广告许可：事前审批、内容边界与跨部门执法

I. Key takeaways

In Cambodia, advertising, communication and promotional activities for medical devices all require a DDF advertising licence obtained in advance. The requirement applies to all media formats and promotional forms. There is also a substantive content boundary: advertising content must match the product’s registered details and must not contain misleading, exaggerated or scientifically unsupported claims.

The consequence is not merely that the advertisement is stopped: under Article 10, item 1 of the 1996 Law on the Management of Pharmaceuticals, pharmaceutical advertising without Ministry of Health authorisation is one of the punishable offences; enforcement authorities can include both the Ministry of Health and the Ministry of Commerce.

GRZAN note: advertising compliance carries 2 constraints — prior licensing and content staying within the registered scope; the penalty basis is Article 10, item 1 of the 1996 law; enforcement sits with the Ministry of Health and the Ministry of Commerce (2 authorities).

II. Legal basis

III. Expert commentary

1. The advertising licence is a stand-alone obligation (article 36 in this series) that does not exist in most device markets. Most markets regulate device advertising after the fact or through industry self-regulation; Cambodia makes it a prior licence. Companies that follow the promotional rhythm of other markets will hit a gap where the product has arrived and the materials are printed, but the advertising has not been approved.

1. “Content must match the registered details” is a substantive review standard, not a formality. Indications, performance claims and intended patient populations in the advertising must all fall within what the registration certificate and the instructions for use state. Globally produced corporate materials often include indications not registered locally; deploying them as-is is a violation.

1. The control agents’ monitoring scope covers “any other media”. The Cambodian Prakas on control agents’ duties expressly empowers them to monitor whether commercial marketing on television, radio, newspapers, magazines, medical and dental journals, and by any other means, complies with the Ministry of Health licence. This catch-all wording brings social media, e-commerce pages, conference booths and other new channels within the regulatory field of view.

IV. Practical recommendations

1. Move the advertising licence application to before the product arrives. Start the licence application for the first batch of materials at the same time as the registration submission, running in parallel with the review.
2. Produce a Cambodia-specific version of the materials. Cap the content at what the registration certificate and the instructions for use state, and delete indications and comparative claims from corporate materials that are not registered locally.
3. Keep a materials register. Record, for each version, the media it covers, the approval number and the validity period; re-check whether materials remain valid whenever the local representative changes or the registration certificate is varied.

V. Verification checklist

• □ Confirmed that advertising, communication and promotion all require a DDF advertising licence obtained in advance
• □ Licence application for the first batch of materials started in parallel with the registration application
• □ Advertising content checked against the scope of the registration certificate and the instructions for use
• □ Indications and comparative claims not registered locally deleted from corporate materials
• □ Materials register in place (media, approval number, validity period)
• □ Social media and e-commerce pages covered by materials management

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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