器械侧线上指引为何仍是 coming soon：官方信息缺口管理

1. Key takeaway

Public information disclosure by the Cambodian regulator is markedly asymmetric:

• Pharmaceutical side: the DDF website publishes the Guidelines on Registration of Therapeutic Product in Cambodia, issued on 1 August 2019, running to 190 pages, with detailed provisions on PDF preparation, languages and certification of translations;
• Device side: as of 15 October 2026, the medical device application guideline page on the DDF website (ddf.moh.gov.kh/guidelines/medical-device-application) still displays “Medical Device Application coming soon”.

One side is 190 pages; the other is a single line. That difference is not a detail.

GRZAN note: the pharmaceutical guideline runs to 190 pages (1 August 2019); the device guideline page still shows 1 line of ”coming soon” as of 15 October 2026; the device-side online application module remains within the CamPORS framework, but administrative and technical files are still submitted on physical media.

2. Regulatory basis

3. Expert commentary

1. “The guideline page is empty” is most easily misread as ”Cambodia has no requirements for devices”. This is a dangerous inference in reverse. Devices must be registered; only the device-side online guideline has yet to be filled in. Whether a requirement exists should be judged from the legal basis and implementing instruments (the 1996/2007 laws, Prakas No. 1258, the AMDD), not from how full the web page is.

1. The information gap is itself a compliance cost. In a market with opaque rules, companies cannot self-check against public texts and must rely on the experience of the local entity and the DDF’s current interpretation. This raises dependence on the quality of the local partner — choosing the wrong partner costs more in Cambodia than in markets with transparent rules.

1. The pharmaceutical guideline can serve as a reasonable proxy for technical requirements. The PDF preparation requirements of the pharmaceutical guideline (searchable, unencrypted, bookmarked, with a cloud link for files over 50 MB) and the language and translation certification requirements are procedural technical requirements independent of product category. Preparing the device dossier to this standard both satisfies pre-screening and reduces the chance of rejection. This is a workable substitute while the information gap persists.

4. Practical recommendations

1. Use Sections 2.2.3 and 2.3 of the pharmaceutical guideline as the preparation standard for the device dossier. These two sections are procedural requirements and apply across product categories.
2. Do not lower the documentation standard because the device page is empty. Compiling to Annex 4 CSDT of the AMDD is safer than preparing to an imagined ”relaxed requirement”.
3. Archive the local entity’s DDF communication records as a project asset. In a market with opaque information, historical correspondence is an important basis for judging the current interpretation. When changing partners, require the handover of such records.

5. Verification checklist

• □ Status of the device guideline page confirmed (still ”coming soon” as of 15 October 2026)
• □ No inference of ”no registration requirement” drawn from the empty guideline page
• □ Device dossier prepared to the PDF and language requirements of the pharmaceutical guideline
• □ Technical dossier organised to Annex 4 CSDT of the AMDD
• □ The local entity’s DDF communication records listed as a project asset
• □ Regular reviews of whether the device guideline page has been updated

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 Law. The current rules are assembled from three layers: the legal basis for registration numbers provided by the 1996 Law on the Management of Pharmaceuticals and its 2007 amendment, the classification and procedures provided by Prakas No. 1258 of 2012, and the technical framework of the ASEAN Medical Device Directive. Regulatory certainty is therefore markedly lower than in markets that have completed legislation. Second, local authorised representative services: GRZAN may act as the manufacturer’s statutory representative in Cambodia, carrying registration submissions, regulatory communication and post-market reporting obligations, and assisting with the practical implementation of the Cambodian registered pharmacist and pharmaceutical import/export enterprise licence requirements. Third, quality system and testing support: assisting with the establishment of a quality management system meeting ISO 13485 requirements, and organising the technical dossier in accordance with the ASEAN Common Submission Dossier Template (CSDT).

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