混合递交：纸质行政卷 + U 盘技术卷 + 线上填报

1. Key takeaways

Cambodia’s current device submission format is a hybrid model; all three channels must be satisfied simultaneously:

The reason for this format: CamPORS was designed to be fully paperless, but the online application guidance for devices has not yet gone live — as of 15 October 2026 the device application guidance page on the DDF website still displayed “Medical Device Application coming soon”, while the pharmaceutical side of the same website already carried a 190-page registration guide published on 1 August 2019.

GRZAN note: hybrid submission involves 3 parallel channels; the official pharmaceutical-side guide is 190 pages (1 August 2019), while the device-side guidance page still read “coming soon” as of 15 October 2026.

2. Legal basis

3. Expert insights

1. The coexistence of a “paperless goal” and a “paper original requirement” is the classic signature of a transition period. CamPORS was built with WHO support and positioned as fully digital; but until the online functions of the device module are finished, administrative documents still need hard copies. Preparing only for online submission leads to rejection for missing paper originals; preparing only on paper leads to rejection for missing online entry.

1. A USB drive instead of the cloud for the technical dossier imposes concrete preparation requirements. Section 2.2.3 of the pharmaceutical-side guide provides standards that can be applied directly: technical files should be searchable PDFs (not scanned images, unless processed by OCR), not encrypted, and where larger than 50 MB should come with a cloud link and an access password; fonts not supported by Word should not be used; and the files must be bookmarked so reviewers can jump directly to sections. Although these requirements sit in the pharmaceutical-side guide, they apply equally to the device technical dossier.

1. An absence of device guidance is not an absence of requirements. Seeing only a single line of “coming soon” on the device page, applicants may conclude that Cambodia has no written requirements for devices. The opposite is true — devices must be registered; only the online guidance has not been completed. In this situation, the CSDT under AMDD Annex 4 is the only publicly available, stable, item-by-item searchable set of technical requirements and should serve as the default basis for compiling the technical dossier.

4. Practical recommendations

1. Build a “three-channel checklist”. Turn the online data-entry items, the paper originals list and the USB file directory into a single cross-reference table and tick each item before submission. Missing any one of the three means the pre-review fails.
2. Prepare technical dossier PDFs to the pharmaceutical-side standards. Searchable, unencrypted, bookmarked, with a cloud link for anything over 50 MB. This is a low-cost but high-frequency rejection point.
3. Data on the USB drive and in the online entry must match field by field. The risk of hybrid submission is the same information diverging across two carriers (model naming, manufacturer address, validity date format, for example). Generate both outputs from one master data set rather than re-keying manually.

5. Verification checklist

• □ CamPORS online data entry completed
• □ Paper administrative dossier (application form, LoA, DoC, ISO/GMP, company documents, labelling) assembled
• □ Technical dossier compiled to CSDT and stored on the USB drive
• □ Technical dossier PDFs searchable, unencrypted, bookmarked
• □ Files over 50 MB accompanied by cloud link and access password
• □ Data across online entry, USB drive and paper documents reconciled field by field

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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