Cambodia medical device registration timeline
Source-linked clocksDepartment of Drugs and Food, Ministry of Health (Department of Drugs and Food) review clocks and end-to-end planning ranges, using the 4-class (A, B, C, D) — ASEAN Medical Device Directive; class A is recorded as low risk and class D as high risk in Article 4(1) classification system.
6 pathways6 of 6 clocks verifiedvalidity 3 years for the medical-equipment visa registration — the Ministry of Health's Public Service Information (2016 update) prints 'សុពលភាព ៣ឆ្នាំ' (validity 3 years) for this service and the official National Trade Repository procedure page states the same three years and a renewal at 70% of the original price, so the figure now rests on two Cambodian government publications rather than on consultancy pages. The TRC qualified-agent certificate is valid for two years and the TRC type approval for the lifetime of the model (G/LIC/N/3/KHM/6 §14), and those are radio and telecom certificates, not the device registration.MDSAP not acceptedreviewed 2026-09-16lib.ncdd.gov.kh
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| TRC qualified-agent certificate — importer, supplier and distributor of radiocommunication, telecommunication and ICT equipment(Application to the Telecommunication Regulator of Cambodia through its online portal by a firm registered in Cambodia; the certificate is a precondition for a type approval and for a restricted-goods import permit (Law on Telecommunications Article 16(a); Sub-Decree No. 110 ANK/BK Article 7(a))) Cambodia's notification states the certificate 'shall be approved within 15 business days by TRC' for an eligible application; the 15 is recorded in the registry's working-days unit, which is the basis the instrument itself uses. | 15 working days | 3-6 weeks | — | Verified |
| TRC type-approval certificate — per equipment model(Application to the TRC on the Prakas No. 208 basis, filed by a qualified agent and enclosing EMC, safety and RF test reports; the certificate is issued for each imported model and must exist before the equipment is imported (Law on Telecommunications Article 16(b); Sub-Decree No. 110 ANK/BK Article 7(b))) The notification states the type-approval certificate 'shall be approved within 15 business days'. The application route is still processed manually and the TRC states it will move the service to its online portal. | 15 working days | 3-8 weeks | — | Verified |
| TRC import permit — restricted radiocommunication and ICT goods(Application through the National Single Window for goods in Annex 2 of Sub-Decree No. 370 ANK/BK of 28 December 2023, filed by a qualified agent and supported by an existing type approval for the model) The notification states the permit 'shall generally be approved by TRC within 3 business days through the National Single Window online system', and that it is granted within 3 business days where the goods already hold a type approval and the documents are complete. | 3 working days | 1-3 weeks | — | Verified |
| Class A, B, C and D — Department of Drugs and Food medical-equipment visa registration (វិញ្ញាបនបត្រទិដ្ឋាការ បញ្ជីការ សម្ភារៈ បរិក្ខារពេទ្យ)(Dossier filed with the Department of Drugs, Food, Medical Equipment and Cosmetics through the One Window Service Office of the Ministry of Health, on the attachment list the service schedule publishes (GMP/ISO certificate, Free Sale certificate, sterility and Certificate-of-Analysis documents) and the ASEAN Common Submission Dossier Template route of AMDD Article 8(a); registration is per medical-equipment product and the certificate is valid three years) MANDATORY CAVEAT — THIS IS A 2016 AUTHORITY-PUBLISHED SERVICE STANDARD, NOT AN ARTICLE OF THE IN-FORCE PRAKAS. The Ministry of Health's Public Service Information (2016 update) populates the 'រយៈពេលផ្តល់ជូន' (period provided) field for this service with 3-4 months and decomposes it into four one-month stages — examination of the documents and return to the company; preparation of the visa sub-committee meeting; preparation of the deciding committee meeting; and issue of the certificate once the committee has agreed. Four one-month stages are exactly the upper bound of the range. The device visa-registration procedure was re-promulgated by the Department of Drugs and Food in 2025, and that prakas is published only as a four-page image-only scan with no text layer, so it could not be read and could not be checked against this figure. If it restates, changes or drops the standard, its text governs; nothing here should be read as the statutory maximum. | 3-4 months | 3-8 months | — | Verified |
| Any class — Department of Drugs and Food import licence, per consignment (pharmaceuticals, medical materials and traditional medicines)(Application to the Department of Drugs and Food, Ministry of Health, at any time and with no advance application required; the licence is considered and granted by a single organ, the DDF, and importation may take place immediately after issue) Cambodia's own import-licensing notification, §11 item 7(a): 'No advance application is required; licenses can be applied for at any time. Licenses are often issued for landed goods. Licenses can be obtained in ten working days, if the application and supporting documents are complete. Importation may take place immediately after the issuance of a license.' Item 7(b) restates it on the legal basis of Prakas No. 093 of 9 February 2015 amending Prakas No. 1031 on Drug Import-Export Procedures, read with Joint Prakas No. 1356 of 18 November 2016: 'the timeline is ten working days'. | 10 working days | 2-4 weeks | — | Verified |
| MME/DONST permission letter to import radioactive substances and radioactive sources, and the underlying licence to use them(Application to the One Window Service Office of the Ministry of Mines and Energy by a public legal entity or a firm, under Prakas No. 0126 of 1 April 2021 on the Management of Import and Use of Radioactive Substances and Radioactive Sources, read with Inter-Ministerial Prakas No. 489 of 24 July 2024 on the Public Service of the Ministry of Mines and Energy; the General Department of Energy reviews the documents, evaluates on site, reports on technical safety and security, and submits to the Minister for decision) Cambodia's own import-licensing notification, §13 'RADIOACTIVE CHEMICAL ELEMENTS AND ISOTOPES; NUCLEAR REACTORS, INSTALLATIONS AND APPARATUS', item V, restated at item 8: a legal entity applying for a permission letter to import and use radioactive substances and radioactive sources 'shall get the written response on the approval or the rejection of the application no later than 45 (forty-five) days from the dated of which the complete and adequate application form has been received (by the official from the OWSO)'. The instrument states 'days', not working days, and is recorded in the days unit. | 45 days | 2-4 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
Cambodia Medical Device Registration Process
Step-by-step Department of Drugs and Food registration process. Total estimated timeline: 3-6 weeks.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by Department of Drugs and Food. Appoint a Cambodian-registered firm — only firms registered in Cambodia may hold the TRC qualified-agent certificate (Law on Telecommunications Article 16(a); Sub-Decree No. 110 Article 7(a)), and the Directive requires the person responsible for placing devices on the market to be licensed by the national Authority (AMDD Article 7).
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to Department of Drugs and Food including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksDepartment of Drugs and Food reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
15 working daysIn-depth technical assessment of device safety and performance. Department of Drugs and Food may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, Department of Drugs and Food issues Cambodia market authorization certificate.
Summary: The Cambodia medical device registration process through Department of Drugs and Food, Ministry of Health (Department of Drugs and Food) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
Prior approval recognition
Another ASEAN member state's device registration under the AMDD and the Common Submission Dossier TemplateThe Directive harmonises the dossier, not the decision: Article 6(1) makes a device placeable on a Member State's market after assessment by that Member State's Regulatory Authority, and Article 6(2) requires registration with that same Authority. Cambodia's round-204 research recorded the CSDT position as harmonized_dossier_only, and no instrument retrieved in this round states that a registration issued by another ASEAN member is accepted in place of DDF registration; the CSDT-aligned technical file is reusable as dossier content, and nothing more is claimed here.
Key requirements
- A medical device placed on the Cambodian market must be registered with the national Regulatory Authority (AMDD Article 6(2)), and the person responsible for placing it on the market must be licensed by that Authority (AMDD Article 7).
- File the medical-equipment visa-registration dossier through the One Window Service Office of the Ministry of Health, on the attachment list the Ministry's own public-service schedule publishes for that service (Good Manufacturing Practice or ISO certificate, Free Sale certificate, sterility and Certificate-of-Analysis documents), and hold the certificate for three years before renewing it.
- A consignment of medical materials or devices additionally takes a Department of Drugs and Food import licence, applied for at any time with no advance application, granted by the DDF alone, and obtainable in ten working days where the application and supporting documents are complete (G/LIC/N/3/KHM/6 §11).
- The device dossier follows the ASEAN Common Submission Dossier Template in Annex 4 of the Directive, which Member States undertook to adopt under Article 8(a); the product-owner or manufacturer declaration of conformity follows the harmonised elements in Annex 6.
- The device must meet the essential principles of safety and performance in Annex 1, and conformity with technical standards recognised by the ASEAN Medical Device Committee or accepted by the national Authority is deemed to comply with those principles (Articles 3 and 9(1)).
- Devices are classified on the AMDD A–D axis and, where a device could fall into two or more classes, it takes the class representing the highest health risk to the end user (Article 4(2)); combined devices are classified separately (Article 4(3)) and multi-purpose devices by their most critical intended purpose (Article 4(4)).
- Custom-made devices are not subject to product registration (Article 6(4)); a Member State may exempt other devices from registration and may authorise the use of unregistered devices in the interest or protection of public health (Articles 6(2) and 6(5)).
- Labelling follows the requirements of the Member State before placing on the market, and Member States may require the label in their national language (Article 10).
- A device that is radiocommunication, telecommunication or ICT equipment needs a qualified-agent certificate, a type approval for the model, and — where its heading is in Annex 2 of Sub-Decree No. 370 — an import permit, all from the TRC.
- A device that is an irradiating apparatus or uses radioactive sources needs an MME/DONST licence and import permit, with a radiation safety officer and an approved emergency plan.
Primary regulator sources
lib.ncdd.gov.kh · ព័ត៌មានសេវាសាធារណៈរបស់ក្រសួងសុខាភិបាល និងបច្ចុប្បន្នភាពឆ្នាំ២០១៦ — Ministry of Health Public Service Information, 2016 update, pp. 44-45: the medical-equipment visa-registration service, its 'រយៈពេលផ្តល់ជូន' period of 3-4 months, its four one-month stages and its three-year validity docs.wto.org · WTO document G/LIC/N/3/KHM/6, submitted by Cambodia under Article 7.3 of the Agreement on Import Licensing Procedures (communication dated 31 March 2025) — §11 Pharmaceuticals, medical materials and traditional medicines (DDF import licence, 10 working days), §13 Radioactive chemical elements and isotopes (MME permission letter, 45 days) and §14 Radiocommunication and ICT products docs.wto.org · WTO document G/LIC/N/3/KHM/6, submitted by Cambodia under Article 7.3 of the Agreement on Import Licensing Procedures (communication dated 31 March 2025) — §14 Radiocommunication and telecommunication products, and information and communication technology (ICT) related products: TRC processing periods, the Prakas No. 499 fee tariff and certificate validity asean.org · ASEAN Medical Device Directive — Article 6(2) registration with the Regulatory Authority of the Member State, Article 7 licensing of the person responsible for placing devices on the market, and Article 8(a) adoption of the Common Submission Dossier Template iaea.org · Kingdom of Cambodia national report to the Convention on Nuclear Safety (Ministry of Mines and Energy, August 2022), Articles 7.2, 9 and 15: MME/DONST licensing and import permits for radioactive substances and ionizing-radiation sources
Reviewed 2026-09-16. End-to-end totals remain planning estimates.
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Source-linked review clocks verified against Department of Drugs and Food publications · full review 2026-09-16 · row IDs are stable — cite as registration-timeline:cambodia:trc-qualified-agent-certificate