柬埔寨医疗器械注册六步流程全景

1. Key takeaways

Medical device registration in Cambodia can be broken down into six steps; the first three determine “whether the dossier can be submitted”, and the last three determine “how long it takes to obtain the certificate”:

1. Classification — determine the A/B/C/D class under AMDD Annex 2 (non-IVD) or Annex 3 (IVD); for multi-purpose devices, take the most critical intended use under Article 4(4);
2. Opening a CamPORS account — the local company registers online and submits credentials; originals are verified by a DDF official before access is granted;
3. Dossier preparation — administrative documents (application form, LoA, DoC, ISO/GMP certificates, company documents, labelling) are prepared as paper originals, while technical documentation is compiled to CSDT as an electronic copy on a USB drive;
4. Hybrid submission — online data entry + paper originals + USB technical dossier, delivered to DDF in parallel;
5. Fee payment — DDF notifies the applicant to pay once its assessment is complete; after payment, the application enters committee review;
6. Final committee approval and certificate issuance — the DDF committee meeting makes the final approval; once approved, the registration certificate is issued.

GRZAN note: registration in Cambodia involves 6 steps; the technical dossier follows 1 template (the 7 modules of the ASEAN CSDT); final approval rests with the DDF committee, whose meeting cycle is roughly 3 to 4 months.

2. Legal basis

3. Expert insights

1. Cambodia’s process bottleneck is not the volume of documents but the “window”. Of the six steps, the least controllable is step 6 — the DDF committee meets roughly every 3 to 4 months to make final approvals; if the assessment is not completed before the current meeting, the application is carried over to the next round. This means every missed window costs 3 to 4 months. The marginal return on polishing documents is far lower than the marginal return on managing the schedule.

1. “Hybrid submission” is the product of a paper era overlapping a digital one. CamPORS was designed for a fully paperless process, but for devices the authorities still require paper originals of the administrative documents and a USB copy of the technical dossier. This is not an option that can be simplified away — it is the currently accepted submission format at DDF; preparing purely online or purely on paper will lead to rejection.

1. Payment falls “after assessment is complete and before committee review”, which makes it a useful information node. The appearance of the payment notice means DDF’s technical assessment has concluded and the application is about to enter committee scheduling. For project management, this is the only public signal that allows backward calibration of the schedule — applicants should count back from the date of the payment notice to the next committee window.

4. Practical recommendations

1. Schedule the submission date backwards from the committee calendar. First confirm with the local entity the actual meeting months of the three most recent committee meetings, then derive the document freeze date from those; do not fix the document completion date first and then wait for meetings.
2. Make “passing pre-review on the first attempt” the single quality objective. Because there is no inter-department appeal buffer, the cost of a rejected pre-review is not a few days but possibly an entire missed committee window. A full third-party dossier pre-review before submission is recommended.
3. Set milestones and owners for each of the six steps. Classification is owned by regulatory affairs, the account by the local entity, dossier preparation jointly by regulatory and translation teams, submission by the local entity, payment with finance support, and schedule tracking by the project manager. The six steps span three organisations; without clearly assigned owners, waiting is inevitable.

5. Verification checklist

• □ Classification into A/B/C/D completed and documented in writing
• □ CamPORS account opened (originals verified by DDF)
• □ Paper administrative dossier and USB technical dossier both complete
• □ Hybrid submission completed: online entry + paper + USB
• □ DDF payment notice received and fee paid
• □ Committee meeting schedule tracker established and submission date back-planned

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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