费用与预算：官方可读文本里没有的那些数字

I. Key takeaways

The official government fee for device registration in Cambodia cannot be located in officially readable texts. The figure widely circulated in the industry is KHR 400,000 (approx. USD 100), but its origin is believed to be a joint Prakas on the pharmaceutical side, governing drugs rather than devices.

GRZAN’s handling principle: any figure that cannot be located in officially readable texts is never stated as a confirmed value. Budget on the basis of the DDF’s current payment notice, and note these structural facts:

• Payment occurs after the DDF completes its assessment and before the committee’s deliberation;
• The fee is a government fee and excludes third-party costs such as local representative service fees, translation, notarisation and consular legalisation fees, sample testing fees, and travel and warehousing;
• Because there is no product grouping, fees accumulate per model, not once per product family.

GRZAN note: the circulating government fee is 400,000 riel (approx. 100 US dollars), but its traceability to a source is doubtful; budget should accumulate by SKU count; the payment point falls within the 1 window between completion of assessment and committee deliberation.

II. Legal basis

III. Expert commentary

1. “Not in the official texts” is itself a fact that must be explained to clients. In many markets the registration fee can be found in a legislative annex; in Cambodia it cannot. Explaining this clearly is more valuable than quoting a possibly wrong number — it avoids later disputes about inaccurate budgets.

1. The real cost drivers are usually not the government fee. For most projects the larger cost components are: local representative service fees, translation, notarisation and consular legalisation fees (article 29), dossier preparation costs accumulated per SKU, sample testing fees, and the time cost of missing a committee window. Even at USD 100, the government fee is often the smallest line in total cost.

1. “Accumulation per model” is systematically underestimated. With no product grouping, the government fee for 20 SKUs is 20 times higher, and dossier preparation costs approach 20 times as well. A Cambodia budget for a multi-SKU product modelled as “one registration” will be off by an order of magnitude.

IV. Practical recommendations

1. Build the budget in two blocks: “Government fees (pending DDF notice)” and “Third-party costs (estimable)”. Leave the former blank or mark a range; estimate the latter item by item per SKU count.
2. Count “missing a committee window” as opportunity cost. A single 3 to 4 month slip — the associated capital tied up and lost market window — often exceeds all direct costs.
3. Confirm the current fee in writing. Have the local entity obtain written confirmation from the DDF of the current payment basis (email or reply letter) and archive it, rather than relying on verbal answers.

V. Verification checklist

• □ Budget separates “government fees (pending notice)” from “third-party costs (estimable)”
• □ Government fee not stated as a confirmed value; noted as subject to the DDF’s current notice
• □ Third-party costs estimated by accumulating per SKU count
• □ Translation, notarisation and consular legalisation fees itemised and included in the critical path
• □ Written confirmation process for the current payment basis under way
• □ Opportunity cost of missing a committee window included in the project’s economic assessment

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, while Cambodia still has no dedicated Medical Device Law; the current rules are pieced together from three layers — the registration-number legal basis provided by the 1996 Law on the Management of Pharmaceuticals and its 2007 Amendment Law, the classification and procedures provided by Prakas No. 1258 of 2012, and the technical framework provided by the ASEAN Medical Device Directive (AMDD) — so compliance certainty is markedly lower than in markets that have completed legislation. Second, local authorised representative services: GRZAN acts as the manufacturer’s statutory representative in Cambodia, handling registration submissions, regulatory communication and post-market reporting obligations, and helping resolve the practical issues of the Cambodian registered pharmacist and the Import-Export Pharmaceutical Company Licence. Third, quality system and testing support: establishing a quality management system conforming to ISO 13485 and organising the technical dossier under the ASEAN Common Submission Dossier Template (CSDT).

Business enquiries: info@grzanglobal.com