柬埔寨没有专门的《医疗器械法》：现行注册依据到底是哪几份文件

1. Key Takeaway

Cambodia has not enacted a dedicated Medical Device Law. Companies planning to enter the Cambodian market cannot follow the usual route of “find the device law and work through it article by article”; they must instead return to the question of exactly which documents the current rules are assembled from. GRZAN’s research confirms that Cambodian medical device rules form a three-layer assembled structure:

• Statutory layer: the Law on the Management of Pharmaceuticals, promulgated by Royal Kram (royal decree) on 17 June 1996, provides the legal source of the “registration number required by the Ministry of Health” and the penalties;
• Ministerial layer: Prakas No. 1258 of 8 November 2012 on Procedures for Registration of Medical Devices provides the A/B/C/D four-class classification and the registration procedures, and is currently the only domestic implementing instrument aimed directly at devices;
• Regional layer: the ASEAN Medical Device Directive (AMDD), which entered into force on 1 January 2015 under its Article 22, provides the technical framework of the device definition, the classification rules, the common technical document template and the post-market alert system.

The absence of a dedicated law has independent corroboration: procurement notice No. 256053 for legal services (published on 20 December 2024) issued by the World Health Organization and the United Nations Global Marketplace (UNGM) records that the Department of Drugs and Food (DDF) of Cambodia’s Ministry of Health has started the process of developing and updating legislation on medical products, one item of which is drafting a Medical Device Law alongside a Pharmaceutical Law and a Cosmetics Law. Since the law is still at the drafting stage, it has not been enacted.

GRZAN note: the Cambodian device rules can be summarised as 3 assembled layers — 1 foundational law of 1996, 1 Prakas No. 1258 of 2012 and 1 AMDD in force since 2015 — while the count of dedicated Medical Device Laws to date is 0.

2. Regulatory Basis

3. Expert Commentary

1. “No dedicated law” and “no requirements” are two different things. Although Cambodia has no dedicated device law, the three-layer assembly still forms a complete chain of obligations: the 1996 Law provides the legal source of the registration number and the penalties, Prakas No. 1258 provides the classification and the procedures, and the AMDD provides the technical documentation and the post-market technical frame of reference. Concluding that Cambodia has no market access threshold because “no device law can be found” is the most common misjudgement in this market.

1. The legal hierarchy means the penalties must be traced back to the 1996 Law. A Prakas (ministerial regulation) ranks below statute and cannot create criminal or administrative penalties on its own. Penalties for unregistered devices in Cambodia are therefore actually imposed under Article 10 of the Law on the Management of Pharmaceuticals (manufacture, import, export or storage of pharmaceuticals without Ministry of Health authorisation). Only with this layer understood can one explain why device companies are penalised under pharmaceutical provisions.

1. The AMDD text itself is not a provision of Cambodian domestic law. The AMDD is a regional harmonisation instrument at ASEAN level, and its Article 22 states expressly that the Directive is valid only among member states that have ratified or accepted it. When citing the AMDD, the accurate formulation is “the regional harmonisation obligations Cambodia has undertaken as a party to the AMDD”, not “Cambodian law provides”. This distinction is especially critical when issuing compliance opinions.

4. Practical Recommendations

1. Change the search keywords. Stop using “Cambodia medical device law” as the entry point; run three parallel tracks instead: the Law on the Management of Pharmaceuticals and its amendment, Prakas No. 1258, and the relevant AMDD articles and ASEAN guidance. Track the legal documents page of the DDF website and UNGM procurement notices at the same time to catch legislative progress.
2. Write “to be verified” into project documents. Device-side fees, review timelines and certificate validity periods in Cambodia cannot be located in any officially readable text. For external commitments involving budget and scheduling, rely solely on the DDF’s current written confirmation; do not cite figures from third-party websites.
3. Prepare documentation on the basis of “law that exists”, not “law that is coming”. Even if a Medical Device Law is enacted in the future, the skeleton of the technical dossier will remain the ASEAN CSDT. Materials prepared under the current three-layer structure will not become obsolete; waiting for legislation only loses market window.

5. Verification Checklist

• □ Confirmed that Cambodia has no dedicated Medical Device Law and that none is in “enacted but not yet in force” status
• □ Obtained the 1996 Royal Kram text of the Law on the Management of Pharmaceuticals and the text of the 2007 amendment
• □ Confirmed that the current operating basis is Prakas No. 1258 (8 November 2012)
• □ Confirmed that Cambodia is a party to the AMDD and understood the entry-into-force limitation in AMDD Article 22
• □ All fees, timelines and validity periods in project documents marked “practical estimate” or “to be verified”
• □ Legislative tracking mechanism for the DDF website and UNGM notices in place

Regulatory information verified as of 29 October 2026.

In Southeast Asia, GRZAN’s core capabilities concentrate on three areas. First, distinguishing the legislative progress of dedicated medical device laws across member states — Singapore, Malaysia, Thailand, Indonesia, the Philippines and Vietnam have each established a written device regulatory framework, whereas Cambodia still has no dedicated Medical Device Law; its current rules are assembled from three layers — the registration-number legal basis 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 provided by the ASEAN Medical Device Directive — leaving regulatory certainty materially 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 submissions, regulatory communication and post-market reporting obligations, and assisting with the practical implementation of the Cambodian registered pharmacist requirement and the pharmaceutical import and export enterprise licence. Third, quality system and testing support: helping establish a quality management system meeting ISO 13485 requirements and organising the technical dossier according to the ASEAN Common Submission Dossier Template (CSDT).

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