

Reading Module D as a summary also clarifies what belongs in it and what does not. Raw instrument readouts, full test protocols and laboratory worksheets belong in the referenced reports; what Module D owes the reviewer is the decision-relevant layer: what was tested, against which method, what was observed, and what the observation means for conformity. This division of labour protects the reviewer’s time and, equally, protects the applicant — a summary with explicit pointers is easy to defend under questioning, because every claim in it can be traced to a report that says more.

GRZAN note: Module D contains 2 parts (preclinical studies, clinical evidence); the depth of clinical evidence increases across the 3 higher classes (B/C/D); the module is a ‘summary plus traceable pointers’, and 1 conclusive document must be able to point to all detailed reports.

The class-dependence of the clinical-evidence depth is worth planning at project level rather than at writing level. The same device submitted under different classes would carry different clinical burdens, so the class determination effectively fixes the size of this module before drafting begins. Teams that draft Module D before the class is settled often find the clinical part must be rebuilt; teams that settle the class first can size the clinical section to the requirement and assemble the underlying reports in parallel.

2. Legal basis

3. Expert insights

1. The ‘summary’ positioning dictates the writing style, not the length. Module D does not need the full text of every test report, but it must give, for each verification and validation activity, the purpose, method, results and conclusion, plus the number of the detailed report. Poor execution usually takes one of two extremes: writing only ‘test XX completed’ with no conclusion, or stuffing in the full text of every report so reviewers cannot extract conclusions.

1. Preclinical studies carry more weight in Cambodia than in many markets. Because local clinical investigations are hardly feasible, reference-market data and approvals elsewhere are the primary evidence sources, so the completeness of the preclinical studies (performance, electrical safety, electromagnetic compatibility, biocompatibility, sterilisation, stability) becomes the part of the Cambodian review that best demonstrates product quality. Make this part solid.

1. For active devices, electrical safety and software verification deserve their own sections in this module. The declaration of conformity and test reports for the IEC 60601 series, and the software lifecycle documentation under IEC 62304, should have dedicated sub-sections in Module D with version identifiers. Software version identification matters most — it must prove that ‘the software version sold in Cambodia’ is identical to ‘the verified version’.

1. The order in which the two parts are presented should mirror the review logic. Preclinical evidence establishes what the device does under controlled conditions; clinical evidence then establishes what that means for patients in the intended use. Presenting preclinical results first, and letting the clinical part refer back to them, allows the reviewer to accumulate confidence in one direction instead of jumping between evidence types. Reversing the order, or interleaving the two, makes the module harder to follow and increases the chance that a link the applicant considers obvious is missed.

1. Stability and sterilisation results deserve the same four-line treatment as every other activity. They are sometimes pushed into adjacent modules or annexes, on the assumption that these specialised topics have their own home elsewhere in the dossier. The consequence is that Module D no longer summarises all verification and validation work, and a reviewer compiling the evidence chain from the summary alone finds gaps that are actually cross-references. Keeping every activity visible in the summary, with pointers out to wherever the detail lives, preserves the module’s function as the single entry point to the evidence.

4. Practical recommendations

1. Record each verification and validation activity in a four-line entry: purpose / method (with standard numbers) / results / conclusion and report number. A uniform format lets reviewers build the evidence chain quickly.
2. Tailor the depth of clinical evidence to the class but keep room to upgrade. Class B relies mainly on comparison with equivalent devices; Class C adds a complete clinical evaluation report; Class D and implantable products should budget for clinical investigation data.
3. Maintain a version cross-reference table for active and software products. Put the software version numbers, release notes, verification report numbers and the version sold in Cambodia on a one-page table and submit it with Module D.

5. Verification checklist

• □ Module D lists preclinical studies and clinical evidence as separate parts
• □ Each verification and validation activity recorded in the four-line format (purpose/method/results/conclusion + report number)
• □ Depth of clinical evidence tailored to Class B/C/D
• □ Active devices provide IEC 60601 series conformity evidence
• □ Software products have a version cross-reference table (version sold = verified version)
• □ All detailed reports cited in the summary are locatable in the dossier

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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