罚则与执法：1996 年法第 10 至 13 条的适用

I. Key takeaways

The legal basis for penalties on unregistered or non-compliant devices in Cambodia lies in Articles 10 to 13 of the 1996 Law on the Management of Pharmaceuticals (Prakas No. 1258, being a ministerial regulation, has no power to create penalties):

GRZAN note: the Article 10 fine range is KHR 1,000,000 to 10,000,000 with suspension of business for 1 to 3 months, doubled on repeat; Article 12 reaches up to KHR 50,000,000 or imprisonment of 10 years; the confiscation scope expressly includes “equipment“.

II. Legal basis

III. Expert commentary

1. The confiscation scope expressly includes “equipment” — the most direct risk point for device companies. The final paragraph of Article 10 lists the confiscable items as “pharmaceuticals, raw materials, equipment and other related materials”. For a device company, what is confiscated is not a drug but the device itself, and the value per consignment is usually far higher than for pharmaceuticals, materially amplifying the actual loss.

1. “Immediate provisional suspension” is an exceptionally fast administrative power. The Ministry of Health may suspend unlawful advertising, manufacturing, import-export and operations on the spot, before compiling the case file for referral to the courts. This means that when goods are seized at the port, the company’s operations can be halted the same day — there is no buffer period.

1. The industry-circulated “up to KHR 10,000,000 plus up to 1 year imprisonment” does not match the statute. Article 10 carries no imprisonment, only fines and suspension of business; Article 11’s imprisonment is 6 days to 1 month; Article 12’s is 5 to 10 years. Blending the three into “10,000,000 plus 1 year” finds no corresponding combination in the statute and should not be cited.

IV. Practical recommendations

1. Make “certificate first, despatch second” an inviolable red line. Given that the confiscation scope includes equipment and operations can be suspended on the spot, any “proceed while filing” arrangement carries extreme risk.
2. No advertising material goes live before the licence is obtained. Article 10, item 1 lists advertising without authorisation as the first offence category, and the Ministry of Health can suspend it on the spot.
3. Treat counterfeit and deteriorated product situations as criminal risk. Article 12 carries 5 to 10 years, the heaviest penalty in Cambodia’s pharmaceutical law; if counterfeit or expired product appears in the supply chain, initiate quarantine and reporting immediately rather than handling it internally.

V. Verification checklist

• □ Confirmed that the penalty basis is Articles 10 to 13 of the 1996 law, not a Prakas
• □ Understood that the confiscation scope includes “equipment”
• □ Understood that the Ministry of Health’s “immediate provisional suspension” power carries no buffer period
• □ The “KHR 10,000,000 plus 1 year imprisonment” claim, which does not match the statute, is not cited
• □ “Certificate first, despatch second” red line in place
• □ Noted that Articles 10, 12 and 13, as amended in 2007, are governed by the current text

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).

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