主管机关是谁：柬埔寨卫生部 DDF 的权限边界与在线门户

1. Key Takeaway

The competent authority for medical devices in Cambodia is the Department of Drugs and Food (DDF) under the Ministry of Health (MoH). The department’s full Khmer title already includes the words “medical devices”, and its English name is conventionally rendered as the Department of Drugs and Food. DDF performs four functions — registration intake, technical review, import control and post-market surveillance — making it a single-window competent authority.

The online submission portal is the Cambodia Pharmaceutical Online Registration System (CamPORS), launched on 1 August 2019 by the Ministry of Health with World Health Organization support. The officially listed registrable categories total 7, and medical devices are expressly among them: therapeutic pharmaceuticals, cosmetics, health foods, health supplements, medical devices, traditional medicines, and brand and labelling approvals.

GRZAN note: DDF is a single-window competent authority with 4 functions concentrated in one department; CamPORS went live on 1 August 2019 and covers 7 registrable categories; the official contact channels are the email address info.campors@moh.gov.kh and the telephone number (855)23-885-970.

2. Regulatory Basis

3. Expert Commentary

1. “Single window” means there is no internal checks-and-balances buffer. In markets with separated functions, an appeal or review channel usually sits between review comments and access decisions; Cambodia’s structure concentrates intake, review, import control and post-market surveillance — all four powers in the DDF. This simplifies the communication path, but it also means a deficiency letter is close to the final word, so submission quality must be right the first time.

1. Although “pharmaceutical” appears in the CamPORS name, devices are genuinely within its scope. The official description lists the registrable categories item by item, and medical devices are a stand-alone item; no inference is needed. The common misjudgement is to see a system named “pharmaceutical online registration system” and conclude it covers drugs only — in fact it is also the submission channel for devices.

1. Account activation is a pre-screen. CamPORS requires a company to register online first and then have its originals verified in person by a DDF official before access is granted. Procedurally this looks like paperwork, but in substance it moves the question of “who is entitled to sit in the applicant’s seat” forward, before document preparation. Until access is granted, any submission plan is only a draft.

4. Practical Recommendations

1. Open the account first, then schedule the documents. Treat CamPORS local company registration and original-document verification as the project’s first milestone, not a parallel task. If the entity’s eligibility is refused after translation and notarisation have already been commissioned, all of that work is wasted.
2. Put the DDF’s contact details into the project contact list. The official email and telephone are the direct channels for confirming the “current position”; for items that cannot be located in official text — fees, timelines, validity periods — get the answer in writing by email or reply letter, not as a verbal statement only.
3. Design the communication strategy around the single window. Because there is no inter-departmental buffer, have the local licensed entity deal with the DDF on a single front; avoid the overseas manufacturer, the local representative and the translation agency writing separately and creating inconsistent positions.

5. Verification Checklist

• □ Confirmed the competent authority is the DDF under the Ministry of Health, with names consistent with the glossary
• □ Completed local company registration on CamPORS and passed DDF verification of originals
• □ Confirmed the registrable categories list includes medical devices
• □ Recorded the DDF official email and telephone, and designated a single point of contact
• □ “Account activation” set as the first milestone in the project plan
• □ Confirmed no inter-departmental appeal buffer exists, and first-submission quality self-checked against final-review standards

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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