Certificate of Analysis (CoA) and Samples or Catalogue

1. Key takeaways

Prakas No. 1258 differentiates the evidence route for this item by class:

The annex list of the administrative section carries a separate item, the Certificate of Analysis from the country of origin, which answers to the analysis report in the technical section for Classes B/C/D. The difference between the two: the annex item is a certificate issued in the country of origin, while the technical-section item is a batch analysis report issued by the manufacturing organisation.

The distinction answers to two different review questions. The origin-country certificate tells the reviewer that the product, as manufactured in and exported from its home market, is subject to analysis there under that market’s controls; the manufacturing-organisation report tells the reviewer what the specific production organisation tests, batch by batch, and with what results. Neither substitutes for the other: the first speaks about the product’s regulatory provenance, the second about its production reality. Preparing one document and submitting it twice under both names is a recognisable shortcut and does not satisfy either question.

GRZAN note: the evidence route for this item has 2 tiers — Class A substitutes samples or a catalogue, while Classes B/C/D must add the CoA; the administrative annex list has 9 items in total, 1 of which is the Certificate of Analysis from the country of origin.

2. Legal basis

3. Expert insights

1. The Class A option of ‘substituting samples or a catalogue for full technical documentation’ is one of Cambodia’s few burden-reducing designs. It reduces only the technical documentation, not the administrative papers — Class A still requires GMP/ISO certificates, a Certificate of Free Sale and the letter of authorisation. Companies that read ‘Class A is simple’ as ‘the whole dossier is simple’ will stumble on the administrative section.

1. Batch representativeness of the CoA is the key. The analysis report issued by the manufacturing organisation should correspond to a representative batch or the batch under submission, and the tests should cover the critical performance items in the product technical requirements. A generic CoA template without batch-specific data is usually not treated as valid evidence in review.

1. Sample submission involves two practical issues: import and retention. Cambodia requires sample products to be submitted, and samples entering Cambodia go through import procedures as well. The local entity should confirm the import handling of the samples in advance and allow for the possibility that the DDF retains the samples without returning them.

1. The catalogue route for Class A also has a documentation-quality dimension. Because the catalogue substitutes for technical documentation, its content is read with more attention than a marketing catalogue normally receives: model designations must match the application form exactly, and any specification stated in it becomes part of the submitted record. An out-of-date catalogue submitted for convenience can therefore introduce inconsistencies that outweigh the convenience. Maintaining a submission-specific catalogue extract, rather than sending the full commercial catalogue, keeps the record aligned with the application.

1. Sample logistics deserve a place on the project plan rather than a footnote. Samples that arrive after the dossier has been checked against the list arrive as a deficiency, whatever their quality; samples held up in import handling delay the whole submission through no fault of the documents. Confirming the import route, the receiving arrangements and the possibility of retention before the dossier is lodged converts two uncertainties into settled logistics — the kind of settlement reviewers implicitly assume when they open a submission.

4. Practical recommendations

1. Manage the CoA for Classes B/C/D together with the certificate validity matrix in article 15 of this series. A CoA usually relates to a specific batch; once dossier review spans 12 to 18 months, an early CoA may be treated as ‘stale’, so prepare updates on a rolling 12-month basis.
2. When Class A submits a catalogue, the catalogue must prove the product identity on its own. It should state models, specifications, intended use and manufacturer details, matching the product information on the application form item by item.
3. Submit samples and the catalogue together with the dossier, not later as a supplement. The pre-review checks against the list and returns anything missing.

5. Verification checklist

• □ Evidence route confirmed by class (Class A samples/catalogue; Classes B/C/D add the CoA)
• □ CoA for Classes B/C/D issued by the manufacturing organisation and tied to a specific batch
• □ CoA test items cover the critical performance of the product
• □ Certificate of Analysis from the country of origin ready in the administrative annex
• □ Class A catalogue states models, specifications, intended use and manufacturer details
• □ Import handling and retention of samples confirmed with the local entity

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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