Executive Summary Writing: CSDT Module A

1. Key takeaways

CSDT Module A (Executive Summary) is the first document a reviewer opens in the dossier and must contain 6 elements:

1. Overview — an introductory description of the device, its intended use and indications for use, any novel features, and a summary of the CSDT contents;
2. Commercial marketing history;
3. Intended use and indications as stated in the labelling;
4. List of regulatory approvals or marketing authorisations already obtained;
5. Status of any marketing authorisation applications pending approval;
6. Significant safety or performance-related information.

GRZAN note: the executive summary carries 6 mandatory elements; element 4 (list of approvals obtained) and element 5 (status of pending applications) are the direct basis on which the Cambodian review judges ‘reference-market evidence’.

The order of the six elements is also a reading order for the reviewer. Module A is written to be read alone: a reviewer who opens only the executive summary should be able to reconstruct what the product is, where it has been approved, what is still pending and what safety issues exist, without turning to other modules. That is why the CSDT asks the overview to summarise the CSDT contents as well — the summary doubles as a map of the dossier. Writing Module A as an afterthought, copied from a brochure or from a submission to another regulator, shows immediately, and it deprives the reviewer of the map that the rest of the submission assumes.

2. Legal basis

3. Expert insights

1. Elements 4 and 5 are the most underrated part of the executive summary and the most useful one for Cambodia. Cambodia usually refers to the classification and review outcomes of other ASEAN jurisdictions and will accept documentation from reference markets (FDA, EMA, TGA and similar agencies) as a primary clinical evidence source. Setting out the list of approvals obtained and the status of pending applications amounts to proactively supplying the reason ‘why a simplified review in Cambodia is justified’.

1. Disclosing novel features in the ‘Overview’ is a risk-disclosure obligation. The CSDT requires the overview to include any novel features. If the product uses a new material, a new mechanism of action or a new software algorithm, this must be stated explicitly in the executive summary. Concealing a novel feature that later surfaces in another module significantly raises the probability of deficiency requests and reclassification.

1. ‘Significant safety or performance-related information’ must echo Module F (risk analysis). Safety information disclosed in the executive summary should have corresponding entries and mitigations in the risk management report. A mismatch between the two is treated as incomplete risk management.

1. Element 2 (commercial marketing history) and element 4 (approvals obtained) are related but not interchangeable. The marketing history describes where and how long the product has been sold; the approvals list states the formal authorisations with their identifiers. A product can have a long marketing history in markets that require no registration, which supports familiarity but not the reference-market evidence that elements 4 and 5 provide. Presenting both separately, each under its own sub-heading, keeps the two lines of argument distinct and lets reviewers weigh each on its own terms.

1. The discipline of keeping the executive summary current deserves attention in multi-market portfolios. When a product is registered in several countries, Module A is often written once and reused; approvals obtained after the first drafting, or a pending application that has since been decided, then leave the summary describing an earlier state of the world. Because element 4 and element 5 are the direct basis for judging reference-market evidence, a stale approvals list weakens precisely the part of the summary that carries the most weight in the Cambodian review. Refreshing these two elements at the moment of submission, rather than relying on the version written for the first market, is a small cost with a disproportionate effect.

4. Practical recommendations

1. Turn the list of approvals obtained into a table: country/region, approval number, approval date, approved scope. The scope column must state the approved models and intended use so Cambodian reviewers can compare them against the current submission.
2. In the marketing history, state the country and date of first market placement, cumulative sales volume or number of batches, and any recalls or major complaints. Products with a recall history should proactively describe the outcome of the corrective action rather than leave reviewers to discover it.
3. Keep the executive summary within a readable length without dropping any of the six elements. Use numbered sub-headings in CSDT order so reviewers do not have to hunt for the elements in long paragraphs; a summary that reads well in one sitting also reduces the chance that the intended use is misread, which is the single detail most other modules depend on.

5. Verification checklist

• □ Overview covers the device description, intended use, novel features and dossier summary
• □ Commercial marketing history stated (country and date of first market placement)
• □ Intended use and indications as stated in the labelling given
• □ List of regulatory approvals or marketing authorisations provided (country, number, date, scope)
• □ Status of pending applications explained
• □ Significant safety or performance information disclosed and aligned with the Module F risk analysis

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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