市场检查与假冒产品查处：跨部门委员会的运作方式

1. Key takeaway

Market surveillance in Cambodia is carried out by Ministry of Health control agents (inspectors), supported by an Inter-Ministerial Committee for the Suppression of Counterfeit Medicines and Illegal Medical Services. The inspectors’ mandate covers manufacturers of pharmaceuticals, traditional medicines, psychotropic and narcotic substances, medical devices, reagents and cosmetics, as well as import and export enterprises, pharmacies, warehouses, cosmetics shops and beauty centres.

The inspectors’ specific powers include:

• At least one inspection of each manufacturer per year (using an evaluation checklist); urgent inspections require Ministry of Health authorisation;
• Inspections of import and export enterprises, pharmacies, warehouses and similar premises against the evaluation checklist; provincial inspectors inspect such premises at least once per quarter;
• Monitoring the circulation of pharmaceuticals and medical products on the market; for suspect products they may suspend sale and distribution and take samples for testing;
• Supervising commercial marketing on television, radio, newspapers, magazines, medical and dental journals and any other media for consistency with Ministry of Health authorisation;
• Provisionally seizing counterfeit medicines, medicines banned by the Ministry of Health, unlicensed medicines, expired medical devices, reagents, cosmetics, raw materials and excipients.

GRZAN note: manufacturers are inspected at least once per year; provincial inspection of pharmacies and similar premises takes place at least once per quarter; the provisional seizure scope explicitly includes expired medical devices and reagents.

2. Regulatory basis

3. Expert commentary

1. “Expired medical devices and reagents” are explicitly within the provisional seizure scope — a high-frequency risk for device companies in Cambodia. Pharmaceuticals have well-established shelf-life management practice; expiry management for devices (especially equipment and consumables) is often neglected. Inspectors may seize expired devices and reagents directly and refer the matter to the Inter-Ministerial Committee for decision.

1. Advertising oversight is one of the inspectors’ routine duties, not a special campaign. During routine inspections, inspectors will also check whether the company holds an advertising authorisation and whether the advertising content matches it. This means that advertising compliance (see article 36) is not a ”file once and done” exercise but a continuing obligation that will be checked repeatedly.

1. “At least once a year” versus ”at least once a quarter” is an asymmetrical frequency design. Manufacturers are inspected less often than the distribution side. This matches Cambodia’s position as a purely import-driven market — regulatory resources are concentrated on the distribution chain. Importers and distributors therefore face a higher probability of inspection than local manufacturers.

4. Practical recommendations

1. Establish a shelf-life inspection routine focused on devices and reagents. In Cambodia’s hot and humid climate, expiry and storage-condition management should be held to a higher standard than in other markets.
2. Keep advertising authorisation documents and a materials ledger ready for inspection at any time. Inspectors may verify advertising compliance as part of a routine inspection.
3. Prepare to a higher standard for inspections on the distribution side. Importers and distributors are inspected more frequently; have registration certificates, import licences, import/export records, complaint records and proof of the pharmacist’s presence ready in advance.

5. Verification checklist

• □ Awareness that manufacturers are inspected at least once a year and the distribution side at least once a quarter at provincial level
• □ A shelf-life inspection routine for devices and reagents has been established
• □ Advertising authorisation documents and the materials ledger are ready for inspection at any time
• □ Registration certificates, import licences, import/export records and complaint records are prepared on the distribution side
• □ Proof of the pharmacist’s presence can be provided at any time
• □ Awareness that the provisional seizure scope includes expired medical devices and reagents

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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