立法动态：《医疗器械法》起草进展与企业应对

1. Key takeaway

Cambodia has no dedicated Medical Device Law, and such a law is still at the drafting stage. The authoritative basis for this assessment is the World Health Organization and UN Global Marketplace (UNGM) legal services tender notice No. 256053 (published on 20 December 2024), which states that the Department of Drugs and Food (DDF) of the Cambodian Ministry of Health has initiated procedures to develop and update legislation on medical products, with drafting projects covering three laws: a Law on Pharmaceuticals, a Medical Device Law and a Cosmetics Law.

Another date worth noting: from 19 to 22 August 2025, the 14th meeting of the ASEAN Medical Device Committee (AMDC) was held in Siem Reap, Cambodia (conference banner on the DDF website homepage). Hosting a regional meeting is usually accompanied by domestic legislative and procedural housekeeping.

GRZAN note: the legislative status is 0 laws enacted and 1 law in drafting; the key evidentiary date is 20 December 2024 (UNGM notice 256053); the regional milestone is 19 to 22 August 2025 (Siem Reap).

2. Regulatory basis

3. Expert commentary

1. In a market whose legislation is still being drafted, rule stability is lowest but the value of the window is highest. Cambodia’s current rules are a three-layer assembly of the 1996 law, the 2012 Prakas and the 2015 AMDD; limited publication of the texts means low regulatory certainty for companies. Looked at the other way, legislation in progress means the regulator’s need for compliant companies is rising — compliant companies that enter early often gain de facto influence over the legislative process.

1. The legislative direction can be anticipated, but do not present it as settled fact in your documents. The wording of the UNGM notice (drafting alongside the Law on Pharmaceuticals and the Cosmetics Law) indicates that Cambodia is moving medical product regulation from ”one old law governing everything” towards product-category-specific legislation. The trend may be stated; specific provisions may not — until provisions are enacted, any statement that ”the new law requires X” is fabrication.

1. The batch of Prakas issued by the DDF on 17 November 2025 is a nearer-term change than the legislation. These documents cover pharmaceutical registration procedures, medical device registration, cosmetics application requirements, advertising, and management of medical device manufacturers. Although the numbering and texts have not been obtained, they show that the rules of the Prakas No. 1258 era are being revised; companies should add ”confirm the currently applicable version” to their pre-submission checklists.

4. Practical recommendations

1. Set up three-tier monitoring: UNGM tender notices, the legal documents page of the DDF website, and AMDC meeting outcomes. Review once per quarter to catch legislative and rule changes.
2. Add an ”applicable version confirmation” step before submission. Confirm with the local entity which version of the Prakas currently applies, in particular whether the November 2025 batch has entered into force and replaced the old rules.
3. Prepare against the existing rules, and leave interfaces for the future rules. Organise the technical dossier to CSDT (very likely to be retained after legislation) and structure the entity around the current local licensing requirements (very likely to be retained after legislation); neither needs to wait.

5. Verification checklist

• □ Confirmed that Cambodia has no dedicated Medical Device Law and that drafting is under way
• □ UNGM notice 256053 (20 December 2024) recorded as evidence
• □ UNGM, the DDF website and AMDC meetings included in quarterly monitoring
• □ An ”applicable version confirmation” step added before submission
• □ The current validity of the 17 November 2025 Prakas batch confirmed
• □ Technical dossier organised to CSDT, capable of continuing after legislation

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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