第 1258 号 Prakas 在柬埔寨法规体系中的位阶

1. Key Takeaway

Prakas No. 1258 on Procedures for Registration of Medical Devices (Prakas No. 1258), issued on 8 November 2012, is the only domestic implementing instrument in Cambodia aimed directly at medical devices. Within Cambodia’s legal hierarchy, a Prakas is a ministerial regulation ranking below statute (instruments promulgated by Royal Kram); its validity derives from empowerment by a superior law — Article 7 of the 1996 Law on the Management of Pharmaceuticals expressly empowers the Ministry of Health to determine by Prakas the conditions for opening pharmacies, the registration and visa procedures, the technical conditions for the management and storage of pharmaceuticals, advertising conditions, and the procedures for manufacturing and import-export trading.

The validity of the number is officially corroborated: Prakas No. 1258 appears in the official slides presented by the DDF at the 2024 ASEAN Medical Device Committee (AMDC) public forum, and the conference materials were compiled by APACMed.

GRZAN note: Prakas No. 1258 was issued on 8 November 2012 and is the 1 domestic instrument aimed directly at devices in Cambodia; its empowering source is Article 7 of the 1996 Law; the A/B/C/D classification, 4 classes in total, is brought to the domestic implementation level by this Prakas.

2. Regulatory Basis

3. Expert Commentary

1. The hierarchy determines what it can and cannot do. A Prakas may set procedures, classification, document checklists and format requirements, but cannot create penalties. Prakas No. 1258 and the AMDD together therefore constitute the technical requirements, while penalties must be traced back to Articles 10 to 13 of the 1996 Law. Understanding this lets a company judge whether a given requirement is a “technical threshold” or a “legal liability”, and choose its response accordingly.

1. There is a time gap between the 2012 instrument and the AMDD of 2015. Prakas No. 1258 was issued in 2012, before the AMDD entered into force in 2015. Its classification system was therefore aligned with the AMDD through later harmonisation, not by original design. This also explains why the procedural figures on the device side in Cambodia — fees, timelines and validity periods — are hard to locate in officially readable text: a 2012 procedural instrument does not necessarily cover them, and later supplementary rules have not been fully published.

1. The authorities confirm the number but the full text has not been published; this is a Cambodia-specific risk. The number of Prakas No. 1258 can be confirmed in official DDF slides, but a publicly readable version of its provisions has not been obtained. This contrasts with markets such as Thailand, Malaysia and Vietnam that have established written device regulatory systems, where rules can be searched article by article in official repositories; Cambodia instead relies heavily on the current interpretation of the competent authority.

4. Practical Recommendations

1. Do not rely on third-party paraphrases of “the text of Prakas 1258”. Several “provision details” circulating in the market cannot be traced to any official original. For judgments on specific obligations, obtain written confirmation from the DDF through the local licensed entity.
2. Use the AMDD as the stable anchor for technical requirements. Because the domestic provisions are not adequately public, preparing the technical documentation to AMDD Annex 4 (CSDT) and Annexes 2/3 (classification rules) is the only approach that satisfies both “compliance” and “reusability”.
3. Set up monitoring for Prakas updates. On 17 November 2025 the DDF issued a batch of Prakas in a single release, covering pharmaceutical registration procedures, medical device registration, cosmetic application requirements, advertising, and the management of medical device manufacturers. The numbers and texts of these instruments have not been obtained, but their existence shows that the rules of the Prakas 1258 era are being revised; confirm the currently applicable version before submitting.

5. Verification Checklist

• □ Number and date of Prakas No. 1258 confirmed (8 November 2012)
• □ Understood that a Prakas is a ministerial regulation ranking below statute
• □ Located its empowering source in Article 7 of the 1996 Law
• □ Confirmed penalties do not come from the Prakas and must be traced to Articles 10 to 13 of the 1996 Law
• □ Monitoring mechanism for Prakas updates on the DDF website in place (including the 17 November 2025 batch)
• □ Technical documentation organised to AMDD Annex 4 CSDT, without reliance on unpublished provisions

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).

Business enquiries: info@grzanglobal.com