CamPORS 门户账号开通：本地公司注册与原件核验

1. Key takeaways

The Cambodian Online Pharmaceutical Registration System (CamPORS) went live on 1 August 2019, launched by the Cambodian Ministry of Health with World Health Organization support, with the goal of a fully paperless process. The officially listed registrable categories number 7: therapeutic products, cosmetics, health foods, health supplements, medical devices, traditional medicines, and brand and labelling approval.

The official account-opening process has three steps: the company registers on the portal and submits basic credentials → originals are verified by a DDF official → once verification passes, access is granted. The entry point reserved for companies on the portal home page reads “LOCAL COMPANY REGISTER” (local company registration).

GRZAN note: CamPORS went live on 1 August 2019 and covers 7 registrable categories; account opening takes 3 steps, of which step 2 is the in-person verification of originals by a DDF official.

2. Legal basis

3. Expert insights

1. The label “LOCAL COMPANY REGISTER” answers the eligibility question at the account level. By naming its entry point local company registration outright, CamPORS completes the entity-eligibility screen at the account stage. An overseas manufacturer cannot obtain an account by bypassing this step, however complete its overseas credentials — this is how the rule that “overseas manufacturers cannot file on their own” is enforced at system level.

1. Original verification is an offline action and cannot be replaced by post or electronic means. A DDF official must verify the company registration certificate, the drug import-export enterprise licence and other originals in person. This step requires the local entity to genuinely exist and to have a verifiable operating presence inside Cambodia; shell arrangements are unlikely to pass.

1. The word “Pharmaceutical” in the system’s name does not mean devices are excluded. This point causes repeated misjudgements in practice. The official documentation lists the 7 registrable categories item by item, with medical devices as a separate entry. Device applications are submitted through the medical device application module in CamPORS, alongside the pharmaceutical module.

4. Practical recommendations

1. Treat account opening as the project’s first milestone, not a parallel task. Investing in translation, notarisation and technical dossier compilation before the account is opened means a full redo if entity verification fails. Complete a self-check of entity qualifications first, then start dossier preparation.
2. Assemble the list of originals for verification in advance. At a minimum: the company registration certificate (issued by the Ministry of Commerce), the drug import-export enterprise licence (issued by the Ministry of Health), and proof of the registered pharmacist’s membership of the Pharmacy Council of Cambodia. Ask the local entity to produce an originals checklist annotating each item’s validity period.
3. Record the account opening date in writing. The opening date sets the starting point for every subsequent deadline and is the baseline for judging whether a committee window has been missed. Ask the local entity to issue a written confirmation of the opening.

5. Verification checklist

• □ Local company online registration on CamPORS completed
• □ Originals such as the company registration certificate and drug import-export enterprise licence assembled
• □ Original verification by a DDF official passed
• □ Account access granted and the opening date recorded in writing
• □ Confirmed that device applications can be submitted through the CamPORS medical device module
• □ DDF official email and telephone recorded as the channel for verifying current practice

Regulatory information verified as of 29 October 2026.

In Southeast Asian markets, GRZAN’s core capabilities concentrate on three points. First, distinguishing 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 registration-number legal basis provided by the 1996 Law on Drug Management 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. Compliance certainty is therefore markedly 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 submission, regulatory communication and post-market reporting obligations, and assisting with the practical requirements for a Cambodian registered pharmacist and a drug import-export enterprise licence. Third, quality system and testing support: helping establish a quality management system that meets ISO 13485 requirements and organising the technical dossier under the ASEAN Common Submission Dossier Template (CSDT).

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