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Department of Drugs and Food Β· structured requirements

πŸ‡°πŸ‡­ Cambodia IVD regulatory data

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

27 facts14 dimensions7 official sourceslatest verification 2026-09-17

Changes after registration

Explore questions and sources β†’

Common questions about changing a registered IVD in Cambodia. Each question separates published rules from details still awaiting verification.

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 ('αžŸαŸ†αžŽαžΎαžŸαž»αŸ†αž”αž“αŸ’αžαžŸαž»αž–αž›αž—αžΆαž–αž”αž‰αŸ’αž‡αž·αž€αžΆβ€¦αž›αžΎαž€αž‘αžΈβ€¦') 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 β€” 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 β€” 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 β†’ 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 ('αž‡αžΆαž—αžΆαžŸαžΆαž‡αžΆαžαž·').

English gist: Art. 6 β€” variations may be requested through manufacturers, import-export establishments or representative offices holding an MoH decision; Art. 7 β€” 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 β€” 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) β€” '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 β€” Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

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

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 β€” 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 β€” 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.

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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All medical equipment, including imports, requires MOH visa registration; applications must attach GMP or ISO

establishment.visa-registration-required-for-imports
Fact-level verified

Cambodia’s National Trade Repository records Prakas No. 1258 as requiring Ministry of Health visa registration for all medical equipment, including imports, and attachment of GMP or ISO certification to the visa-registration application.

Conditions
  • This fact describes the two measures recorded in the National Trade Repository; it does not establish a complete importer-licensing procedure.

NTR record of Prakas 1258; the Khmer original is not translated in the repository (flagged "NO TRANSLATION AVAILABLE"), so the fact is scoped to the measure record.

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 αŸ‘αžαŸ‚).

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 β€” 200,000 riel β€” 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).

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 Β§1.3).
ASEAN Legal Instruments β€” 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 β€” 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 β€” a request for registration (αž”αž‰αŸ’αž‡αž·αž€αžΆ) of medical devices/reagents, a request for renewal of validity, and a request for a visa (αž‘αž·αžŠαŸ’αž‹αžΆαž€αžΆαžš) by a manufacturer or import-export establishment β€” 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 β€” given as quality assurance certificates issued by an accredited third-party inspection body β€” 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 β€” 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 β€” 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 Β§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 Β§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 β€” 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 Β§1.3).
ASEAN Legal Instruments β€” Document Detail: ASEAN Agreement on Medical Device Directive, Instruments of Ratification

Source is English. Quoted verbatim.

Review clocks

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

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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.

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 β€” 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 (αž–αŸ’αžšαžΉαžαŸ’αžαž·αž”αžαŸ’αžšαžœαž·αž—αžΆαž‚αž‚αž»αžŽαž—αžΆαž–αž…αŸαž‰αžŠαŸ„αž™αž˜αž‡αŸ’αžˆαž˜αžŽαŸ’αžŒαž›αž‡αžΆαžαž·αž–αž·αžŸαŸ„αž’αž“αŸαžŸαž»αžαžΆαž—αž·αž”αžΆαž›) 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 (αž…αŸ†αž–αŸ„αŸ‡ 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.

UDI, listing & traceability

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

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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 β€” 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 Β§1.3).
ASEAN Legal Instruments β€” 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 β€” 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 Β§4.3 of the same instrument sets recommended reporting deadlines β€” 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 β€” with the clock starting when any dealer personnel, including a sales representative, becomes aware of the event, and Annex 5 Β§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 Β§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 β€” 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 Β· 1 record
Open AMDD classes A, B, C and D applied by the Department of Drugs and Food β†’
Id

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 β€” A (low risk), B (low-moderate risk), C (moderate-high risk) and D (high risk) β€” 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 β€” 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 Β· 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Cambodia registration β†’
Country

Cambodia

Jurisdiction Id

cambodia

Country Code

KH

Flag

πŸ‡°πŸ‡­

Regulator

Department of Drugs and Food, Ministry of Health

Regulator Abbrev

Department of Drugs and Food

Region

asia-pacific

Tier

3

Risk Classification

4-class (A, B, C, D) β€” 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 β€” 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) β€” Β§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 β€” 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 β€” 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) β€” Β§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 β€” 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 β€” 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 β€” 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) β€” Β§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 β€” Department of Drugs and Food medical-equipment visa registration (αžœαž·αž‰αŸ’αž‰αžΆαž”αž“αž”αžαŸ’αžšαž‘αž·αžŠαŸ’αž‹αžΆαž€αžΆαžš αž”αž‰αŸ’αž‡αžΈαž€αžΆαžš αžŸαž˜αŸ’αž—αžΆαžšαŸˆ αž”αžšαž·αž€αŸ’αžαžΆαžšαž–αŸαž‘αŸ’αž™)

    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

    αž–αŸαžαŸŒαž˜αžΆαž“αžŸαŸαžœαžΆαžŸαžΆαž’αžΆαžšαžŽαŸˆαžšαž”αžŸαŸ‹αž€αŸ’αžšαžŸαž½αž„αžŸαž»αžαžΆαž—αž·αž”αžΆαž› αž“αž·αž„αž”αž…αŸ’αž…αž»αž”αŸ’αž”αž“αŸ’αž“αž—αžΆαž–αž†αŸ’αž“αžΆαŸ†αŸ’αŸ αŸ‘αŸ¦ β€” Ministry of Health Public Service Information, 2016 update, pp. 44-45: the medical-equipment visa-registration service, its 'αžšαž™αŸˆαž–αŸαž›αž•αŸ’αžαž›αŸ‹αž‡αžΌαž“' 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 β€” 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 'αžšαž™αŸˆαž–αŸαž›αž•αŸ’αžαž›αŸ‹αž‡αžΌαž“' (period provided) field for this service with 3-4 months and decomposes it into four one-month stages β€” 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 β€” 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 β€” 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) β€” Β§11 Pharmaceuticals, medical materials and traditional medicines (DDF import licence, 10 working days), Β§13 Radioactive chemical elements and isotopes (MME permission letter, 45 days) and Β§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, Β§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 β€” 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' β€” 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) β€” Β§11 Pharmaceuticals, medical materials and traditional medicines (DDF import licence, 10 working days), Β§13 Radioactive chemical elements and isotopes (MME permission letter, 45 days) and Β§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, Β§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 β€” Cambodia's national report to the Convention on Nuclear Safety describes the licensing system and the licence-holder duties and states no processing period β€” 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 Β§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 β€” where its heading is in Annex 2 of Sub-Decree No. 370 β€” 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 β€” 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

No

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 β€” the Ministry of Health's Public Service Information (2016 update) prints 'αžŸαž»αž–αž›αž—αžΆαž– αŸ£αž†αŸ’αž“αžΆαŸ†' (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 Β§14), and those are radio and telecom certificates, not the device registration.

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    αž–αŸαžαŸŒαž˜αžΆαž“αžŸαŸαžœαžΆαžŸαžΆαž’αžΆαžšαžŽαŸˆαžšαž”αžŸαŸ‹αž€αŸ’αžšαžŸαž½αž„αžŸαž»αžαžΆαž—αž·αž”αžΆαž› αž“αž·αž„αž”αž…αŸ’αž…αž»αž”αŸ’αž”αž“αŸ’αž“αž—αžΆαž–αž†αŸ’αž“αžΆαŸ†αŸ’αŸ αŸ‘αŸ¦ β€” Ministry of Health Public Service Information, 2016 update, pp. 44-45: the medical-equipment visa-registration service, its 'αžšαž™αŸˆαž–αŸαž›αž•αŸ’αžαž›αŸ‹αž‡αžΌαž“' 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) β€” Β§11 Pharmaceuticals, medical materials and traditional medicines (DDF import licence, 10 working days), Β§13 Radioactive chemical elements and isotopes (MME permission letter, 45 days) and Β§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) β€” Β§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 β€” 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 β€” 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

    πŸ“‹

  • 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

    πŸ“€

  • 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

    πŸ”

  • 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

    βš™οΈ

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, Department of Drugs and Food issues Cambodia market authorization certificate.

    Duration

    1-2 weeks

    Icon

    βœ…

Government fee schedules Β· 0 records

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

No maintained record.

Additional certifications and licences Β· 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Cambodia certifications β†’
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. αž“αžŸ/αžšαž€αž˜/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 β€” a wireless monitor, a telemetry module, a device with a cellular or Wi-Fi radio β€” 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 β€” 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 β€” 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 β€” 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 β€” the online registration system through which device, drug, cosmetic and supplement dossiers are filed

    Url

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

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More Cambodia medical device resources

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