Department of Drugs and Food · structured requirements

🇰🇭 Cambodia medical device regulatory data

Explore the medical device requirements currently available for Cambodia, organized by topic and linked to official sources.

41 facts22 dimensions10 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Medical device claims are subject to regulatory control and must be justified by substantial evidence

advertising.medical-device-claims-regulatory-control

Fact-level verified

Medical device claims are subject to the regulatory control of the Member States, and as a general rule the claimed benefits of a device must be justified by substantial evidence or by the device's composition, formulation, component or preparation itself, in accordance with the essential principles of safety and performance. This is the device-specific claims rule binding Cambodia.

Conditions

The instrument states the principle but does not itself create a claim-approval procedure, a pre-clearance requirement or a list of prohibited claims; no Cambodian device claim-preclearance procedure was retrieved.
Applies in Cambodia through its Instrument of Acceptance of the ASEAN Medical Device Directive, deposited 27 March 2019.

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English. Quoted verbatim. This is the only provision retrieved that names medical-device claims expressly.

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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When a variation changes certificate particulars a new certificate is issued dated from its issue but keeping the original expiry date (Prakas 4206, Art. 7)

validity.certificate-reissued-after-variation-keeps-original-expiry

Fact-level verified

Under Article 7 of Prakas 4206, if a variation affects information printed on the visa-registration certificate, a new certificate is issued counted from its own date of issue while retaining the original expiry date, and the original certificate must be returned with the application; variations that do not affect certificate particulars are filed with a copy of the certificate.

Conditions

Applies to products within the prakas' definition of pharmaceutical products, which includes medical devices and reagents (Art. 4).

English gist: copy of the certificate where the variation does not touch certificate particulars; where it does, a new certificate is issued from its issue date but keeps the same expiry date, and the original certificate must be attached.

The DDF renewal template requires a copy of the most recent device/reagent certificate and states the renewal round number (DDF sample renewal letter)

validity.renewal-application-attaches-last-certificate

Fact-level verified

The DDF sample letter for renewal of validity of a device/reagent registration ('សំណើសុំបន្តសុពលភាពបញ្ជិកា…លើកទី…') carries a product table with an 'Old License No.' column and lists, in addition to the initial-application attachments, the most recent device/reagent registration certificate.

Conditions

Template practice; the legal basis for renewal is Prakas 1258 Art. 9.

English gist: 'Subject: request to renew the validity of the registration of … medical devices/reagents, renewal no. …'; table includes 'Old License No.'; attachment: the last device/reagent registration certificate, one copy.

The three-year certificate runs from its issue date and the holder must file the renewal dossier (Arts. 5–7 documents) six months before expiry (Prakas 1258, Art. 9)

validity.renewal-filed-six-months-before-expiry-with-full-dossier

Fact-level verified

Article 9 of Prakas 1258 fixes the validity of a medical/dental device visa-registration certificate at three years counted from the date the certificate number is issued, and requires the company, six months before expiry, to complete and submit the renewal application to the Ministry of Health with the documents set out in Articles 5, 6 and 7.

Conditions

Renewal dossier = the same class-based document lists as an initial application plus the labelling requirements of Art. 7.
No post-expiry grace period is provided.

Effective from 2012-11-08

English gist: Article 9 — the device visa-registration certificate is valid 3 years from the date its number is issued; 6 months before expiry the company must complete and file the renewal formalities with the MoH as provided in Articles 5, 6 and 7. Transcribed from the scanned Khmer original (checked against the page image). Closes the renewal-window gap left in the existing validity fact.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Variations are classed as major, minor or simplified minor according to the MoH Guideline on product variations of 26 March 2019, which serves as the technical reference (Prakas 4206, Arts. 4–5)

change.major-minor-and-simplified-minor-variations-per-2019-guideline

Fact-level verified

Article 4 defines a product variation as an update covering major and minor variations: a major variation is one that may strongly and/or directly affect quality, safety and efficacy (guideline point 7); a minor variation is administrative or a small change that does not strongly and/or directly affect quality, safety and efficacy (point 8); a simplified minor variation is an administrative or small change that does not affect quality, safety and efficacy (point 9). Article 5 adopts the Guideline on variations of pharmaceutical products dated 26 March 2019 as the technical document for the procedure.

Conditions

The 26 March 2019 guideline itself was not retrieved; its device-specific variation categories remain to be read.

English gist: major variation = may strongly/directly affect quality, safety, efficacy (guideline point 7); minor = administrative or small change not strongly/directly affecting them (point 8); Art. 5 adopts the 26 March 2019 variation guideline as the technical document.

Devices differing in trade name, presentation, size or manufacturing plant must be registered separately (Prakas 1258, Art. 10)

change.separate-registration-for-different-name-presentation-size-or-plant

Fact-level verified

Article 10 of Prakas 1258 provides that medical and dental devices with a different trade name, presentation, size or manufacturing plant must each hold a separate visa registration, so such differences cannot be handled as variations of one registration.

Conditions

Read together with Prakas 4206, which governs variations to an existing registration.

Effective from 2012-11-08

English gist: Article 10 — medical and dental devices having a different trade name, presentation, size or manufacturing plant must be visa-registered separately.

Varying a registered product without authorisation exposes the holder to suspension, withdrawal or cancellation of the certificate or a fine under the Law on the Management of Pharmaceuticals (Prakas 4206, Art. 11)

change.unauthorised-variation-suspension-withdrawal-or-fine

Fact-level verified

Article 11 provides that where the certificate holder is found to have varied a product without authorisation, the Ministry of Health may suspend, withdraw or cancel the visa-registration certificate or impose an intermediary fine under the Law on the Management of Pharmaceuticals.

Conditions

Sanction basis is the pharmaceutical management law, which also governs devices in Cambodia.

English gist: unauthorised variations → MoH may suspend, withdraw or cancel the certificate, or impose an intermediary fine, under the Law on the Management of Pharmaceuticals.

A variation is filed by the licensed manufacturer, import-export establishment or representative office with an application in Khmer, the certificate, a letter of reasons and the guideline's technical documents (Prakas 4206, Arts. 6–7)

change.variation-dossier-contents-and-eligible-applicants

Fact-level verified

Variation requests may be made through a manufacturing establishment, a pharmaceutical import-export establishment or a representative office holding a Ministry of Health decision (Art. 6). The dossier comprises the application in the national language, the visa-registration certificate (copy, or the original where the variation affects certificate particulars), a letter from the certificate holder explaining the reasons for the variation, and the technical documents specified in Article 5 (Art. 7).

Conditions

Application must be in Khmer ('ជាភាសាជាតិ').

English gist: Art. 6 — variations may be requested through manufacturers, import-export establishments or representative offices holding an MoH decision; Art. 7 — dossier: application in the national language; certificate (copy/original as applicable); letter of reasons from the certificate holder; technical documents per Art. 5.

Prakas 4206 establishes the post-registration variation procedure and defines the products covered to include medical devices and reagents (Arts. 1, 3–4)

change.variation-procedure-prakas-4206-covers-medical-devices-and-reagents

Fact-level verified

Prakas No. 4206 ABS/OABS authorises variations to products that already hold a Ministry of Health visa-registration certificate, on the basis of information, evidence and specific documents from the certificate holder justifying the change (Art. 1); it applies to products whose certificate is still valid (Art. 3); and for its purposes 'pharmaceutical products' means modern medicines, traditional medicines, vaccines, health supplements, health-support products, medical devices and reagents (Art. 4, last paragraph).

Conditions

Repeals Prakas 149 SNBO of 23 September 1996 on the procedure for varying pharmaceutical visa registrations (Art. 12).
Preamble cites Prakas 1258/2012 on device visa registration and Joint Prakas 1356/2016 on MoH fees.

English gist: Art. 1 — purpose: to permit variations to pharmaceutical products already holding an MoH visa-registration certificate, through information supported by evidence and specific documents justifying the change, from the certificate holder. Art. 4 (end) — 'pharmaceutical products' means modern medicines, traditional medicines, vaccines, health supplements, health-support products, medical devices and reagents. Transcribed from the scanned Khmer original (checked against the page images).

Variations not provided for in the variation guideline require a fresh visa-registration application (Prakas 4206, Art. 10)

change.variations-outside-guideline-require-new-registration

Fact-level verified

Article 10 provides that any variation procedure not set out in the Guideline on variations of pharmaceutical products obliges the certificate holder or manufacturer to apply for a new visa-registration of the product.

Conditions

Prakas 1258 Art. 10 separately requires separate registrations for devices with a different trade name, presentation, size or manufacturing plant (companion fact).

English gist: variation procedures not covered by the guideline mean the certificate holder or manufacturer must apply for a new visa-registration of the product. Transcribed from the page image (the OCR of this article was garbled and was corrected against the scan).

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical evidence may come from investigations conducted domestically or in other countries

clinical.foreign-or-domestic-clinical-evidence

Fact-level verified

In the common submission dossier, clinical evidence of effectiveness may comprise medical device-related investigations conducted domestically or in other countries, and may be derived from relevant publications in peer-reviewed scientific literature, with the submitted evidence documenting objectives, methodology and results in context. Foreign clinical evidence is therefore accepted; the instrument states no requirement for a local investigation as a condition of registration.

Conditions

The clause is permissive about where the investigations were conducted and does not name the countries whose data are accepted.
Clinical investigation is stated to be most likely needed for higher risk class devices or where there is little or no clinical experience with the device.
Applies in Cambodia through its Instrument of Acceptance of the ASEAN Medical Device Directive, deposited 27 March 2019.

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English. Quoted verbatim from the ASEAN Common Submission Dossier Template annex.

A device for clinical investigation may be required to be registered with the authority where the investigation is conducted

clinical.investigation-registration-with-authority

Fact-level verified

For medical devices intended for clinical investigation, the Regulatory Authority of the Member State may require the product owner, its authorised representative or the sponsor of the clinical investigation to follow the Annex 8 clinical-investigation procedure and to register with the Regulatory Authority of the Member State in which the investigations are to be conducted. The authority may also require the investigation report to be submitted or made available on request, and must be notified of the end of the investigation with justification where it was suspended or terminated early.

Conditions

The obligation is framed as a power of the Regulatory Authority ('may require'), not as an automatic standing requirement.
The annex takes the Helsinki Declaration as its baseline for the protection of human subjects.
No Cambodian clinical-investigation application form, fee or clock was retrieved.

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English. Quoted verbatim.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Products expressly outside the device regime

scope.excluded-products

Fact-level verified

Human blood, plasma or blood cells of human origin and devices incorporating them, transplants or tissues or cells of human origin and products incorporating or derived from them, and transplants or tissues or cells of animal origin are outside the device instrument, except where the material is incorporated in an IVD device, where human blood material is incorporated as a human blood derivative with an action ancillary to that of the device, or where the animal tissue is rendered non-viable. Mass-produced devices adapted to a practitioner's specific requirements are expressly not custom-made devices.

Conditions

Applies in Cambodia through its Instrument of Acceptance of the ASEAN Medical Device Directive, deposited 27 March 2019.
The instrument also defines 'custom-made medical device' and 'device intended for clinical investigation' and excludes mass-produced adapted devices from the custom-made category.

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English. Quoted verbatim; the custom-made clarification is the second paragraph of sub-paragraph (f).

Definition of a medical device and of an accessory, and treatment of accessories as devices

scope.medical-device-and-accessory-definition

Fact-level verified

The instrument binding Cambodia defines a 'medical device' as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or other similar or related article intended by the product owner to be used on human beings for a listed medical purpose and which does not achieve its primary intended action by pharmacological, immunological or metabolic means; an 'accessory' is an article intended specifically to be used together with a particular device to enable or assist its use; accessories are treated as medical devices in their own right, and both are referred to as devices. The listed purposes expressly include providing information for medical or diagnostic purposes by means of in-vitro examination of specimens derived from the human body, so software and IVDs fall within the single definition.

Conditions

Applies in Cambodia through its Instrument of Acceptance of the ASEAN Medical Device Directive, deposited 27 March 2019; the Agreement entered into force on 1 January 2015 among the Member States that had ratified or accepted it.
The definition is the ASEAN definition, not a stand-alone Cambodian statutory definition; no Cambodian instrument carrying its own device definition was retrieved.
Borderline and excluded categories are recorded separately in this file (see scope.excluded-products).

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English (ASEAN Secretariat publication). Quoted verbatim from the text layer of the 106-page PDF.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Technical documentation follows the ASEAN CSDT

dossier.asean-csdt-technical-document

Fact-level verified

Technical documentation for a device submitted under the ASEAN framework must follow the ASEAN Common Submission Dossier Template (Annex 4 to the AMDD), which Member States are required to adopt and implement as a common technical document, together with the post-marketing alert system (Annex 5) and the harmonised Declaration of Conformity elements (Annex 6).

Conditions

The CSDT is the common technical document; it does not replace the national administrative dossier.
The national administrative dossier is now known: the visa-registration attachment set published by Cambodia's National Trade Repository, which for risk classifications 2, 3 and 4 requires the application form, a GMP or international-standard certificate, a certificate of sale in the country of origin, a certificate of registration in other countries (if any), analytical securities, technical documentation and two sample products or brochures, and for classification 1 the same list without the analytical securities and the technical documentation (see supporting source).
Annex 6 §2 requires a signed and dated copy of the Declaration of Conformity to be submitted as part of product registration.

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification Application for Visa Registration Certificate for Medical Equipment (National Trade Repository import/export procedure)Requirement for visa registration of medical equipment (including imports) — National Trade Repository measure, Technical Code B14

Upgrade in place of the round-204 row of this key. That row's condition said Cambodia's own checklist 'is not published'; it is published on the National Trade Repository, so the condition above replaces that statement with the actual attachment set rather than repeating an absence that is no longer true. Excerpt quoted verbatim from the ASEAN Secretariat publication.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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The person responsible for placing devices on the market must be licensed

operators.person-responsible-must-be-licensed

Fact-level verified

The person responsible for placing medical devices on the Cambodian market must be licensed by Cambodia's regulatory authority before the devices are placed on the market, and each Member State must put in place an appropriate system for licensing that person.

Conditions

The AMDD leaves the identity, qualification and licence conditions of that person to each Member State; Cambodia's national licensing rule and licence instrument are not published in the sources read this round.
No Cambodian instrument requiring a locally registered company, local representative or authorised representative as a condition of device registration was retrieved.

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Upgrade in place of the round-204 row of this key: the row cited Art. 7 but was held at source-backed-partial for lack of an official text; the verbatim article and the deposited Instrument of Acceptance supply it. The round-204 condition relying on a CamPORS observation ('Portal registration is open only to locally registered companies') is not re-asserted because the portal is unreachable this round.

Fees

What regulator fee applies to this class, route, event, and date?

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The import permit for medicines, medical devices and cosmetics costs 200,000 riel per consignment, issued within 10 working days and valid six months (Joint Prakas 1356/2016 Annex 1 row 11; NTR Note 4)

fees.import-permit-200000-riel-per-consignment

Fact-level verified

Annex 1 row 11 of Joint Prakas 1356/2016 prices the letter authorising import of medicines, medical devices and cosmetics at 200,000 riel, with a 10-working-day maximum service time and a validity of one month (the annex's validity column reads ១ខែ).

Conditions

Per import application (consignment).
Validity taken from the NTR page; the gazette validity column for this row is not legible enough on the scan to transcribe.
The National Trade Repository procedure page describes the import certificate's validity as six months; the gazetted annex column reads one month, and the gazette is followed here.

Effective from 2016-11-18

English gist: row 11 'issuance of the letter authorising import of medicines, medical devices and cosmetics — 200,000 riel — 10 days'. NTR Note 4 (r210-kh-ntr-proc-import-certificate): 'The service fee of 200,000 Riel for a request to import medicine/cosmetics/medical equipment, is valid for 6 months.'

The fee for a variation application is the one fixed by joint prakas of the Ministers of Health and of Economy and Finance (Prakas 4206, Art. 8)

fees.variation-fee-set-by-moh-mef-joint-prakas

Fact-level verified

Article 8 of Prakas 4206 provides that the service fee for a request to vary a product holding a visa-registration is determined by joint prakas between the Minister of Health and the Minister of Economy and Finance.

Conditions

No device-specific variation fee row was located in the 2016 tariff; the applicable joint-prakas line remains to be identified.

English gist: the fee for variation applications is set by MoH–MEF joint prakas.

The MoH public-service tariff prices the visa-registration certificate for medical devices/reagents at 400,000 riel, valid three years (Joint Prakas 1356/2016, Annex 1 row 8)

fees.visa-registration-certificate-400000-riel-joint-prakas-1356

Fact-level verified

Annex 1 of Joint Prakas No. 1356 MEF.PrK of 18 November 2016 (tariff of public services provided by the Ministry of Health) row 8 'issuance of a visa-registration certificate' prices medical devices, reagents, external-use health-support products, traditional medicines and health supplements at 400,000 riel per service unit, with a maximum service time of 100 working days and a validity of 3 years; the same row prices medicines at 1,000,000 riel, 270 working days and 5 years.

Conditions

Fee per certificate (unit price of the service).
The tariff pre-dates CamPORS; the NTR page and DDF practice still quote 400,000 riel.

Effective from 2016-11-18

English gist: row 8 'issuance of the visa-registration certificate for: – medicines 1,000,000 riel / 270 days / 5 years; – medical devices or reagents or external-use health-support products or traditional medicines or health supplements 400,000 riel / 100 days / 3 years'. Column headings: unit price of the service; maximum service time (working days); validity. Transcribed from the rotated scanned gazette page (OCR checked against the image).

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Mandatory and general label content of the applicable labelling annex

labelling.annex-7-content-elements

Fact-level verified

The labelling annex makes the product owner's name and contact details mandatory on the labelling, and requires the labelling of all devices to carry sufficient details to identify the device and, where not obvious, its intended purpose, user and patient population; a batch/lot number or serial number to allow trace and recall; a use-by date expressed at least as year and month where relevant, with storage conditions and shelf-life after first opening; the information needed to verify proper installation and safe operation including maintenance, quality control, consumable replacement and calibration; warnings, precautions, limitations or contra-indications; the performance intended by the product owner and undesirable side effects where relevant; special storage or handling conditions on the external packaging; and any further treatment or handling needed before use. The inclusion of the manufacturing site and of the importer's, authorised representative's or physical manufacturer's contact information is optional. Internationally recognised symbols are encouraged, with an explanation where a symbol is not obvious to the user.

Conditions

Paper versions of all labelling must accompany the device, as the case may be, in the Member State.
Instructions for use may be abbreviated or omitted for low or moderate risk devices that can be used safely without them.
Applies in Cambodia through its Instrument of Acceptance of the ASEAN Medical Device Directive, deposited 27 March 2019; Member States may apply Annex 7 or set their own requirements (Art. 10(2)).

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English. Quoted verbatim from the labelling annex. Annex 7 contains no language requirement of its own; the language option sits in Art. 10(3) and is recorded separately in this file.

Labelling must meet the placing Member State's requirements; the national-language requirement is optional for the State

labelling.member-state-requirements-and-language-option

Fact-level verified

A medical device must be labelled in accordance with the requirements of the Member State before it is placed on that State's market. Member States may set labelling requirements by reference to Annex 7 or as they deem appropriate, and may require the label to be in their national languages. Cambodia is therefore permitted to impose a Khmer-language label requirement but is not obliged to by the instrument.

Conditions

No Cambodian instrument, Prakas or DDF guidance imposing or waiving a Khmer-language label or instructions-for-use requirement was retrieved; no national-language requirement is asserted here.
The instrument also lists the labelling requirements themselves in Annex 7 (recorded separately in this file as labelling.annex-7-content-elements).
Applies in Cambodia through its Instrument of Acceptance of the ASEAN Medical Device Directive, deposited 27 March 2019.

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English. Quoted verbatim. Round 204 recorded the same negative for Cambodia (no retrieved instrument states the labelling language); this fact supplies the operative rule and the permissive language limb without asserting a Khmer requirement.

Legal basis & guidance

Which current law, regulation, guidance, and transition provisions apply?

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ASEAN Medical Device Directive in force for Cambodia from 27 March 2019

legal-basis.amdd-in-force-for-cambodia

Fact-level verified

Cambodia deposited an Instrument of Acceptance of the ASEAN Agreement on Medical Device Directive on 27 March 2019, as recorded by the ASEAN Secretariat's Treaty Division; because AMDD Art. 22(2) puts the Agreement in force only among Member States that have ratified or accepted it, the AMDD became binding on Cambodia on that date.

Conditions

Cambodia is one of nine of the ten AMDD signatory States that have deposited an instrument; Brunei Darussalam is the only signatory absent from the depositary table.
The AMDD's substantive obligations — registration with the national Regulatory Authority (Art. 6(2)), the four risk classes (Art. 4(1)), the CSDT dossier (Art. 8(a)) and post-marketing alert duties (Art. 12(3)) — therefore apply to Cambodia as treaty obligations, not merely as a model.
This is the regional instrument; no Cambodian Prakas or Sub-Decree transposing the AMDD was located on an official Cambodian domain (see unresolved legal-basis-guidance).

The record is the ASEAN Secretariat Treaty Division's own depositary database, which Art. 24 of the AMDD designates the Secretary-General to maintain ('This Agreement shall be deposited with the Secretary-General of ASEAN'). The table lists nine instruments: Cambodia 27 March 2019 (Instrument of Acceptance); Indonesia 26 December 2018; Lao PDR 04 December 2015; Malaysia 24 July 2020; Myanmar 06 September 2018; Philippines 04 March 2021; Singapore 02 November 2015; Thailand 19 January 2021; Viet Nam 23 March 2016. The same page states 'Status: In Force (IF)' and 'Date of Entry Into Force (EIF): 01 January 2015'. The site is behind a JavaScript bot-protection challenge; the page was retrieved by computing the challenge cookie its own script sets. Table row as rendered: No. 1. | Member State Cambodia | Date 27 March 2019 | Document Type Instrument of Acceptance.

ASEAN Medical Device Directive — Cambodian signature

legal-basis.asean-medical-device-directive-signature

Fact-level verified

Cambodia is a signatory of the ASEAN Agreement on Medical Device Directive (AMDD), signed at Bangkok on 21 November 2014; the instrument was signed for Cambodia by Sun Chanthol, Senior Minister and Minister of Commerce.

Conditions

Signature is not ratification: AMDD Art. 22(2) provides that the Agreement enters into force on 1 January 2015 and 'shall be in force only among the Member States that have ratified and/or accepted it'.
Cambodia's instrument of acceptance is dated 27 March 2019 per the ASEAN Secretariat depositary record (see legal-basis.amdd-in-force-for-cambodia); the AMDD therefore binds Cambodia only from that date, not from the 1 January 2015 entry into force of the Agreement itself.

Signature page of the ASEAN Secretariat publication (106-page PDF; the signature block sits on PDF page 29, printed page 23). Verbatim: 'Done at Bangkok, Thailand, this Twenty First Day of November in the Year of Two Thousand and Fourteenth in a single original copy in the English Language' and 'For the Kingdom of Cambodia: SUN CHANTHOL Senior Minister and Minister of Commerce'. Art. 22(2) (printed p. 22), relied on in the conditions, reads: 'This Agreement shall enter into force on 1 January 2015 and shall be in force only among the Member States that have ratified and/or accepted it.'

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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Dealer complaint-handling system and complaint-record retention of five years beyond projected useful life

pms.complaint-handling-and-record-retention

Fact-level verified

Dealers of medical devices must maintain records of complaint reports and of the actions taken in response, produce those records for inspection by the Regulatory Authority when requested, and establish and implement documented procedures to conduct effective and timely investigations of reported problems. Complaint records must be retained for a period of five years on top of the device's projected useful life as determined by the product owner, and all persons placing devices on the market must be vigilant for changes in trends or frequency of adverse events.

Conditions

The annex states these are recommended requirements that Member State Regulatory Authorities may adopt or replace with their own; no Cambodian adoption instrument was retrieved.
This is the post-market handling and record-keeping duty; the reportable-event, actor, channel and deadline duties are recorded separately under vigilance-incident-reporting, and the traceability records under udi-listing-traceability.
The annex applies to all medical devices including IVD medical devices (Annex 5 §1.3).

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English. Quoted verbatim.

Post-market clinical follow-up studies driven by residual risk, feeding the surveillance programme

pms.post-market-clinical-follow-up-studies

Fact-level verified

The need for post-market clinical follow-up studies is determined from identification of residual risks that may affect the risk/benefit ratio, with circumstances including innovation in design, materials, principles of operation or technology, novel medical indications, a new approved indication or claim, changes to device design or labelling, changes in medical practice, higher risk classification and high-risk anatomy. Such studies must have clearly stated objectives, a scientifically sound design with a rationale and statistical analysis plan, a study plan and implementation with analysis and conclusions. Their data and conclusions provide clinical evidence to support the post-market surveillance programme, and may require the manufacturer to reassess whether the device still complies with the essential principles, leading to corrective or preventive actions.

Conditions

Annex 8 states it does not cover IVD medical devices, so this fact is recorded for medical devices only.
The AMDD's post-market clinical follow-up annex is separate from the complaint-handling and alerting annex (recorded separately in this file).
Applies in Cambodia through its Instrument of Acceptance of the ASEAN Medical Device Directive, deposited 27 March 2019.

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English. Quoted verbatim.

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Visa-registration application documents for medical and dental devices must be written in Khmer, English or French (Prakas 1258, Art. 8)

forms.application-documents-in-khmer-english-or-french

Fact-level verified

Article 8 of Prakas 1258 requires the documents of an application for visa registration of medical and dental devices to be written in Khmer, English or French.

Conditions

Applies to the application dossier; labelling language is governed separately by Article 7.

Effective from 2012-11-08

English gist: Article 8 — documents applying for visa registration of medical and dental devices must be written in Khmer, English or French. Transcribed from the scanned Khmer original (OCR checked against the page image).

DDF publishes official sample application letters for medical-device/reagent registration, renewal and visa that cite Prakas 1258 and list the mandatory attachments

forms.ddf-sample-application-letters-for-device-registration-renewal-and-visa

Fact-level verified

The DDF website's 'sample application forms for visa/registration' folder contains a Word file with three letter templates addressed to the Minister of Health — a request for registration (បញ្ជិកា) of medical devices/reagents, a request for renewal of validity, and a request for a visa (ទិដ្ឋាការ) by a manufacturer or import-export establishment — each citing Prakas No. 1258 ABS/OABS of 8 November 2012 as its reference, containing a product table (product name, composition, purpose of use, pack size, manufacturer, MAH) and listing the attachments: five original application copies, a copy of the establishment-opening decision, a National Health Product Quality Control Centre analysis bulletin (for disinfectants), Free Sale Certificate, Certificate of ISO/GMP, Declaration of Conformity, Letter of Authorization, the technical file on USB, and a product sample or catalogue.

Conditions

The templates are letters signed by the establishment head and the responsible pharmacist; they complement, not replace, the CamPORS online submission.
The file is hosted on Google Drive but is linked from the official DDF home page.

English gist: Subject: request to register … medical devices/reagents. Reference: MoH Prakas 1258 ABS/OABS of 8 Nov 2012 on visa registration of medical devices. Attachments: 5 original application copies; copy of the decision opening the pharmaceutical import-export establishment; quality-analysis bulletin issued by the National Health Product Quality Control Centre (for disinfectants); FSC; ISO/GMP certificate; DoC; LoA; technical documents on USB; one sample device/reagent or catalogue. Text extracted from the .docx.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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ASEAN-level conformity assessment by the authority or appointed bodies, and the quality-assurance evidence required for each manufacturing facility

qms.conformity-assessment-and-manufacturing-facility-quality-assurance-evidence

Fact-level verified

The quality-system limb of Cambodian device control that is readable at instrument level is the ASEAN one. Article 5(1) of the ASEAN Medical Device Directive requires a medical device that is required to be assessed by a Member State and is intended to be placed on that Member State's market to be assessed by the Regulatory Authority of that Member State, or by any appointed bodies recognised by that Member State, for conformity and compliance with at least the requirements laid down in the Directive, unless the device is exempted from registration under Article 6(2); Article 5(2) requires Member States to put in place an appropriate system for that conformity assessment. Within the ASEAN Common Submission Dossier Template, section 4.6 requires the applicant to summarise, reference or contain documentation on the manufacturing processes, including quality assurance measures, appropriate to the complexity and risk class of the device, and section 4.6.1 requires that where multiple facilities are involved in the manufacture of the device, the applicable information for each facility — given as quality assurance certificates issued by an accredited third-party inspection body — must be submitted. The harmonised Declaration of Conformity elements likewise require the quality management system certificate to be identified by certification body, certificate number, issue date and expiry date, and the declaration to carry the date from which it is valid.

Conditions

This fact states the ASEAN-level rule that Cambodia applies as a party to the Directive; the Cambodian-specific overlay — the National Trade Repository measure stating that the visa-registration application for medical equipment must have a GMP or ISO certificate attached, with a reference to Articles 5 and 6 of Prakas No. 1258 — is a separate fact in this dimension and remains source-backed-partial.
The Directive's conformity assessment is carried out by the national Regulatory Authority or by appointed bodies recognised by the Member State; the Directive does not itself create an accreditation or designation procedure for those bodies, which is left to each Member State.
Read together with Article 6 (registration and placement on the market) and Article 7 (licensing of the person responsible for placing devices on the market), Articles 5 to 7 are the Directive's conformity-assessment, registration and licensing chain; Articles 5, 6 and 7 were each read in full in this wave.

Language of source: English (ASEAN Medical Device Directive, 2015, signed by Cambodia; the registry already holds this instrument as r209-kh-amdd-2014). Verbatim Article 5(1): "A medical device, which is required to be assessed by a Member State and intended to be placed on the market of that Member State, shall be assessed by the Regulatory Authority of that Member State, or any appointed bodies recognised by that Member State, as the case may be, for conformity and compliance with at least the requirements laid down in this Agreement unless the medical device has been exempted from the requirement for registration under paragraph 2 of Article 6." Article 5(2): "Member States shall put in place an appropriate system for the conformity assessment of medical devices as referred to paragraph 1 of this Article." Annex 4 §4.6: "This section should summarise or reference or contain documentation related to the manufacturing processes, including quality assurance measures, which is appropriate to the complexity and risk class of the medical device." Annex 4 §4.6.1, in fine: "If multiple facilities are involved in the manufacture of medical device, the applicable information (e.g. quality assurance certificates issued by an accredited third party inspection body) for each facility must be submitted. Firms that manufacture or process the medical device under contract to the product owner may elect to submit all or a portion of the manufacturing information applicable to their facility directly to the Regulatory Authority in the form of a master file." Annex 6 (harmonised set of elements for a Product Owner's or Physical Manufacturer's Declaration of Conformity): "Quality Management System Certificate: <Certification Body and Certificate Number, issue date, expiry date>". This is a new key: it does not restate or overwrite the held D12 row qms.gmp-or-iso-certificate-attached-to-application, which stays source-backed-partial against the National Trade Repository's measure page. The AMDD has no provision on quality-system audits of manufacturing sites by the Cambodian authority, and no provision on the validity or renewal of a registration — the Directive's terms 'audit', 'validity' and 'renew' have no occurrence in its text, which is why the D12 reading stops at the conformity-assessment and dossier-evidence obligations and why D16 could not be closed from it.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Field safety corrective action: duty to notify the authority and authority concurrence before closure

fsca.notification-and-closure-concurrence

Fact-level verified

When a dealer decides to initiate a field safety corrective action it must notify the Regulatory Authority; the time frame for that notification is prescribed by the Regulatory Authority of the Member State, and notification must not be delayed pending collation of distribution data. Reports are submitted in the authority's prescribed format, which may follow the ASEAN FSCA Report Form (Reference No. ASEAN-MDFR). The action is closed only when all appropriate corrective actions have been undertaken, subject to the concurrence of the Regulatory Authority.

Conditions

The product owner is responsible for determining the need for a field safety corrective action, by risk assessment under ISO 14971; the Regulatory Authority may instruct additional measures where it deems that assessment deficient.
The annex states these are recommended requirements Member States may replace with their own; the authority's own prescribed time frame and format override the recommended ones.
A field safety corrective action applies only to a device already distributed and may be needed after withdrawal from the market; product owner, physical manufacturer, authorised representative, importer and authorised distributor in the Member State are jointly responsible for performing and completing it.
The annex applies to all medical devices including IVD medical devices (Annex 5 §1.3).

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English. Quoted verbatim.

Authority power to withdraw, prohibit or restrict a device that may compromise health or safety

recall.authority-power-to-withdraw-or-restrict

Fact-level verified

Where the Regulatory Authority ascertains that a medical device placed on the market, when correctly installed, maintained and used for its intended purpose, may compromise the health or safety of patients, users or other persons, it must take all appropriate interim measures to withdraw that device from the market or to prohibit or restrict its being placed on the market or put into service, and must immediately inform the other Member States, indicating the reasons for its decision.

Conditions

The reasons must state in particular whether the measure is due to failure to meet the essential principles, incorrect application of the technical standards, or shortcomings in the technical standards themselves.
The provision is the instrument's safeguard clause and is the express market-withdrawal power; no separate Cambodian recall regulation was retrieved.
Applies in Cambodia through its Instrument of Acceptance of the ASEAN Medical Device Directive, deposited 27 March 2019.

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English. Quoted verbatim.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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National registration with the Cambodian regulatory authority required before market placement

pathways.national-registration-with-regulatory-authority

Fact-level verified

A medical device intended for the Cambodian market must be registered with Cambodia's own regulatory authority; the ASEAN Medical Device Directive under which Cambodia's controls are aligned provides that a device to be placed on the market of a Member State shall be registered with the Regulatory Authority of that Member State, that each Member State shall put in place an appropriate system for that registration, and that the authority may exempt certain devices from the registration requirement where appropriate.

Conditions

Registration is national: the AMDD creates no regional registration certificate, and Art. 6(1) ties placement to assessment by the Member State's own authority or bodies recognised by it.
The exemption in Art. 6(2) is discretionary ('may exempt ... where appropriate'); no Cambodian instrument listing exempt device categories was retrieved.
The two other carve-outs from registration are recorded in this file under special-access-derogation (custom-made devices, and public-health authorisation of unregistered devices).

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Upgrade in place of the round-204 row of this key: the row already cited Art. 6(2) but was held at source-backed-partial because Cambodia's national applicability rested on a signature page. The Instrument of Acceptance deposited 27 March 2019, recorded by the ASEAN Secretariat as the AMDD's depositary, closes that gap and is cited as the supporting source. Excerpt quoted verbatim from the ASEAN Secretariat publication.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Cambodia approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Cambodia (2 records)

CambodiaASEAN

Prior approval / evidence record

ASEAN Common Submission Dossier Template — harmonised dossier format only

reliance.asean-csdt-harmonised-dossier-format

Fact-level verified

Statement: Cambodia's device submission follows the ASEAN Common Submission Dossier Template (CSDT): the AMDD, which Cambodia has accepted, requires Member States to undertake appropriate measures to adopt and implement Annex 4 (CSDT) as a common technical document, alongside the post-marketing alert system (Annex 5) and the harmonised Declaration of Conformity elements (Annex 6). This is a harmonised dossier format only — it is not recognition of a foreign marketing approval, and the Cambodian authority's own review and decision are retained.
Source Approval: ASEAN Common Submission Dossier Template (CSDT)
Edge Type: Harmonized Dossier Only
Market Access Strength: Evidence Only
Regulatory Layer: Dossier Format
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Dossier-format harmonisation only; it creates no reliance on, or recognition of, any foreign approval.
AMDD Art. 22(2): the Agreement is in force only among Member States that have ratified and/or accepted it; Cambodia's Instrument of Acceptance was deposited on 27 March 2019.
Registry convention: the same mechanism is recorded for Thailand as edgeType 'harmonized_dossier_only', so this fact matches that shape rather than a route-shaped token.

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Upgrade in place of the round-204 row of this key, whose structured value is preserved unchanged; only the evidence grade changes, on the strength of the verbatim Art. 8 text and the deposited Instrument of Acceptance. Two reliance findings were deliberately NOT written as new facts this round: the origin-country certificate of sale and the optional other-country registration certificate in the national visa-registration attachment list are dossier evidence inside the national procedure, not a reliance route, and the existing sibling row (reliance.no-reference-country-or-abridged-route) already states that a foreign approval 'does not shorten or replace the Cambodian review' — so neither contradicts the rows that are there.

CambodiaASEAN

Prior approval / evidence record

Another ASEAN member state's device registration under the AMDD and the Common Submission Dossier Template

Authority: Another ASEAN member state's device registration under the AMDD and the Common Submission Dossier Template
Accepted: No
Benefit: The 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.

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 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 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 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 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

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

The MoH tariff sets a maximum service time of 100 working days for issuing a device/reagent visa-registration certificate (Joint Prakas 1356/2016, Annex 1 row 8)

clocks.visa-registration-maximum-100-working-days

Fact-level verified

Annex 1 of Joint Prakas 1356/2016 fixes, for the issuance of a visa-registration certificate for medical devices, reagents, external-use health-support products, traditional medicines and health supplements, a maximum service-delivery time of 100 working days (against 270 working days for medicines).

Conditions

Maximum published service time in the fee tariff, not a statutory review clock in Prakas 1258.
Recorded although review-clocks was not in the assigned open list, because the registry held no Cambodian clock.

Effective from 2016-11-18

English gist: column 'maximum period for service delivery (working days)'; the device row reads 400,000 riel / 100 days / 3 years.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

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Custom-made medical devices are not subject to product registration

access.custom-made-devices-exempt-from-product-registration

Fact-level verified

Custom-made medical devices are expressly not subject to product registration requirements. A custom-made device is one specifically made in accordance with a duly qualified medical practitioner's written prescription giving specific design characteristics under the practitioner's responsibility and intended for the sole use of a particular patient; mass-produced devices adapted to a practitioner's or other professional user's specific requirements are not custom-made devices.

Conditions

This is an express carve-out from the registration duty, not a discretionary waiver.
The definition and the carve-out sit in the same instrument; no Cambodian procedure for placing a custom-made device on the market was retrieved.
Applies in Cambodia through its Instrument of Acceptance of the ASEAN Medical Device Directive, deposited 27 March 2019.

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English. Quoted verbatim.

The authority may authorise use of unregistered devices in the interest or protection of public health

access.public-health-authorisation-of-unregistered-devices

Fact-level verified

Notwithstanding the registration and conformity-assessment duties, the Regulatory Authority of a Member State may, on a duly justified request or on its own initiative, authorise the use within its territory of medical devices that have not undergone registration, where that use is in the interest or protection of public health.

Conditions

The route is a power of the Regulatory Authority; no Cambodian application form, procedure or decision clock for it was retrieved.
It is the only derogation from registration in the instrument besides the custom-made carve-out; no compassionate-use, humanitarian or emergency device instrument specific to Cambodia was found, and general import waivers that do not name devices are not relied on here.
Applies in Cambodia through its Instrument of Acceptance of the ASEAN Medical Device Directive, deposited 27 March 2019.

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English. Quoted verbatim; the phrase 'Not with standing' is as printed in the ASEAN Secretariat publication.

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

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Class B, C and D dossiers must include the manufacturer's certificate of analysis and the technical file of Annex 2, on top of the GMP/ISO and free-sale certificates; class A files need no certificate of analysis (Prakas 1258, Arts. 5–6)

standards.manufacturer-certificate-of-analysis-for-classes-b-c-d

Fact-level verified

Article 6 of Prakas 1258 lists the visa-registration dossier for devices in classes B, C and D: the application (on the model form), a GMP certificate or an international standard (ISO) certificate (original or certified copy), the original free-sale certificate from the country of origin, registration certificates from other countries (if any), the analysis bulletin issued by the manufacturing establishment, the technical documents of Annex 2, and two samples or catalogues. Article 5 lists the class A dossier without the analysis bulletin, the technical file or foreign registration certificates.

Conditions

The class A list (Art. 5): application, GMP or ISO certificate, free-sale certificate (if any), letter of authorization, two samples or catalogues.
The DDF application template adds a Declaration of Conformity and, for disinfectants, a National Health Product Quality Control Centre analysis bulletin (see companion fact).

Effective from 2012-11-08

English gist: Article 6 — dossier for classes B, C and D: application (model form); GMP or ISO certificate (original or certified copy); original Free Sale Certificate; registration certificates in other countries (if any); analysis bulletin issued by the manufacturer; technical documents (Annex 2); 2 samples or catalogues. Transcribed from the scanned Khmer original (checked against the page image).

DDF's application template requires a National Health Product Quality Control Centre analysis bulletin for disinfectants and a Declaration of Conformity for every device/reagent application

standards.national-laboratory-analysis-bulletin-for-disinfectants-and-declaration-of-conformity

Fact-level verified

The DDF sample application letters for device/reagent registration, renewal and visa list among the mandatory attachments a quality-analysis bulletin issued by the National Health Product Quality Control Centre (ព្រឹត្តិបត្រវិភាគគុណភាពចេញដោយមជ្ឈមណ្ឌលជាតិពិសោធន៍សុខាភិបាល) for disinfectants, and a Declaration of Conformity (DoC) together with the Certificate of ISO/GMP.

Conditions

The national-laboratory bulletin is required only for disinfectants (ចំពោះ disinfectant); other devices file the manufacturer's analysis bulletin under Prakas 1258 Art. 6.
The DoC requirement appears in the DDF template, not in the 2012 Prakas.

English gist: one copy each of the National Health Product Quality Control Centre quality-analysis bulletin (for disinfectants), the FSC, the ISO/GMP certificate and the Declaration of Conformity.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

A classification dispute is decided by the authority and its decision is final

appeal.classification-dispute-decision-final

Fact-level verified

In a dispute between a Member State and any person over the classification of a medical device, the Regulatory Authority of that Member State decides the proper classification and its decision is final. This is the only express final-decision provision retrieved for a device decision; no separate reconsideration or appeal route against a registration decision was located, and the general administrative-law remedy for Cambodian administrative decisions is not asserted here because the instrument was not retrieved.

Conditions

The provision is confined to classification disputes; it is not a general appeals provision.
The decision being final also means the authority retains the classification decision entirely.
Applies in Cambodia through its Instrument of Acceptance of the ASEAN Medical Device Directive, deposited 27 March 2019.

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English. Quoted verbatim.

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

Importation and distribution records: contents and retention period

traceability.importation-and-distribution-records

Fact-level verified

Dealers must establish documented procedures for maintaining importation and/or distribution records and maintain such a record for each medical device, including low-risk devices exempt from product registration. The record must contain enough information to permit complete and rapid withdrawal from the market — the name and address of the initial consignee, identification and quantity of devices imported or shipped, the date, and any control number including lot, batch or serial number. It must be retained for the longer of the device's projected useful life as determined by the product owner, or two years after the device is shipped.

Conditions

The annex states these are recommended requirements that Member State Regulatory Authorities may adopt or replace with their own; no Cambodian adoption instrument was retrieved.
Dealer is defined to include the product owner, physical manufacturer, authorised representative or authorised distributor in a Member State who manufactured, imported, placed on the market or put into service the device.
The annex applies to all medical devices including IVD medical devices (Annex 5 §1.3).

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English. Quoted verbatim.

Traceability records must be kept and produced for inspection

traceability.record-keeping-and-inspection-duty

Fact-level verified

Any person responsible for manufacturing or placing medical devices on the market of a Member State must keep all relevant records pertaining to the traceability of the device, for such period and format as the national Regulatory Authority may stipulate, and must produce those records for inspection when the Regulatory Authority requires it.

Conditions

The period and format are expressly left to the national Regulatory Authority; no Cambodian period was retrieved.
Applies in Cambodia through its Instrument of Acceptance of the ASEAN Medical Device Directive, deposited 27 March 2019.
No UDI or unique device identification obligation was located in the AMDD, in the Cambodian measures and procedures on the National Trade Repository or on the department's website; no Cambodian authority statement that no UDI system exists was found either, so no negative is asserted.

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English. Quoted verbatim. The listing/registration limb of this dimension is the registry's existing registration-pathways row; the UDI limb is not evidenced (see conditions).

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

Post-marketing alert obligations under the AMDD

vigilance.asean-post-marketing-alert-obligations

Fact-level verified

Under the ASEAN framework binding Cambodia, anyone responsible for manufacturing or placing a device on the Cambodian market must keep traceability records and produce them for inspection, and must inform the regulatory authority, within the time and format it prescribes, when they become aware of any adverse event that has arisen or can arise from use of the device placed on the market, and when they perform or intend to perform a field safety corrective action on such a device.

Conditions

AMDD Art. 12 obligation; Cambodia's national reporting form, timescale and contact point are not published in the sources read this round.
Art. 12(2) also requires the Member State to inform the other Member States of incidents for which relevant measures have been taken or are contemplated.
Annex 5 §4.3 of the same instrument sets recommended reporting deadlines — immediately and not later than 48 hours for a serious threat to public health, 10 days for death or serious deterioration in health, and 30 days where a recurrence might have that effect — with the clock starting when any dealer personnel, including a sales representative, becomes aware of the event, and Annex 5 §4.4 has reports submitted on the authority's prescribed format, which may follow the ASEAN AE Report Form (Reference No. ASEAN-MDAR); Annex 5 §1.2 lets Member States adopt those requirements or prescribe their own. These are recorded as conditions of the verified obligation rather than as a separate fact in this held dimension.

ASEAN Legal Instruments — Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Upgrade in place of the round-204 row of this key, which quoted Art. 12(3) in its note but was held at source-backed-partial for lack of an official text; the verbatim article and the deposited Instrument of Acceptance supply it. Excerpt quoted verbatim from the ASEAN Secretariat publication.

Related structured datasets

Classification systems · 1 record

Open AMDD classes A, B, C and D applied by the Department of Drugs and Food →

cambodia:medical-device

Jurisdiction Id

cambodia

Domains

medical-device
ivd

Name

AMDD classes A, B, C and D applied by the Department of Drugs and Food

Description

Cambodia applies the ASEAN Medical Device Directive risk-class axis rather than a separate national taxonomy. AMDD Article 4(1) fixes four classes — A (low risk), B (low-moderate risk), C (moderate-high risk) and D (high risk) — with the classification rules for general devices in Annex 2 and for IVDs in Annex 3, and Article 4(6) requires a Member State that reclassifies or differs in applying those rules to notify the ASEAN Medical Device Committee with reasons. Cambodia's own implementing instrument is Prakas No. 1258 of 8 November 2012 on the Procedures for the Registration of Medical Devices, which the Department of Drugs and Food cites as the basis of the A–D framework; no official Cambodian domain publishes its text, so the national overlay is recorded in referenceSources as a located-but-unretrieved instrument and the class axis published here rests on the Directive. IVDs are classified on the same A–D axis under Annex 3, and the class is declared in the dossier the applicant files through CamPORS.

Classes

Id
a
Label
Class A
Normalized Risk Level
low
Id
b
Label
Class B
Normalized Risk Level
medium
Id
c
Label
Class C
Normalized Risk Level
high
Id
d
Label
Class D
Normalized Risk Level
highest

Regulator

Department of Drugs and Food

Official Domains

asean.org
agreement.asean.org

Source Status

official-source-verified

Reference Sources

Title
ASEAN Secretariat depositary table for the ASEAN Medical Device Directive — Cambodia Instrument of Acceptance, 27 March 2019
Url
https://agreement.asean.org/agreement/detail/307.html
Reviewed On
2026-09-16
Supports
Cambodia is a party to the Directive, so the Article 4(1) class axis and the Annex 2/Annex 3 classification rules apply to it nationally and not merely as a regional reference. The depositary table was retrieved and read in round 204, which is where the 27 March 2019 Instrument of Acceptance date and the nine-member ratification table come from; that round reached the page by computing the challenge cookie its own script sets, and this round did not re-attempt it. The claim therefore rests on the round-204 reading rather than on a fresh fetch, and the date is carried from there rather than re-derived.

Source Title

ASEAN Medical Device Directive, Article 4(1) with Annex 2 (Risk Classification Rules for Medical Devices other than IVD Devices) and Annex 3 (Risk Classification Rules for IVD Devices)

Source Url

https://asean.org/wp-content/uploads/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf

Verified On

2026-09-16

Source Supports

class-axis
classification-rules

Registration pathways, prior approvals and planning · 1 record

Open Cambodia registration →

Country

Cambodia

Jurisdiction Id

cambodia

Country Code

Flag

🇰🇭

Regulator

Department of Drugs and Food, Ministry of Health

Regulator Abbrev

Department of Drugs and Food

Region

asia-pacific

Tier

Risk Classification

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)

Classes

Id
trc-qualified-agent-certificate
Class Name
TRC qualified-agent certificate — importer, supplier and distributor of radiocommunication, telecommunication and ICT equipment
Pathway
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))
Official Timeline
Min
15
Max
15
Unit
working-days
Verification Status
official-verified
Official Source
Title
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
Url
https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/G/LIC/N3KHM6.pdf
Accessed Date
2026-09-16
Realistic Timeline
Min
3
Max
6
Unit
weeks
Notes
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.
The certificate is valid for two years and may be renewed 30 days before expiry; it is not transferable.
Only a firm registered in Cambodia can hold it, and only a holder can obtain a type approval or an import permit — this is the importer-side clock, not the device clock.
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
trc-type-approval-certificate
Class Name
TRC type-approval certificate — per equipment model
Pathway
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))
Official Timeline
Min
15
Max
15
Unit
working-days
Verification Status
official-verified
Official Source
Title
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
Url
https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/G/LIC/N3KHM6.pdf
Accessed Date
2026-09-16
Realistic Timeline
Min
3
Max
8
Unit
weeks
Notes
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.
The notification records the validity as permanent — a lifetime validity for the model, recorded here as the instrument's own wording rather than as a renewal cycle.
Applies to a medical device only where the device is radiocommunication, telecommunication or ICT equipment; a device without that feature does not take this clock.
Prakas No. 499 of 8 May 2018 sets the type-approval tariff at an 80,000 riel application fee and a 4,000,000, 6,000,000 or 8,000,000 riel certificate fee by service line — a radio-equipment charge, so it is not published in the Cambodian fee dataset.
Clinical Trial Required
No
Local Testing Required
Yes
Gmp Required
No
Id
trc-restricted-goods-import-permit
Class Name
TRC import permit — restricted radiocommunication and ICT goods
Pathway
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
Official Timeline
Min
3
Max
3
Unit
working-days
Verification Status
official-verified
Official Source
Title
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
Url
https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/G/LIC/N3KHM6.pdf
Accessed Date
2026-09-16
Realistic Timeline
Min
1
Max
3
Unit
weeks
Notes
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.
One permit covers one shipment and the permit is not transferable.
The permit is keyed to the HS headings listed in Annex 2 of Sub-Decree No. 370, which are networking, transmission, camera, drone and parts headings; a medical device is caught only where its heading is on that list.
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
ddf-device-registration
Class Name
Class A, B, C and D — Department of Drugs and Food medical-equipment visa registration (វិញ្ញាបនបត្រទិដ្ឋាការ បញ្ជីការ សម្ភារៈ បរិក្ខារពេទ្យ)
Pathway
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
Official Timeline
Min
3
Max
4
Unit
months
Verification Status
official-verified
Official Source
Title
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
Url
https://lib.ncdd.gov.kh/storage/app/public/library_backend/CAT_12377_1/2016-Public%20Service%20Information_MOH.pdf
Accessed Date
2026-09-16
Realistic Timeline
Min
3
Max
8
Notes
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.
This replaces the row's earlier verified negative: no retrievable Cambodian instrument states a decision period is still true of the ASEAN Medical Device Directive (Article 6 obliges a registration system and states no period) and of the National Trade Repository page for this procedure, but the Ministry's own consolidated schedule does state one, as a service standard.
The schedule's Khmer is set partly in legacy-mapped fonts, so extraction interleaves correct Unicode with substituted glyphs; everything published here rests on the Khmer and Arabic digits, which survive the substitution, and on a service identity confirmed by three independent match points against the official National Trade Repository page for the same procedure — the 400,000 riel fee, the three-year validity and the renewal at 70% of the original price. The most consequential silence in this route is that neither official description states a deadline for the applicant to return a corrected file, which is what makes the published 3-4 months unenforceable in practice.
Registration is per device; no Cambodian instrument retrieved permits grouping several devices under one registration.
The row is route-wide rather than class-specific because the schedule fixes one period for the service across classes A to D, which is why it carries a risk-class-link exemption rather than a class link.
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
ddf-import-licence
Class Name
Any class — Department of Drugs and Food import licence, per consignment (pharmaceuticals, medical materials and traditional medicines)
Pathway
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
Official Timeline
Min
10
Max
10
Unit
working-days
Verification Status
official-verified
Official Source
Title
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
Url
https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/G/LIC/N3KHM6.pdf
Accessed Date
2026-09-16
Realistic Timeline
Min
2
Max
4
Unit
weeks
Notes
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'.
Item 7(d): 'The license application is considered, and the license granted by a single organ, the Department of Drugs and Food, Ministry of Health.'
This is an import licence, not a registration: it sits alongside, not in place of, the DDF device registration row above. Item 8 of the same section makes the registration the gate — a licence 'may be refused only if it fails to meet the ordinary criteria, i.e., if the drug is not registered with the Ministry of Health' — so the 3-4-month registration clock and this 10-working-day consignment clock are different gates and both belong in the dataset.
The section is headed 'PHARMACEUTICALS, MEDICAL MATERIALS AND TRADITIONAL MEDICINES' and item 4 describes the system as covering 'pharmaceuticals, medical materials, legitimate medicines and traditional medicines', so medical materials and devices imported into Cambodia take this consignment licence. The instrument says 'working days' and is recorded in the working-days unit.
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
mme-donst-radiation-authorisation
Class Name
MME/DONST permission letter to import radioactive substances and radioactive sources, and the underlying licence to use them
Pathway
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
Official Timeline
Min
45
Max
45
Unit
days
Verification Status
official-verified
Official Source
Title
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
Url
https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/G/LIC/N3KHM6.pdf
Accessed Date
2026-09-16
Realistic Timeline
Min
2
Max
4
Notes
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.
This replaces the row's earlier verified negative. That negative was correct as to the document it rested on — Cambodia's national report to the Convention on Nuclear Safety describes the licensing system and the licence-holder duties and states no processing period — and this round re-read that report and confirms the silence. The country's own WTO notification supplies the period instead, and supplies it twice.
The decision clock runs on the authority; the applicant-facing items are separate. The permission letter is valid for no later than two years and permits one import only during its validity (items II and VI), and a re-application is required if nothing is imported in that period. The notification also states in terms that there is no advance-importation window and no shorter time limit for goods arriving at the port without a licence (item 6).
Reaches a medical device only where the device is an irradiating apparatus or uses radioactive sources (radiotherapy and nuclear-medicine equipment).
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No

Prior Approvals

Authority
Another ASEAN member state's device registration under the AMDD and the Common Submission Dossier Template
Accepted
No
Benefit
The 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.

Local Rep Required

Yes

Local Rep Name

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)

Mdsap Accepted

Mdsap Benefit

No Cambodian instrument retrieved recognises MDSAP, ISO 13485 or a foreign GMP certificate in place of dossier review; the AMDD route recognises conformity with technical standards recognised by the ASEAN Medical Device Committee (Article 9(1)), which is a standards reference rather than a QMS-certificate acceptance.

Registration Validity

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.

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources

Title
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
Url
https://lib.ncdd.gov.kh/storage/app/public/library_backend/CAT_12377_1/2016-Public%20Service%20Information_MOH.pdf
Accessed Date
2026-09-16
Title
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
Url
https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/G/LIC/N3KHM6.pdf
Accessed Date
2026-09-16
Title
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
Url
https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/G/LIC/N3KHM6.pdf
Accessed Date
2026-09-16
Title
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
Url
https://asean.org/wp-content/uploads/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf
Accessed Date
2026-09-16
Title
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
Url
https://www.iaea.org/sites/default/files/24/02/9th_cns_rm_cambodia.pdf
Accessed Date
2026-09-16

Reviewed On

2026-09-16

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather 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).
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to Department of Drugs and Food including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
Department of Drugs and Food reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. Department of Drugs and Food may issue questions.
Duration
15 working days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, Department of Drugs and Food issues Cambodia market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 0 records

No maintained record.

Additional certifications and licences · 1 record

Open Cambodia certifications →

Slug

cambodia

Market

Cambodia

Confidence

high

Schemes

Id
cambodia-trc-type-approval
Name
TRC type approval of radiocommunication, telecommunication and ICT equipment
Category
Radio Spectrum
Status
Mandatory Pre Market
Object
Radiocommunication Telecommunication Or Ict Equipment
Note
All radiocommunication, telecommunication and ICT equipment and devices require Type Approval before import and use in Cambodia. The duty is Article 16(b) of the Law on Telecommunications, promulgated by Royal Kram No. នស/រកម/1215/017 dated 17 December 2015, and Article 7(b) of Sub-Decree No. 110 ANK/BK dated 21 July 2017 on Granting Permit for Information and Communication Technology Operations; the certificate is issued per model by the Telecommunication Regulator of Cambodia, an entity attached to the Ministry of Post and Telecommunications, and Prakas No. 208 dated 29 December 2010 on Certification of Type Approval for Radiocommunications and Telecommunications Equipment sets the certification basis. Cambodia's own notification reports approval within 15 business days and a certificate valid for the lifetime of the model. It applies to a medical device only where the device is radiocommunication, telecommunication or ICT equipment — a wireless monitor, a telemetry module, a device with a cellular or Wi-Fi radio — and it is not the Department of Drugs and Food registration.
Source Urls
https://lic-public.wto.org/en/product-categories/181/procedure
Source Binding
reviewed
Id
cambodia-trc-qualified-agent-certificate
Name
TRC qualified-agent certificate for importation, supply and distribution
Category
Telecom Network Attachment
Status
Mandatory At Import
Object
Importer Or Qualified Agent
Note
Importers of radiocommunication, telecommunication and ICT equipment and devices must first obtain a Qualified Agent certificate for Importation, Supply and Distribution, under Article 16(a) of the Law on Telecommunications and Article 7(a) of Sub-Decree No. 110. Only firms registered in Cambodia can apply, and only firms already holding the certificate can apply for a type approval or an import permit, so the certificate is the gate on the importer rather than on the device. The notification reports approval within 15 business days, a two-year validity renewable 30 days before expiry, and filing through the TRC online portal; it is not transferable.
Source Urls
https://lic-public.wto.org/en/product-categories/181/procedure
Source Binding
reviewed
Id
cambodia-restricted-goods-import-permit
Name
TRC import permit for restricted radiocommunication and ICT goods
Category
Import Conformity
Status
Mandatory At Import
Object
Restricted Radiocommunication Or Ict Equipment
Note
Where imported equipment falls in the restricted list of Sub-Decree No. 370 ANK/BK dated 28 December 2023 on the Enforcement of the List of Prohibited and Restricted Goods, an import permit is required; Annex 2 of that Sub-Decree lists the covered HS headings, which are networking, transmission, camera, drone and parts headings rather than medical headings. The permit is issued by the TRC through the National Single Window, generally within 3 business days where the model already holds a type approval, covers one shipment, and is not transferable. A medical device is caught only if its HS classification falls inside that list.
Source Urls
https://lic-public.wto.org/en/product-categories/181/procedure
Source Binding
reviewed
Id
cambodia-trc-emc-test-report
Name
EMC test evidence inside the TRC type-approval file
Category
emc
Status
Mandatory If Feature
Object
Radiocommunication Telecommunication Or Ict Equipment
Note
The TRC type-approval application must enclose a copy of the EMC test report, together with a safety test report and/or certificate, an EMF/SAR test report where applicable, RF test reports for radio equipment, the EU Declaration of Conformity or EU Type Examination Certificate, and the technical specification. The requirement is therefore dossier evidence attached to the type approval rather than a separate Cambodian EMC certificate, and it reaches a medical device only through the radio/telecom/ICT route described in the type-approval row.
Source Urls
https://lic-public.wto.org/en/product-categories/181/procedure
Source Binding
reviewed
Id
cambodia-amdd-electrical-safety-evidence
Name
Electrical-safety and performance evidence inside the AMDD dossier
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
Cambodia has no separate electrical-safety certification for medical devices. AMDD Article 3 requires a device to meet the essential principles of safety and performance in Annex 1, Article 9(1) provides that conformity with technical standards recognised by the ASEAN Medical Device Committee or accepted by the national Regulatory Authority is deemed to comply with those principles, and Article 8(a) requires Member States to adopt the ASEAN Common Submission Dossier Template in Annex 4 as the technical document for the device. The safety and performance evidence is therefore an element of the registration dossier filed with the Department of Drugs and Food, not a certificate issued by a third Cambodian authority; no Cambodian instrument retrieved names the IEC 60601 series or any other standard set as mandatory.
Source Urls
https://asean.org/wp-content/uploads/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf
Source Binding
reviewed
Id
cambodia-mme-donst-ionizing-radiation-licence
Name
MME/DONST licence and import permit for radioactive sources and ionizing-radiation equipment
Category
Ionizing Radiation
Status
Mandatory For Use Site
Object
Radioactive Substances Sources And Irradiating Apparatus
Note
Cambodia's nuclear and ionizing-radiation safety, security and safeguards function sits with the Ministry of Mines and Energy, exercised through its Department of Nuclear Science and Technology, which acts as the national regulatory authority for ionizing-radiation sources and radioisotopes. In April 2021 the MME adopted a Prakas on the control of importing and use of radioactive materials and radioactive sources, and Cambodia's own national report records that operators hold an operation licence and an import permit issued by MME/DONST, that the licence conditions oblige the holder to appoint a radiation safety officer, to report radiation dose records to the General Department of Energy every two months, and to give 60 days' written notice before decommissioning. The report also states plainly that the comprehensive nuclear law is still in draft, so the regime rests on the MME Prakas and the ministry's establishment instruments (Royal Decree #1213/017 of 6 December 2013 and Sub-decree #137 of 31 October 2018) rather than on a nuclear law. The Prakas text itself was not retrieved, so this row's binding is candidate.
Source Urls
https://www.iaea.org/sites/default/files/24/02/9th_cns_rm_cambodia.pdf
Source Binding
reviewed

Official Sources

Authority
World Trade Organization — Import Licensing Notification Portal, Cambodia notification G/LIC/N/3/KHM/6 (published 09/04/2025)
Topic
TRC qualified-agent certificate, type approval and restricted-goods import permit: legal basis, periods, validity, document lists and fees under Prakas No. 499 of 8 May 2018
Url
https://lic-public.wto.org/en/product-categories/181/procedure
Authority
ASEAN Secretariat — ASEAN Medical Device Directive, 2015
Topic
classification, conformity assessment, registration, technical documents and reference technical standards adopted by Cambodia
Url
https://asean.org/wp-content/uploads/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf
Authority
Ministry of Mines and Energy — Department of Nuclear Science and Technology (DONST), Kingdom of Cambodia
Topic
national report to the Convention on Nuclear Safety: MME/DONST licensing of radioactive substances and sources, licence-holder conditions and the April 2021 Prakas
Url
https://www.iaea.org/sites/default/files/24/02/9th_cns_rm_cambodia.pdf
Authority
Department of Drugs and Food (DDF), Ministry of Health
Topic
CamPORS — the online registration system through which device, drug, cosmetic and supplement dossiers are filed
Url
https://ddf.moh.gov.kh/

Keep researching this market

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Continue with this market

Need to apply Cambodia's requirements to a product?

Confirm the current Department of Drugs and Food pathway, evidence, and local-role details for the actual device before filing.

Pricing

Advertising, claims & promotion

Medical device claims are subject to regulatory control and must be justified by substantial evidence

Approval validity & renewal

When a variation changes certificate particulars a new certificate is issued dated from its issue but keeping the original expiry date (Prakas 4206, Art. 7)

The DDF renewal template requires a copy of the most recent device/reagent certificate and states the renewal round number (DDF sample renewal letter)

The three-year certificate runs from its issue date and the holder must file the renewal dossier (Arts. 5–7 documents) six months before expiry (Prakas 1258, Art. 9)

Change control

Variations are classed as major, minor or simplified minor according to the MoH Guideline on product variations of 26 March 2019, which serves as the technical reference (Prakas 4206, Arts. 4–5)

Devices differing in trade name, presentation, size or manufacturing plant must be registered separately (Prakas 1258, Art. 10)

Varying a registered product without authorisation exposes the holder to suspension, withdrawal or cancellation of the certificate or a fine under the Law on the Management of Pharmaceuticals (Prakas 4206, Art. 11)

A variation is filed by the licensed manufacturer, import-export establishment or representative office with an application in Khmer, the certificate, a letter of reasons and the guideline's technical documents (Prakas 4206, Arts. 6–7)

Prakas 4206 establishes the post-registration variation procedure and defines the products covered to include medical devices and reagents (Arts. 1, 3–4)

Variations not provided for in the variation guideline require a fresh visa-registration application (Prakas 4206, Art. 10)

Clinical investigation & performance

Clinical evidence may come from investigations conducted domestically or in other countries

A device for clinical investigation may be required to be registered with the authority where the investigation is conducted

Device definition & scope

Products expressly outside the device regime

Definition of a medical device and of an accessory, and treatment of accessories as devices

Dossier requirements

Technical documentation follows the ASEAN CSDT

Economic-operator roles

The person responsible for placing devices on the market must be licensed

Fees

The import permit for medicines, medical devices and cosmetics costs 200,000 riel per consignment, issued within 10 working days and valid six months (Joint Prakas 1356/2016 Annex 1 row 11; NTR Note 4)

The fee for a variation application is the one fixed by joint prakas of the Ministers of Health and of Economy and Finance (Prakas 4206, Art. 8)

The MoH public-service tariff prices the visa-registration certificate for medical devices/reagents at 400,000 riel, valid three years (Joint Prakas 1356/2016, Annex 1 row 8)

Label, IFU & language

Mandatory and general label content of the applicable labelling annex

Labelling must meet the placing Member State's requirements; the national-language requirement is optional for the State

Legal basis & guidance

ASEAN Medical Device Directive in force for Cambodia from 27 March 2019

ASEAN Medical Device Directive — Cambodian signature

Manufacturer PMS

Dealer complaint-handling system and complaint-record retention of five years beyond projected useful life

Post-market clinical follow-up studies driven by residual risk, feeding the surveillance programme

Official forms & portals

Visa-registration application documents for medical and dental devices must be written in Khmer, English or French (Prakas 1258, Art. 8)

DDF publishes official sample application letters for medical-device/reagent registration, renewal and visa that cite Prakas 1258 and list the mandatory attachments

QMS, audit & inspection

ASEAN-level conformity assessment by the authority or appointed bodies, and the quality-assurance evidence required for each manufacturing facility

Recall, FSCA & market surveillance

Field safety corrective action: duty to notify the authority and authority concurrence before closure

Authority power to withdraw, prohibit or restrict a device that may compromise health or safety

Registration pathways

National registration with the Cambodian regulatory authority required before market placement

Reliance & recognition

Cambodia approvals and evidence in other markets (0 records)

Prior approvals and evidence for Cambodia (2 records)

ASEAN Common Submission Dossier Template — harmonised dossier format only

Another ASEAN member state's device registration under the AMDD and the Common Submission Dossier Template

Review clocks

The MoH tariff sets a maximum service time of 100 working days for issuing a device/reagent visa-registration certificate (Joint Prakas 1356/2016, Annex 1 row 8)

Special access & derogation

Custom-made medical devices are not subject to product registration

The authority may authorise use of unregistered devices in the interest or protection of public health

Standards, testing & ancillary approvals

Class B, C and D dossiers must include the manufacturer's certificate of analysis and the technical file of Annex 2, on top of the GMP/ISO and free-sale certificates; class A files need no certificate of analysis (Prakas 1258, Arts. 5–6)

DDF's application template requires a National Health Product Quality Control Centre analysis bulletin for disinfectants and a Declaration of Conformity for every device/reagent application

Submission communications & appeal

A classification dispute is decided by the authority and its decision is final

UDI, listing & traceability

Importation and distribution records: contents and retention period

Traceability records must be kept and produced for inspection

Vigilance & incident reporting

Post-marketing alert obligations under the AMDD

Related structured datasets

More Cambodia medical device resources