东盟 CSDT 七大模块逐项拆解（AMDD 附件 4）

1. Key takeaways

The technical dossier for Cambodia is organised under the ASEAN Common Submission Dossier Template (CSDT), the Annex 4 referred to by Article 8(a) of the AMDD. The CSDT has 7 modules:

GRZAN note: the CSDT has 7 modules; the legal basis is Article 8(a) of the AMDD and Annex 4; the accompanying completion guidance was published on 21 October 2010 and runs to 31 pages.

2. Legal basis

3. Expert insights

1. Organising the dossier under the CSDT is the highest-return single decision in a Cambodian project. There are two reasons. First, the provisions of Prakas No. 1258 are not fully public and the device-side online guidance is still “coming soon”, so the CSDT is the only stable, item-by-item searchable basis available. Second, at the first ASEAN Medical Device Roundtable on 9 September 2026, participants agreed in principle to advance a single submission model; technical dossiers may in future be collected and distributed through one harmonised entry point — a dossier built to the CSDT can be reused directly, with no rework.

1. Module B is the “logic of evidence” and Module D the “depth of evidence”; do not conflate the two. Module B answers “which essential principles apply and by what method conformity is demonstrated”; Module D answers “how deep verification and validation must go”. The common practical error is piling test reports into Module D while writing the Module B checklist in broad terms, leaving the reviewer unable to establish the requirement–method–evidence chain.

1. The Module F risk analysis is explicitly recommended to follow ISO 14971. The CSDT text states that risk management activities should be carried out in accordance with ISO 14971 and a risk management report provided, containing detailed information on the risk analysis, risk evaluation and risk control for the medical device. This is one of the rare named standards in the CSDT, showing that risk analysis carries independent weight in Cambodian review.

4. Practical recommendations

1. Build the dossier index in A→G order and keep it consistent with the Thai, Malaysian, Singaporean and Indonesian versions. Maintain one master dossier, with each ASEAN country version localised on its basis, rather than starting afresh for each country.
2. Put the module letter into the file names. For example CSDT_A_Executive-Summary_<model>.pdf, so reviewers can navigate directly and the company can locate the module when making later changes.
3. Make the Module B checklist three columns: essential principle / applicable or not / document reference for conformity evidence. With all three columns complete, the DoC and the checklist corroborate each other and form a complete evidence chain.

5. Verification checklist

• □ Technical dossier organised across CSDT Modules A to G
• □ Module A contains all 6 elements (including pending approvals and significant safety information)
• □ Module B checklist in three columns: requirement / applicability / evidence reference
• □ Module D verification and validation depth adjusted per Class B/C/D
• □ Module F risk management report provided in accordance with ISO 14971
• □ Dossier index and file names include module letters for change traceability

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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