Cambodia DDF CamPORS Medical Device Registration: Step-by-Step Guide

Quick answer

Medical devices sold or imported into Cambodia must be registered with the Department of Drugs and Food (DDF) under the Ministry of Health (MOH). The legal framework is Prakas No. 1258 (8 November 2012) on Procedures for Registration of Medical Devices, which aligns Cambodia with the ASEAN Medical Device Directive (AMDD) risk-class framework (Classes A–D). Applications are submitted through CamPORS (Cambodia Pharmaceutical Online Registration System) at https://ddf.moh.gov.kh/public/, using the Medical Device Application module. Only a locally registered company may file; foreign manufacturers must work through a local representative or a Cambodian entity with the required pharmaceutical licence and registered pharmacist. You submit an administrative hard-copy dossier plus a CSDT-aligned technical file on USB. After DDF evaluation, the government fee is KHR 400,000 (approximately USD 100). Final approval is decided at DDF committee meetings held roughly every three to four months. Registration certificates are typically valid for three years and are renewed through a new application. Plan 12–18 months end-to-end, depending on dossier quality and committee scheduling.

Who this applies to

This registration pathway applies to:

• Foreign manufacturers seeking to place medical devices on the Cambodian market through a local applicant
• Local importers and distributors acting as the registration holder
• Domestic manufacturers supplying medical devices within Cambodia
• Regulatory affairs teams preparing ASEAN CSDT dossiers for Cambodia as part of a multi-market strategy

Device scope covers medical devices as defined under Prakas 1258 and the AMDD-aligned classification system:

CamPORS also handles therapeutic drugs, cosmetics, health supplements, and traditional medicine, but this guide focuses on the Medical Device Application module.

Legal basis: Prakas No. 1258 and AMDD alignment

Prakas No. 1258 (issued 8 November 2012) establishes the procedures for registration of medical devices in Cambodia. It is the primary regulatory instrument cited by MOH and DDF for market access of medical devices.

Key principles from the Prakas framework include:

• Medical devices must be registered with DDF before import and distribution
• Devices are classified under an AMDD-aligned A–D system, allowing consistency with neighbouring ASEAN markets
• The registration holder must be a Cambodian legal entity
• Technical documentation must demonstrate safety, quality, and performance for the labelled intended use
• Labelling must be in Khmer or English

Prakas 1258 works together with MOH enforcement of pharmaceutical and health-product rules. CamPORS, launched on 1 August 2019, operationalises the registration workflow as a paperless portal while retaining physical dossier elements for administrative and technical review.

CamPORS portal: what it does and how to access it

CamPORS (Cambodia Pharmaceutical Online Registration System) is the official MOH/DDF online registration platform at:

https://ddf.moh.gov.kh/public/

CamPORS supports registration of:

• Therapeutic drugs
• Cosmetics
• Health supplements
• Medical devices
• Traditional medicine

For medical devices, use the Medical Device Application module after your company account is verified.

Portal workflow overview

CamPORS is designed for paperless dossier management at the portal level, but DDF still requires physical submission of the administrative hard-copy package and the USB technical file—a hybrid model common in ASEAN transition markets.

Local applicant requirement: who can submit

Only a locally registered company in Cambodia may submit a medical device registration application through CamPORS. A foreign manufacturer cannot file directly as an overseas entity.

Two practical setup routes exist:

Route A: Appoint a local representative

A foreign manufacturer appoints an existing Cambodian company—typically an importer or distributor—as its local representative and registration applicant. This entity:

• Holds the CamPORS company account
• Submits the Medical Device Application
• Receives DDF correspondence and the registration certificate
• Bears responsibility for post-registration obligations in Cambodia

A formal Letter of Authorization (LoA) from the manufacturer to the local applicant is required in the administrative dossier.

Route B: Establish a local company

A manufacturer or group may incorporate a Cambodian entity and obtain:

1. Ministry of Commerce (MoC) incorporation — legal company registration
2. MOH pharmaceutical company licence — authorisation to operate as a pharmaceutical/health-product company
3. Registered pharmacist — a qualified pharmacist registered in Cambodia associated with the entity

This route suits companies planning long-term direct market presence but requires greater local infrastructure.

Dossier structure: hard copy plus USB CSDT

Cambodia follows the ASEAN Common Submission Dossier Template (CSDT) for technical documentation. The submission is split into two physical components plus online data entry in CamPORS.

Administrative hard-copy dossier

Submit a bound hard-copy package to DDF containing:

• Completed application form (CamPORS-generated or DDF-specified format)
• Letter of Authorization (LoA) — manufacturer to local applicant, signed and dated
• Declaration of Conformity (DoC) — statement that the device meets applicable requirements
• ISO 13485 certificate or equivalent quality management system evidence for the manufacturing site
• GMP / manufacturing licence evidence where applicable
• Free Sale Certificate (FSC) or Certificate of Pharmaceutical Product from the country of origin, where required
• Company registration documents — MoC certificate, pharmaceutical licence, pharmacist registration
• Labelling samples — in Khmer or English
• Power of attorney — if a third party submits on behalf of the applicant

Technical file on USB

Prepare a USB drive containing the CSDT-aligned technical dossier, typically structured as:

Ensure the USB is readable, virus-free, and clearly labelled with device name, applicant, and application reference.

Government fee, timeline, and certificate validity

Fee

After DDF completes its initial evaluation, the applicant receives notification to pay the government registration fee of KHR 400,000 (approximately USD 100 at prevailing exchange rates). Fee payment is required before the application proceeds to committee review.

Timeline

Industry planning assumptions commonly cite 12–18 months from first submission to certificate issuance. Actual duration depends on:

• Dossier completeness — incomplete CSDT sections trigger queries and reset review clocks
• Query response time — delays in answering DDF deficiency letters extend timelines
• Committee schedule — DDF committee meetings occur roughly every three to four months; missing a cycle adds months
• Device class — higher-risk Class C and D devices may face deeper clinical and technical scrutiny

Certificate validity and renewal

Registration certificates issued by DDF are typically valid for three years. Renewal is handled through a new application submitted before expiry, with updated technical documentation, quality cert...